Effect of Powerbreath Medic Plus versus Threshold IMT on maximal inspiratory pressure and functional capacity in post-operative ventricular septal defect closure: A protocol for a randomized controlled trial

Chitrakshi A Choubisa; Vishnu Vardhan

doi:10.12688/f1000research.135484.1

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Study Protocol

Effect of Powerbreath Medic Plus versus Threshold IMT on maximal inspiratory pressure and functional capacity in post-operative ventricular septal defect closure: A protocol for a randomized controlled trial

[version 1; peer review: 1 approved with reservations]

Chitrakshi A Choubisa ¹, Vishnu Vardhan¹

PUBLISHED 07 Aug 2023

Author details Author details

¹ Cardiovascular and Respiratory Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Chitrakshi A Choubisa
Roles: Conceptualization, Methodology, Writing – Original Draft Preparation

Vishnu Vardhan
Roles: Supervision, Validation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background: Congenital heart disease is a general phrase that refers to any heart conditions that exist at birth, the most prevalent of which being ventricular septal defects (VSD) and foetal congenital malformations. VSD refers to the presence of aperture between the ventricles which leads to mixing of oxygenated and de-oxygenated blood. Although many VSDs close on their own, failing to do so can result in a number of issues and typically necessitates open heart surgery for closure of the defect. According to various studies, there is reduced functioning of diaphragm post cardiac surgeries which leads to occurrences of pulmonary complications such as lung collapse, fluid accumulation in pleura, pneumonia, acute respiratory distress syndrome and pneumothorax which can be debilitating and jeopardize recovery as well as increase hospital stay. There are several devices which are proven to improve the strength of inspiratory musculature and hence improve maximal inspiratory pressure and functional capacity post cardiac surgeries.
Method: In this study we aimed to assess and evaluate the effectiveness of Powerbreath Medic Plus and Threshold Inspiratory Muscle Trainer (IMT) adjunct to conservative physiotherapy management on subjects who underwent VSD closure in a two arm parallel superiority randomized control trial on improving maximal inspiratory pressure and functional capacity. 60 individuals in total will be allocated equally into two groups, and both groups will be receiving treatment for four weeks with five sessions per week. After four weeks of therapy and two weeks after the intervention is through, the results will be assessed for follow-up.
Predicted results: By increasing maximal inspiratory pressure and functional capacity, this technique may be used to treat complications following heart surgery if our study's premise is found to be significant.
CTRI registration: CTRI/2023/03/051090

Keywords

Ventricular septal defect closure, congenital heart disease, Powerbreath medic plus, threshold IMT, maximal inspiratory pressure, functional capacity.

Corresponding author: Chitrakshi A Choubisa

Competing interests: No competing interests were disclosed.

Grant information: Intramural grant has been obtained from Datta Meghe Institute of Higher Education and Research (reference no. DMIHER(DU) R&D/2023/233).
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2023 Choubisa CA and Vardhan V. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Choubisa CA and Vardhan V. Effect of Powerbreath Medic Plus versus Threshold IMT on maximal inspiratory pressure and functional capacity in post-operative ventricular septal defect closure: A protocol for a randomized controlled trial [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:939 (https://doi.org/10.12688/f1000research.135484.1) First published: 07 Aug 2023, 12:939 (https://doi.org/10.12688/f1000research.135484.1) Latest published: 07 Aug 2023, 12:939 (https://doi.org/10.12688/f1000research.135484.1)

Introduction

Congenital heart diseases (CHDs), one of the most frequent foetal defects, can occur in as many as 13 out of every 1000 live births.¹ CHDs are among the most prevalent foetal malformations. The most frequent acynotic congenital cardiac abnormalities in children are ventricular septal defects (VSD), which are the second most common congenital anomaly in adults.¹^,² Shunt formation and inappropriate right-to-left ventricular communication are the primary causes of hemodynamic compromise in VSD due to presence of aperture between the ventricles.³^,⁴ Many VSDs close on their own, however if they fail to, large defects can cause a number of problems, including pulmonary arterial hypertension (PAH), ventricular dysfunction, and a greater incidence of arrhythmias. If there are significant problems, the most common procedure in paediatric cardiac surgery is surgical closure of the ventricular septal defect.³^,⁵^–⁷

Transient diaphragm dysfunction is reportedly frequent in the initial week following cardiac surgery, based on numerous studies.⁸^,⁹ In patients receiving elective heart surgery, the prevalence of residual diaphragm dysfunction was 8%, and it was linked to poor respiratory outcomes.⁹^,¹⁰ Several pulmonary complications, such as collapse of the lung, collection of fluid in pleura, pneumonia, cardiogenic pulmonary oedema, acute respiratory distress syndrome, pulmonary embolism, phrenic nerve injury, pneumothorax, sternal wound infection and inflamation as well as longer hospital stays and prolonged ventilator support, are caused by diaphragmatic dysfunction.⁸^–¹² Furthermore, cardiac procedures impair breathing mechanics, decrease lung volume, obstruct gas exchange, affect the ventilation-to-perfusion ratio, lung capacities, and promote physical inactivity, all of which lower functional capacity.¹³^,¹⁴

Early ambulation and mobility, breathing exercises, coughing techniques, incentive spirometers, and strengthening of respiratory musculature are all cardiopulmonary physical therapy interventions that have been documented to be beneficial for lowering the occurrence of pulmonary problems.¹⁵ Patients having heart operations have shown possible positive effects from inspiratory muscle training (IMT).¹⁵ Numerous IMT devices are utilised to prevent diaphragmatic dysfunction and respiratory issues.¹⁵ Research on the application of Powerbreathe training and enhancing maximal inspiratory pressure in individuals who underwent VSD closure is scant. Data on physical therapy interventions and results in individuals who had VSD closure surgery are rare.

IMT improves the capacity for functional activity as well as respiratory muscle strength. The two main categories of IMT equipment are devices with pressure- and volume-based loading.¹⁶^,¹⁷ A pressure-based threshold device called Power Breathe (PwB) limits airflow during inspiration until it achieves a particular pressure. This inspiratory pressure is modifiable by adjusting the spring tension to match the patient’s maximal inspiratory pressure (MIP). The lineal resistance to the flow increment must be as low as possible when the pressure is surpassed and the valve is opened. Due to coupled action of respiratory musculature and the PwB device, higher lung charges of between 186 and 274 centimetres of water (cmH2O) pressure can be produced.¹⁸^,¹⁹ The most popular inspiratory muscle trainer for improvising the power and endurance of the respiratory musculature is the Threshold IMT, a pressure-based loading apparatus. It can provide resistance up to 41 cm H₂O and hence retraining the inspiratory muscles at different resistance levels.¹⁷

This article presents the protocol for the full study, whose objective is to assess and evaluate the effectiveness of the PowerBrethe medic plus device and the threshold IMT device in patients who underwent VSD closure in a two-arm parallel superiority/equivalence randomised control trial (RCT). The end point results will be compared on a marginal basis to determine effectiveness.

Aim and objectives

1. To assess and evaluate the subjects who underwent VSD closure, intervened with Power Breathe Medic Plus adjunct to conservative physiotherapy management and its effect on improving maximal inspiratory pressure (Micro Respiratory Pressure Meter) and functional capacity (6 Minute Walk Distance Test) in the entire populace.
2. To assess and evaluate the subjects who underwent VSD closure for the change in pulmonary function parameters (FEV1, FVC AND FEV1/FVC ratio) treated with Power Breathe Medic Plus adjunct to conservative physiotherapy management, to observe if it can improve pulmonary functioning in the entire populace.
3. To analyse the efficacy over the treatment of Power Breathe Medic Plus along with conventional physiotherapy management and Threshold IMT along with conventional physiotherapy management for bringing on change in maximal inspiratory pressure and functional capacity for the patients who underwent VSD closure.

Protocol

This protocol has been registered with CTRI (CTRI/2023/03/051090) on 27/03/2023.

Ethics and consent

This study will be conducted with written informed consent from all participants. Ethical approval was received from the institutional ethics committee (ref: DMIHER (DU)/IEC/2023/545) on 04/02/23.

Trial design

Single centric, two arm parallel equivalence randomized controlled trial. Participants in the study will be split into two groups. Group-A (Powerbreath and conservative physiotherapy management) and Group-B (Threshold IMT and conservative physiotherapy management) by randomization for 1:1 allocation with intent to treat purpose.

Participants and recruitment

Participants will be chosen from the Cardiovascular and Thoracic Surgery Unit at Acharya Vinobha Bhave Hospital Sawangi in Meghe, Wardha, Maharashtra, following approval from the institutional ethics committee of Datta Meghe Institute of Higher Education and Research. Potential participants will be identified through their medical records and evaluation. The participants will be screened as per inclusion and exclusion criteria followed by randomization using a computer-generated list. Allocation will be done by sequentially numbered opaque sealed envelopes. Allocation and participant enrolment will be done by the primary investigator. The therapist will be aware of the allocations. The inclusion and exclusion criteria for selection will be based on the cut-off values at baseline parameters when engaging participants. Throughout the six-month recruitment phase, a second source of recruitment will be used if more study participants are needed; this will be an additional local private hospital.

To compare improvements in maximal inspiratory pressure and functional capacity at the end point, the interventional group will receive Powerbreath and conservative physiotherapy management (Figure 1), and the control group will receive Threshold IMT and conservative physiotherapy management (Figure 1). Participants will be enrolled and evaluated at several intervals, including first visit and second visit for subject enrolment and screening respectively, baseline, 4 weeks, and 2 weeks after treatment for follow-up, when primary and secondary parameters will be measured. The study design is depicted in Figure 1.

Figure 1. Showing consort diagram of study protocol.

Inclusion criteria

1. Patients clinically diagnosed with isolated VSD.
2. Patients who have been operated on for VSD closure.
3. Age group of 10-18 years.
4. Patient’s guardian who will sign the consent form
5. Both male and female.
6. Patients with the ability to understand and follow instructions

Exclusion criteria

1. Patients with VSD associated with other congenital conditions such as Down’s syndrome, William’s syndrome, Noonan syndrome, and Turner syndrome.
2. Patients on a post-operative mechanical ventilator.

Experimental group intervention

After screening and randomization, the experimental group will receive inspiratory muscle training with PowerBreathe along with conservative physiotherapy management (Table 1) which will start from post-operative day 3 (POD-3). The training will be delivered in-person at the hospital. Initially the postoperative training will begin with 40% of the preoperative MIP recorded, and weekly load increases of 5–10% will be made based on the patient’s tolerability. The patient will obtain postoperative training for 20 to 30 minutes per session, which will consist of six sets of five deep breathes against the trainer device, with only a brief rest period of 1 to 2 minutes in between each set. Training will be done twice a day, every day, for four weeks.²⁰ The treatment will be discontinued or modified if patient is not willing to continue or faces any discomfort. To improve adherence to the treatment, counselling sessions will be arranged for patient and his/her family on how this device can be useful to improve lung function post-operatively along with various other medical interventions.

Table 1. Conservative physiotherapy management.

Sr No.	Exercise	Description	Dosage
1.	Diaphragmatic breathing exercises	Patient will be in sitting position, placing his/her hand over abdomen then patient is asked to inhale through nose and exhale through nose while feeling the abdominal raise.	10 repetitions with 5 sec hold and 2 sets
2.	Thoracic expansion exercises	Patient will be in sitting position then patient is asked to inhale deeply through nose along with raising both the arms and then exhale with lowering both the arms.	10 repetitions with 5 sec hold and 2 sets
3.	Active range of motion exercise for bilateral upper and lower limb	Patient is asked to perform Active range of motion exercises of shoulder, elbow, wrist, hip, knee and ankle.	2 sets of 10 repetitions

Control group intervention

After screening and randomization, the control group will receive inspiratory muscle training with Threshold IMT along with conservative physiotherapy management (Table 1) which will start from POD-3. The training will be delivered in-person at the hospital. Initially, the postoperative training will be 40% of the MIP that was observed pre-operatively, followed by an increase in load by 5–10% per week based on the tolerance of the patient. The patient will get postoperative training for 20 to 30 minutes per session, which will consist of six sets of five deep breaths against the trainer device, with only a brief rest period of 1 to 2 minutes in between each set. Training will be done twice a day, every day for four weeks.¹³ The treatment will be discontinued or modified if patient is not willing to continue or faces any discomfort. To improve adherence to the treatment, counselling sessions will be arranged for patient and his/her family on how this device can be useful to improve lung function post-operatively along with various other medical interventions.

Outcomes

Primary outcomes

• Change in maximal inspiratory pressure and MicroRPM reading (respiratory pressure meter).
MicroRPM demonstrated excellent inter-rater reliability for inspiratory pressure and good inter-rater reliability for expiratory pressure, as well as strong contemporaneous validity and test-retest reliability. In reference to concurrent validity for inspiratory and expiratory pressures, the intraclass correlation coefficientS (ICC) were 0.77 and 0.86, respectively. Inter-rater reliability revealed ICCs as 0.91 for inspiratory pressure and 0.84 for expiratory pressure, with test-retest reliability demonstrating an ICC of 0.87 for inspiratory pressure and 0.78 for expiratory pressure.²¹
• Change in 6 MWD (Minute Walk distance) Test.
The 6MWD is a submaximal exercise test that is quick and easy to administer and is well-tolerated by the patient. With an ICC of 0.90, it is a standardized field test to assess functional capacity after exercise performance in people with a range of cardiac and pulmonary problems.²²^,²³

Secondary outcomes

• Change in Pulmonary Function Test (PFT).
The simplest and most practical pulmonary function test (PFT) is spirometry, which measures air exhaled or inhaled during forceful movements. It is a quantifiable, repeatable, non-invasive, and comparatively easy technique for determining lung function. FEV1, FVC and FEV1/FVC ratio will be collected.²⁴

Safety outcomes

Adverse events will be reported at each time. No adverse effects are anticipated.

Sample size calculation

Sample size calculation resulted at 5% level of significance considering both the sides at 5% error probability with total 10 % for Z(1-α) value =1.64 & (1- β) at power of 80 % = 0.84 measuring the mean difference (effect size) of $(δ)$ = 10.3 & standard deviation ( $σ)$ = 15.75

Sample size calculation formula using mean difference:

n 1 = n 2 = 2 \frac{{(Z_{α} + Z_{β})}^{2} σ^{2}}{{(δ)}^{2}}

Primary variable (maximum inspiratory pressure)

Mean ± SD (pre) result on maximum inspiratory pressure for conventional chest therapy (control group) = 103 ±15

Mean ± SD (post) result on maximum inspiratory pressure for conventional chest therapy (control group) = 113.3 ±16.5

Difference in mean = 10.3

Pooled standard deviation = (15 + 16.5) / 2 = 15.75

As per reference article.²⁵

N1 = 2^{*} [{(1.64 + 0.84)}^{2} {(15.75)}^{2}] / {(10.3)}^{2} = 28

Considering 10% drop out = 2

Total samples required (n1 =n2 = 30 per Group)

Total sample size required (N) = 2*30 = 60

Assumptions

$Z_{α} = 1.64$

$α = Type I error at 5 %$

$Z_{β} = 0.84 (1 - β) = Power at 80 %$

$σ = Standard Deviation$

Reference article: Inspiratory muscle training and functional capacity following coronary artery bypass grafting in high-risk patients: A pilot randomized and controlled trial.²⁵

Data collection, management and analysis.

Analysis

All the results will be calculated using R studio software 4.3. Demographic variables as per the quantitative assessment will be nanalysed for the mean±SD and the frequency and percentage. Inferential statistic data with the variables will be tested for the normality using the Kolmogorov-Smirnov Test. A parametric test will be used if data follows normal distribution. The paired-t test will be used for pre- and post-analysis. Alternatively, the Wilcoxon Test will be used as a non-parametric test if the data are not normally distributed. Similarly, for the unpaired-t test, the Mann Whitney test will be used as an alternative. Association analysis for finding significance of cofounding parameters will be evaluated by using the Chi-squared test or Fisher’s exact test or by using multi-variant analysis. Sensitivity and specificity of the device will be tested over primary outcome (MIP). AUC (area under curve) will be calculated on the basis of observational values for finding accuracy of the device.

Primary outcome

Inferential statistics will be utilized to compare the two groups for their mean change in primary variable (MicroRPM and 6MWD Test) between baseline, 4 weeks and follow up after 2 weeks using the linear mixed model. The two groups will be active treatment versus control treatment. The participants’ responses will be evaluated in light of the major variable’s variation from baseline to the timeline measured during the study (visit 1 and after the conclusion of 4 weeks, and follow-up after 2 weeks after the conclusion of the intervention). For research participants, random effects will be generalised, and treatment group and visit count will be taken into consideration while analysing fixed effects. With a corresponding 95% confidence interval (CI), the effect size over the mean change difference on the major variable from baseline to end line visit at 4 weeks and 2 weeks follow up will be measured.

Primary end point (description)

In order to forecast the difference in impact size between the active and control groups, secondary outcomes (PFT) will be examined according to the aforementioned linear mixed model effect. If the data has a normal distribution, the t-test (unpaired) will be used to determine whether there is a significant difference between the means in comparison between the two groups. For non-normal distribution, the translation of the data to the normal distribution will be done using MATHEMATICAL algorithms. The alternative non-parametric tests (Chi square, Mann Whitney, and Wilcoxon tests) will be used if the data across the major variable still exhibit non-normal distribution.

Discussion

CHDs, specifically VSD, are commonly encountered condition in children as well as adults which, if they fail to close on their own, require open heart surgery for the closure of the defect.¹ Cardiac surgeries are used worldwide for treatment of patients with such heart conditions, and rates of post-operative complications are still significant, mainly involving pulmonary complications.³^,⁵ This study’s objective is to assess and evaluate the effectiveness of the PowerBrethe medic plus device and the Threshold IMT device in patients who underwent VSD closure. The end point results will be compared on a marginal basis to determine effectiveness.

In their non-blinded randomised controlled experiment, Rhoia Neidenbach et al. (2023) reported that the effects of IMT on lung capacity and exercise capacity were assessed in a sizable cohort of 40 Fontan patients. They discovered a noticeably better oxygen saturation, which is a clinically meaningful improvement.²⁶ In a randomised controlled trial conducted by Fatma A. Hegazy et al. in 2021, 100 patients who had undergone mitral valve replacement surgery participated. The researchers looked at the impact of postoperative high load, long duration inspiratory muscle training on pulmonary function and functional capacity using the Threshold IMT device. They discovered significant improvement in all measures (p 0.001) in the between-group study, and significant improvements in lung function, inspiratory pressure, and functional capacity (p 0.05) were found in the experimental group.¹³ In order to assess the effect of an inspiratory muscle strengthening programme using the PowerBreathe device on the ergogenic potential for respiratory and/or athletic performance, Diego Fernández-Lázaro et al. (2021) conducted a systemic review with meta-analysis. They came to the conclusion that the programme increased VO2 max, inspiratory muscle strength, pulmonary function, and sport performance.¹⁹ According to previous studies, training of inspiratory musculature is probably beneficial in increasing respiratory muscle strength, decreasing airway closure, and possibly even in enhancing breathing mechanics and lowering exercise-related dyspnea.²⁷ These mechanistic alterations reflect the developing understanding of the function of inspiratory training in paediatric patients and can be used to explain improvements in symptomology and clinical outcomes.²⁷

Dissemination

We are planning to present the study protocol and subsequent findings in conference proceedings.

Study status

The study has not yet started. Recruitment is expected to begin in July 2023.

Data availability

No data are associated with this protocol.

Reporting guidelines

SPIRIT checklist for ‘Effect of Powerbreath Medic Plus versus Threshold IMT on maximal inspiratory pressure and functional capacity in post-operative ventricular septal defect closure: A randomized controlled trial’, https://doi.org/10.5281/zenodo.7988644.²⁸

Acknowledgements

I would like to acknowledge Mr. Laxmikant Umate and Mr. Manoj Patil who have helped me in sample size calculation and data analysis planning.

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Author details Author details

¹ Cardiovascular and Respiratory Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Chitrakshi A Choubisa
Roles: Conceptualization, Methodology, Writing – Original Draft Preparation

Vishnu Vardhan
Roles: Supervision, Validation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

Intramural grant has been obtained from Datta Meghe Institute of Higher Education and Research (reference no. DMIHER(DU) R&D/2023/233).
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Published: 07 Aug 2023, 12:939

https://doi.org/10.12688/f1000research.135484.1

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© 2023 Choubisa CA and Vardhan V. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Choubisa CA and Vardhan V. Effect of Powerbreath Medic Plus versus Threshold IMT on maximal inspiratory pressure and functional capacity in post-operative ventricular septal defect closure: A protocol for a randomized controlled trial [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:939 (https://doi.org/10.12688/f1000research.135484.1)

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Reviewer Report 08 Nov 2023

Shane Patman, Faculty of Medicine, Nursing and Midwifery, and Health Sciences, The University of Notre Dame Australia, Perth, Australia

Approved with Reservations

https://doi.org/10.5256/f1000research.148605.r216838

Many thanks for the opportunity to contribute to the peer review process for the study protocol within F1000Research entitled 'Effect of Powerbreath Medic Plus versus Threshold IMT on maximal inspiratory pressure and functional capacity in postoperative ventricular septal defect closure: ... Continue reading

Many thanks for the opportunity to contribute to the peer review process for the study protocol within F1000Research entitled 'Effect of Powerbreath Medic Plus versus Threshold IMT on maximal inspiratory pressure and functional capacity in postoperative ventricular septal defect closure: A protocol for a randomized controlled trial'

General Comments

Suggest rephrasing throughout submission to avoid starting sentences with abbreviations or numbers (e.g. such as: Abstract, Background, line 4; Abstract, Method, line 6; Introduction, paragraph 1, line 2; Introduction, paragraph 4, line 1)

Suggest amending to depersonalize throughout submission (e.g. such as: Abstract, Method, line 1 ; Abstract, Predicted results, line 3)

The role of prehabilitation, some programs inclusive of the use of IMT, is a growing topic within contemporary literature within the adult major surgery cohorts (such as those listed below). It may be prudent for authors to acknowledge this topic and for them to comment as to why they are choosing to focus solely on the post-operative use of IMT in isolation for their project.

Yau, D. K. W., Underwood, M. J., Joynt, G. M., & Lee, A. (2021). Effect of preparative rehabilitation on recovery after cardiac surgery: A systematic review. Annals of physical and rehabilitation medicine, 64(2), 101391. https://doi.org/10.1016/j.rehab.2020.03.014
Steinmetz, C., Bjarnason-Wehrens, B., Walther, T., Schaffland, T. F., & Walther, C. (2023). Efficacy of Prehabilitation Before Cardiac Surgery: A Systematic Review and Meta-analysis. American journal of physical medicine & rehabilitation, 102(4), 323–330. https://doi.org/10.1097/PHM.0000000000002097
Olsen, D. B., Pedersen, P. U., & Noergaard, M. W. (2023). Prehabilitation before elective coronary artery bypass grafting surgery: a scoping review. JBI evidence synthesis, 21(6), 1190–1242. https://doi.org/10.11124/JBIES-22-00265
Assouline, B., Cools, E., Schorer, R., Kayser, B., Elia, N., & Licker, M. (2021). Preoperative Exercise Training to Prevent Postoperative Pulmonary Complications in Adults Undergoing Major Surgery. A Systematic Review and Meta-analysis with Trial Sequential Analysis. Annals of the American Thoracic Society, 18(4), 678–688. https://doi.org/10.1513/AnnalsATS.202002-183OC
Gibbison, B., Murphy, G. J., Akowuah, E., Loubani, M., & Pufulete, M. (2023). Pre-operative and prehabilitation services in UK cardiac surgery centres. Anaesthesia, 78(3), 388–391. https://doi.org/10.1111/anae.15918
Katsura, M., Kuriyama, A., Takeshima, T., Fukuhara, S., & Furukawa, T. A. (2015). Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. The Cochrane database of systematic reviews, 2015(10), CD010356. https://doi.org/10.1002/14651858.CD010356.pub2
Kendall, F., Oliveira, J., Peleteiro, B., Pinho, P., & Bastos, P. T. (2018). Inspiratory muscle training is effective to reduce postoperative pulmonary complications and length of hospital stay: a systematic review and meta-analysis. Disability and rehabilitation, 40(8), 864–882. https://doi.org/10.1080/09638288.2016.1277396
Noronha, J., Samuel, S., Singh, V. P., & Prabhu, H. S. (2022). Effects of exercise-based prehabilitation in children undergoing elective surgeries: a systematic review. F1000Research, 10, 1262. https://doi.org/10.12688/f1000research.74493.2

No reporting guidelines / checklists for this protocol project reporting are explicitly stated as being followed (such as TIDieR, SPIRIT) - to enhance the quality and transparency of health research reporting, authors are strongly encouraged to explicitly state upfront within manuscript that they are following such guidelines within their protocol reporting, and that they in turn plan as part of the protocol to utilize an appropriate reporting guideline when preparing to share their results. It is suggest that a supplementary explicit statement is included, potentially within the last paragraph of the Introduction, that the subsequent protocol reporting is consistent with the SPIRIT 2013 checklist: ‘This article presents, following the SPIRIT 2013 framework criteria (https://www.spirit-statement.org/), the protocol for…’ (or similar to convey intent to reader; alternatively such a statement may be what leads off the Methodology / Protocol outlining section).

It is noted on page 8 that there is a Reporting guideline heading, and that a link is provided to another document, which is a completed but unlabelled SPIRIT checklist; however there are no identifying information to link that checklist to this protocol, and in fact the supplied page numbers (1-13) within that completed checklist do not align to this protocol reporting of 9 pages. Furthermore, within this completed checklist there are a number of criteria that are marked as ‘N/A’, without explanation – it is not clear for this reviewer why it would be considered that criteria 11b-d, 17a-b, 23, 27, 29, & 30 of the SPIRIT 2013 checklist are judged to be not applicable for addressing within this protocol reporting – this warrants commentary by authors.

The following specific comments are offered for author consideration:

Page 3 of 10

Introduction, paragraph 1, line 8 – suggest amending to utilize previously defined abbreviation ‘…of the VSD.’

Introduction, paragraph 2, citations 8-14 discussed here all pertain to traditional cardiac surgeries associated with coronary artery disease or valvular dysfunction – the demographics and comorbidities of participants of such studies are vastly different to those being targeted in this current project. Whilst VSD repair is technically under the umbrella of cardiac surgery, it is somewhat misleading to reader to attribute such literature findings (of citations 8-14) to those having corrective surgery for congenital heart defects in their adolescence. Authors need to tailor this background context / synthesis to be of the relevant knowledge from the paediatric and/or adolescent cardiac surgery literature (even if it is limited). At the very least authors should acknowledge that there is limited external validity of existing adult literature to be translatable to the study cohort, and why.

Introduction, paragraph 3 – similarly this paragraph & its citation is only relevant to adults – citation 15 included only subjects >18 years of age & from the 8 included studies 7 were coronary artery bypass cohorts only, with the 8^th a mixed cohort of mitral valve and coronary artery surgery case, and the gross average age across all these studies was 63 years and with a predominance of males. So the interventions and interventions presented are not necessarily aligned to the cohort of this project. It is acknowledged though by authors that there is limited literature but they don’t then extend to share any insights to what is the current incidence of post-operative complications in the adolescent VSD surgery cohort, what the current post-op physical therapy interventions consist of, what the use / role of IMT may be in the adolescent cohort more broadly?

However more recent citations on same topic may have been more appropriate/relevant to have included? (albeit with same limitations – why did authors pin their sentiments against only #15)??

Cordeiro, A. L. L., Soares, L. O., Gomes-Neto, M., & Petto, J. (2023). Inspiratory muscle training in patients in the postoperative phase of cardiac surgery: a systematic review and meta-analysis. Annals of rehabilitation medicine, 47(3), 162–172. https://doi.org/10.5535/arm.23022
Xiang, Y., Zhao, Q., Luo, T., & Zeng, L. (2023). Inspiratory muscle training to reduce risk of pulmonary complications after coronary artery bypass grafting: a systematic review and meta-analysis. Frontiers in cardiovascular medicine, 10, 1223619. https://doi.org/10.3389/fcvm.2023.1223619
Dsouza, F. V., Amaravadi, S. K., Samuel, S. R., Raghavan, H., & Ravishankar, N. (2021). Effectiveness of inspiratory muscle training on respiratory muscle strength in patients undergoing cardiac surgeries: a systematic review with meta-analysis. Annals of Rehabilitation Medicine, 45(4), 264–273. https://doi.org/10.5535/arm.21027
Kendall, F., Oliveira, J., Peleteiro, B., Pinho, P., & Bastos, P. T. (2018). Inspiratory muscle training is effective to reduce postoperative pulmonary complications and length of hospital stay: a systematic review and meta-analysis. Disability and rehabilitation, 40(8), 864–882. https://doi.org/10.1080/09638288.2016.1277396
Thybo Karanfil, E. O., & Møller, A. M. (2018). Preoperative inspiratory muscle training prevents pulmonary complications after cardiac surgery - a systematic review. Danish medical journal, 65(3), A5450.

Introduction, paragraph 5, line 2 – suggest either correct typographical error (PowerBrethe) or more preferentially, amending to utilize previously defined abbreviation ‘…the PwB medic...’

Page 4 of 10

Ethics and consent – authors have stated that study will be conducted with written informed consent from all participants; as participants are children/adolescents it is not clear here if the consent is from these minors and/or whether parental / carer / legal guardian consent is also provided. It is also not explicit as to whether this consent is obtained pre-operatively or post-operatively. Suggest supplementary information be included here to clarify. (It is only within criteria 4 of inclusion criteria [page 5] that it becomes evident that in fact it is parental consent, not participant consent, that is required.

Trial design – is this really a RCT?? Both groups receive intervention involving IMT, just with different devices – there is no true control group or a standard comparator group (as IMT is not standard care in the chosen cohort). Commonly accepted convention is that the term “controlled” refers to the presence of a concurrent control or comparator group. Such studies have two or more groups – intervention and control. The control group receives no intervention, or another intervention that resembles the test intervention in some ways but lacks its activity (e.g., placebo or sham procedure, also referred to as “placebo-controlled” or “sham-controlled” trials) or another active treatment (e.g., the current standard of care). In this reporting, the standard care is not clearly outlined and within the protocol the variance between groups is insufficient, as it is the device to deliver the intervention (of IMT) that is the only difference and fundamentally the structure and prescription of the intervention in both groups is otherwise identical.
If one does weight training of say biceps curls of 6 sets of 5 reps @ 40% of the 1RM, is not the training load the same whether using a bag of sand or a bag of sugar to provide the weight? Would one reasonable expect that performing the same task via the same prescription parameters produce the same impact on chosen outcome measures? The comparator difference between sand and sugar would be hard to substantiate.
So then how do the authors hypothesize / propose that delivering IMT with the same training intensity, either with PowerBreathe or threshold devices, both acknowledged as pressure loaded devices, would perform differently and produce dissimilar outcomes? Authors have not provided any rationale as to how or why the two chosen devices would function any differently to deliver the desired IMT as prescribed.

No research question or hypotheses are offered by the authors within their protocol, although aims and objectives are shared. It would have been reasonable to have expected that a research protocol paper would include an overt hypothesis or research question.

The rationale to undertake this protocol is insufficiently prosecuted by the authors. Whilst authors acknowledge that research on physical therapy in those undergoing VSD closure surgery is limited, it is not established what current physical therapy practice is, whether current practice is effective, efficient, safe etc, or whether there are concerns that current practice may be associated with sub-optimal outcomes. Similarly, the justification for respiratory muscle training to be an adjunct or alternative strategy to usual/current/standard practice is not made. What is the problem (& its magnitude/significance) the anticipated findings from this project are hoping to address? Finally, the differentiation between two devices utilized to provide respiratory muscle training (PowerBreathe & Threshold devices) is insufficiently clear for the reader to appreciate why one may be preferrable over the other in the clinical cohort being studied. The authors fail to answer for the reader the fundamental ‘Why?’ and ‘So what?’ questions to substantiate the putting together of their research protocol…

Page 4 of 10

Participants and recruitment, paragraph 1 – there is insufficient detail to allay concerns of potential selection / inclusion bias.
What does ‘The inclusion and exclusion criteria for selection will be based on the cut-off values at baseline parameters when engaging participants’ actually mean? What baseline parameters, and what are the associated cut-off parameters?
What is the rationale for a six-month recruitment phase? How does this relate/intercede with the sample size calculation provided on page 6?

Page 5 of 10

Group information – as per comments above, the descriptors provided here for experimental and ‘control’ group interventions are identical in all parameters of the prescription framework (frequency, intensity, type, time, volume & progression), with the only difference being the piece of equipment used to provide the IMT; but both devices provide pressure loading, so what is really considered to be a stimulus for a differential response is not apparent.

What physical therapy occurs before POD-3? Suggest some comments around this are included.
What is the post-operative mobility program? When does ambulation commence? Is there a structured approach to post-operative mobility? Are there any restrictions to post-operative mobility, return to physical activity and/or sports? Would it be anticipated that the participants may return to schooling, or work, before data collection has been completed? There is no commentary within the protocol as to the standardization of ambulation, or even the recording of ambulation (frequency, distance, milestones, etc) or physical activity levels more broadly across the 7 weeks (4 weeks intervention & 3 weeks to final follow up) to be able to assess if this may be a confounder to the outcome measures. It is recommended that the authors may need to supplement the reporting of their protocol to address such potential confounders.

It is not clear what position the intervention will be performed in – will participants be standing or sitting for the IMT? If sitting, will it be supported sitting in a chair, or long sitting in bed/ on a plinth, or sitting unsupported over the edge of a bed/plinth?
Will the IMT be delivered via a mouthpiece or via a mask (or will participants get to choose?). Will the IMT intervention (& conservative physical therapy management) be directly conducted by a therapist/researcher, or independently performed but under a form of supervision (i.e. participant is conducting the IMT within a hospital gym / ambulatory care setting, potentially in a group based scenario?

When will participants be anticipated to be discharged from hospital after their surgery? It would presumably not be expected for them to stay admitted for the 4 weeks of the study, but regardless they are expected to return to the hospital twice daily to receive the intervention for the 4 weeks? Is this feasible, particularly as these are children/adolescents? Does this then create an inclusion bias such that anyone who resides not close to the hospital, and returns home after the surgery and thus unable to travel back to the hospital twice daily, will be excluded?

What will be considered compliance with the intervention? If the intervention is prescribed as twice daily, every day for a 4-week period, then that is a total of 56 sessions – how many can be missed before a participant is withdrawn or considered ‘non-compliant’?
Will researchers be recording attendance/ session completion data? How will any missed sessions or missed data be managed within the protocol is not described.

Page 6 of 10

Outcomes – who is planned to perform the assessment of the outcome measures? Will they be blinded to group allocation and independent to study objectives? Will this be a standardized, trained individual or a team of assessors? This should be clear for the reader, and to allow for repeatability and external validity considerations.
What procedure will be followed to gather the MIP? Will subjects perform in sitting or standing etc? Again it is suggested that further details be included to assist clarity.
Similarly, how will the 6MWT be conducted – indoors vs outdoors? Circular track vs point to point ? etc

– suggest provide a supporting citation for procedure to be followed in this project (such as Holland, A. E., Spruit, M. A., Troosters, T., Puhan, M. A., Pepin, V., Saey, D., McCormack, M. C., Carlin, B. W., Sciurba, F. C., Pitta, F., Wanger, J., MacIntyre, N., Kaminsky, D. A., Culver, B. H., Revill, S. M., Hernandes, N. A., Andrianopoulos, V., Camillo, C. A., Mitchell, K. E., Lee, A. L., … Singh, S. J. (2014). An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. The European respiratory journal, 44(6), 1428–1446. https://doi.org/10.1183/09031936.00150314)

And same query on the conduct of the PFTs – suggest provision of a citation of the procedure/guideline to be followed in the conduct and interpretation of this outcome measure (e.g. Graham BL, Steenbruggen I, Miller MR, et al. Standardization of spirometry 2019 update. An official American Thoracic Society and European Respiratory Society technical statement. Am J Respir Crit Care Med 2019; 200: e70–e88. doi:10.1164/rccm.201908-1590ST
Stanojevic, S., Kaminsky, D. A., Miller, M. R., Thompson, B., Aliverti, A., Barjaktarevic, I., Cooper, B. G., Culver, B., Derom, E., Hall, G. L., Hallstrand, T. S., Leuppi, J. D., MacIntyre, N., McCormack, M., Rosenfeld, M., & Swenson, E. R. (2022). ERS/ATS technical standard on interpretive strategies for routine lung function tests. The European respiratory journal, 60(1), 2101499. https://doi.org/10.1183/13993003.01499-2021)

No metrics of participant satisfaction, costs, device logistics (durability, cleanliness, ease of use, etc) are proposed to be captured. In a study which ultimately is simply comparing two devices delivering the same intervention (in the doses prescribed within the studied cohort), surely such parameters are required to be able to inform future consumers (and clinicians & researchers) as to which device may be preferable to pursue? Or are the authors anticipating a non-inferiority finding, and then being able to simply offer future patients a choice between devices to deliver any proposed IMT?

Page 7 of 10

‘Data collection, management and analysis’ is evident as a single line statement, but there are no paragraphs on data collection or management prior to details shared under an Analysis heading. As a protocol paper it would be expected that the specificity of the plans for data collection methods and data management be explicitly outlined for transparency and accountability (as per the SPIRIT checklist).

Analysis, line 1 -firstly ‘R studio’ is an editor (Integrated Development Environment), whilst ‘R’ (the software package) is what is used to do the analysis. It is suspected the author intentions are to use ‘R’.
Suggest amending/supplementing to provide citation for the R software ' …using R software (Version 4.3.0 released April 2023) [R Core Team (2023). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/.]'
(NB authors please check the accurate version number you plan to use and reference accordingly, as already it is up to 4.3.2 as of 31^st Oct 2023)

Line 2 – correct typographical error ‘nanalysed’

Discussion

It is unclear to this reviewer what the intent of the current structure of the Discussion is; information presented here could easily sit instead within the context of the Introduction background/context aiding synthesis of existing knowledge and providing justification for this project and its protocol design.
Whilst not imperative to have a Discussion within a protocol paper, if one is to be included then one may reasonable expect that the discussion aligns to aspects of the implementation of the proposed protocol – discussion around feasibility issues (anticipated or unanticipated), possible barriers to study conduct and proposed strategies to avoid and/or ameliorate, expected outcomes of the study - the protocol should indicate how the study will contribute to advancement of knowledge, how the results will be utilized, not only in publications but also how they will likely affect health care, health systems, or health policies.

Dissemination of results and publication policy should also feature (either within Discussion, or as unique sections)– whilst it is acknowledged that authors have included a Dissemination statement (on page 8), this has been targeted only at the protocol & findings being presented in conference proceedings. “The protocol should specify not only dissemination of results in the scientific media, but also to the community and/ or the participants, and consider dissemination to the policy makers where relevant. Publication policy should be clearly discussed- for example who will take the lead in publication and who will be acknowledged in publications, etc.” (https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol)

Page 8 of 10

What are the plans for data monitoring and auditing within this project? What is being used to define what constitutes an ‘adverse event’? Who will adverse events be reported to?

There are no details within the protocol reporting as to confidentiality, deidentification of data, plans for data storage and accessibility (post study) -the Data availability heading correctly states that there are no data presently, but the protocol needs to address how the incoming data will be managed…

References

Suggest reference list needs to be reviewed for consistency of style of capitalization of article titles.

#18 – needs to be completed with correct full citation details: Menzes KKP, Nascimento LR, Avelino PR, Polese JC, Salmela LFT (2018) A review on respiratory muscle training devices . J Pulm Respir Med 8:451. doi: 10.4172/2161-105X.1000451

In a submission on this topic, other potentially relevant articles such as those listed below (non-exhaustive and non-prioritized listing) may have been pertinent and valuable inclusions within the Introduction and/or Discussion??(accepting they are not necessarily IMT focused, but more related to this study cohort and current practice)

Turquetto, A. L. R., Dos Santos, M. R., Agostinho, D. R., Sayegh, A. L. C., de Souza, F. R., Amato, L. P., Barnabe, M. S. R., de Oliveira, P. A., Liberato, G., Binotto, M. A., Negrão, C. E., Canêo, L. F., Trindade, E., Jatene, F. B., & Jatene, M. B. (2021). Aerobic exercise and inspiratory muscle training increase functional capacity in patients with univentricular physiology after Fontan operation: A randomized controlled trial. International journal of cardiology, 330, 50–58. https://doi.org/10.1016/j.ijcard.2021.01.058
Wu, F. M., Opotowsky, A. R., Denhoff, E. R., Gongwer, R., Gurvitz, M. Z., Landzberg, M. J., Shafer, K. M., Valente, A. M., Uluer, A. Z., & Rhodes, J. (2018). A pilot study of inspiratory muscle training to improve exercise capacity in patients with fontan physiology. Seminars in thoracic and cardiovascular surgery, 30(4), 462–469. https://doi.org/10.1053/j.semtcvs.2018.07.014
Abdulkarim, A., Shaji, S., Elfituri, M., Gunsaulus, M., Zafar, M. A., Zaidi, A. N., Pass, R. H., Feingold, B., Kurland, G., Kreutzer, J., Ghassemzadeh, R., Goldstein, B., West, S., & Alsaied, T. (2023). Pulmonary complications in patients with fontan circulation: JACC Review Topic of the Week. Journal of the American College of Cardiology, 81(25), 2434–2444. https://doi.org/10.1016/j.jacc.2023.04.036
Scheffers, L. E., Berg, L. E. M. V., Ismailova, G., Dulfer, K., Takkenberg, J. J. M., & Helbing, W. A. (2021). Physical exercise training in patients with a Fontan circulation: A systematic review. European journal of preventive cardiology, 28(11), 1269–1278. https://doi.org/10.1177/2047487320942869
Ferrer-Sargues, F. J., Peiró-Molina, E., Salvador-Coloma, P., Carrasco Moreno, J. I., Cano-Sánchez, A., Vázquez-Arce, M. I., Insa Albert, B., Sepulveda Sanchis, P., & Cebrià i Iranzo, M. À. (2020). Cardiopulmonary rehabilitation improves respiratory muscle function and functional capacity in children with congenital heart disease. A prospective cohort study. International Journal of Environmental Research and Public Health, 17(12), 4328–. https://doi.org/10.3390/ijerph17124328
McBride MG, Burstein DS, Edelson JB, Paridon SM. Cardiopulmonary rehabilitation in pediatric patients with congenital and acquired heart disease. J Cardiopulm Rehabil Prev. 2020;40(6):370–377.
Gauthier N, Curran T, O’Neill JA, Alexander ME, Rhodes J. Establishing a comprehensive pediatric cardiac fitness and rehabilitation program for congenital heart disease. Pediatr Cardiol. 2020;41(8):1569–1579..
Akamagwuna U, Badaly D. Pediatric cardiac rehabilitation: a review. Curr Phys Med Rehabil Rep. 2019;7(2):67-80. doi:10.1007/s40141-019-00216-9.
Longmuir PE, Brothers JA, de Ferranti SD, et al. Promotion of physical activity for children and adults with congenital heart disease: a scientific statement from the American Heart Association. Circulation. 2013;127(21):2147–2159.
Tikkanen AU, Oyaga AR, Riaño OA, Álvaro EM, Rhodes J. Paediatric cardiac rehabilitation in congenital heart disease: a systematic review. Cardiol Young. 2012;22(3):241–250
Duppen, N., Etnel, J. R., Spaans, L., Takken, T., van den Berg-Emons, R. J., Boersma, E., Schokking, M., Dulfer, K., Utens, E. M., Helbing, W., & Hopman, M. T. (2015). Does exercise training improve cardiopulmonary fitness and daily physical activity in children and young adults with corrected tetralogy of Fallot or Fontan circulation? A randomized controlled trial. The American Heart Journal, 170(3), 606–614. https://doi.org/10.1016/j.ahj.2015.06.018
Clarke, S. L., Milburn, N. C., Menzies, J. C., & Drury, N. E. (2023). The provision and impact of rehabilitation provided by Physiotherapists in children and young people with congenital heart disease following cardiac surgery: A scoping review. Physiotherapy. https://doi.org/10.1016/j.physio.2023.09.001
Beningfield, A., & Jones, A. (2018). Peri-operative chest physiotherapy for paediatric cardiac patients: a systematic review and meta-analysis. Physiotherapy, 104(3), 251–263. https://doi.org/10.1016/j.physio.2017.08.011
Gauthier, N., Curran, T., O’Neill, J. A., Alexander, M. E., & Rhodes, J. (2020). Establishing a comprehensive pediatric cardiac fitness and rehabilitation program for congenital heart disease. pediatric Cardiology, 41(8), 1569–1579. https://doi.org/10.1007/s00246-020-02413-z
Tran, D., Maiorana, A., Ayer, J., Lubans, D. R., Davis, G. M., Celermajer, D. S., d'Udekem, Y., & Cordina, R. (2020). Recommendations for exercise in adolescents and adults with congenital heart disease. Progress in cardiovascular diseases, 63(3), 350–366. https://doi.org/10.1016/j.pcad.2020.03.002

Finally this reviewer is reminded of the following publication and musing of its relevance and message when considering this protocol:

Illidi, C. R., Romer, L. M., Johnson, M. A., Williams, N. C., Rossiter, H. B., Casaburi, R., & Tiller, N. B. (2023). Distinguishing science from pseudoscience in commercial respiratory interventions: an evidence-based guide for health and exercise professionals. European journal of applied physiology, 123(8), 1599–1625. https://doi.org/10.1007/s00421-023-05166-8

The authors would do well to avoid such concerns potentially being within readers' perceptions by providing further details supporting their rationale and justification for their chosen study design and methodology protocol.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Yau DKW, Underwood MJ, Joynt GM, Lee A: Effect of preparative rehabilitation on recovery after cardiac surgery: A systematic review.Ann Phys Rehabil Med. 2021; 64 (2): 101391 PubMed Abstract | Publisher Full Text
2. Steinmetz C, Bjarnason-Wehrens B, Walther T, Schaffland TF, et al.: Efficacy of Prehabilitation Before Cardiac Surgery: A Systematic Review and Meta-analysis.Am J Phys Med Rehabil. 2023; 102 (4): 323-330 PubMed Abstract | Publisher Full Text
3. Olsen DB, Pedersen PU, Noergaard MW: Prehabilitation before elective coronary artery bypass grafting surgery: a scoping review.JBI Evid Synth. 2023; 21 (6): 1190-1242 PubMed Abstract | Publisher Full Text
4. Assouline B, Cools E, Schorer R, Kayser B, et al.: Preoperative Exercise Training to Prevent Postoperative Pulmonary Complications in Adults Undergoing Major Surgery. A Systematic Review and Meta-analysis with Trial Sequential Analysis.Ann Am Thorac Soc. 2021; 18 (4): 678-688 PubMed Abstract | Publisher Full Text
5. Gibbison B, Murphy GJ, Akowuah E, Loubani M, et al.: Pre-operative and prehabilitation services in UK cardiac surgery centres.Anaesthesia. 2023; 78 (3): 388-391 PubMed Abstract | Publisher Full Text
6. Katsura M, Kuriyama A, Takeshima T, Fukuhara S, et al.: Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery.Cochrane Database Syst Rev. 2015; 2015 (10): CD010356 PubMed Abstract | Publisher Full Text
7. Kendall F, Oliveira J, Peleteiro B, Pinho P, et al.: Inspiratory muscle training is effective to reduce postoperative pulmonary complications and length of hospital stay: a systematic review and meta-analysis.Disabil Rehabil. 2018; 40 (8): 864-882 PubMed Abstract | Publisher Full Text
8. Noronha J, Samuel S, Singh V, Prabhu H: Effects of exercise-based prehabilitation in children undergoing elective surgeries: a systematic review. F1000Research. 2022; 10. Publisher Full Text
9. Cordeiro ALL, Soares LO, Gomes-Neto M, Petto J: Inspiratory Muscle Training in Patients in the Postoperative Phase of Cardiac Surgery: A Systematic Review and Meta-Analysis.Ann Rehabil Med. 2023; 47 (3): 162-172 PubMed Abstract | Publisher Full Text
10. Xiang Y, Zhao Q, Luo T, Zeng L: Inspiratory muscle training to reduce risk of pulmonary complications after coronary artery bypass grafting: a systematic review and meta-analysis.Front Cardiovasc Med. 2023; 10: 1223619 PubMed Abstract | Publisher Full Text
11. Dsouza FV, Amaravadi SK, Samuel SR, Raghavan H, et al.: Effectiveness of Inspiratory Muscle Training on Respiratory Muscle Strength in Patients Undergoing Cardiac Surgeries: A Systematic Review With Meta-Analysis.Ann Rehabil Med. 2021; 45 (4): 264-273 PubMed Abstract | Publisher Full Text
12. Thybo Karanfil EO, Møller AM: Preoperative inspiratory muscle training prevents pulmonary complications after cardiac surgery - a systematic review.Dan Med J. 2018; 65 (3). PubMed Abstract
13. Holland AE, Spruit MA, Troosters T, Puhan MA, et al.: An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease.Eur Respir J. 2014; 44 (6): 1428-46 PubMed Abstract | Publisher Full Text
14. Turquetto ALR, Dos Santos MR, Agostinho DR, Sayegh ALC, et al.: Aerobic exercise and inspiratory muscle training increase functional capacity in patients with univentricular physiology after Fontan operation: A randomized controlled trial.Int J Cardiol. 2021; 330: 50-58 PubMed Abstract | Publisher Full Text
15. Wu F, Opotowsky A, Denhoff E, Gongwer R, et al.: A Pilot Study of Inspiratory Muscle Training to Improve Exercise Capacity in Patients with Fontan Physiology. Seminars in Thoracic and Cardiovascular Surgery. 2018; 30 (4): 462-469 Publisher Full Text
16. Abdulkarim A, Shaji S, Elfituri M, Gunsaulus M, et al.: Pulmonary Complications in Patients With Fontan Circulation: JACC Review Topic of the Week.J Am Coll Cardiol. 2023; 81 (25): 2434-2444 PubMed Abstract | Publisher Full Text
17. Scheffers LE, Berg LEMV, Ismailova G, Dulfer K, et al.: Physical exercise training in patients with a Fontan circulation: A systematic review.Eur J Prev Cardiol. 2021; 28 (11): 1269-1278 PubMed Abstract | Publisher Full Text
18. Ferrer-Sargues FJ, Peiró-Molina E, Salvador-Coloma P, Carrasco Moreno JI, et al.: Cardiopulmonary Rehabilitation Improves Respiratory Muscle Function and Functional Capacity in Children with Congenital Heart Disease. A Prospective Cohort Study.Int J Environ Res Public Health. 2020; 17 (12). PubMed Abstract | Publisher Full Text
19. McBride MG, Burstein DS, Edelson JB, Paridon SM: Cardiopulmonary Rehabilitation in Pediatric Patients With Congenital and Acquired Heart Disease.J Cardiopulm Rehabil Prev. 2020; 40 (6): 370-377 PubMed Abstract | Publisher Full Text
20. Gauthier N, Curran T, O'Neill JA, Alexander ME, et al.: Establishing a Comprehensive Pediatric Cardiac Fitness and Rehabilitation Program for Congenital Heart Disease.Pediatr Cardiol. 2020; 41 (8): 1569-1579 PubMed Abstract | Publisher Full Text
21. Akamagwuna U, Badaly D: Pediatric Cardiac Rehabilitation: a Review. Current Physical Medicine and Rehabilitation Reports. 2019; 7 (2): 67-80 Publisher Full Text
22. Longmuir P, Brothers J, de Ferranti S, Hayman L, et al.: Promotion of Physical Activity for Children and Adults With Congenital Heart Disease. Circulation. 2013; 127 (21): 2147-2159 Publisher Full Text
23. Tikkanen AU, Oyaga AR, Riaño OA, Álvaro EM, et al.: Paediatric cardiac rehabilitation in congenital heart disease: a systematic review.Cardiol Young. 2012; 22 (3): 241-50 PubMed Abstract | Publisher Full Text
24. Duppen N, Etnel JR, Spaans L, Takken T, et al.: Does exercise training improve cardiopulmonary fitness and daily physical activity in children and young adults with corrected tetralogy of Fallot or Fontan circulation? A randomized controlled trial.Am Heart J. 2015; 170 (3): 606-14 PubMed Abstract | Publisher Full Text
25. Clarke S, Milburn N, Menzies J, Drury N: The provision and impact of rehabilitation provided by Physiotherapists in children and young people with congenital heart disease following cardiac surgery: A scoping review. Physiotherapy. 2023. Publisher Full Text
26. Beningfield A, Jones A: Peri-operative chest physiotherapy for paediatric cardiac patients: a systematic review and meta-analysis.Physiotherapy. 2018; 104 (3): 251-263 PubMed Abstract | Publisher Full Text
27. Tran D, Maiorana A, Ayer J, Lubans DR, et al.: Recommendations for exercise in adolescents and adults with congenital heart disease.Prog Cardiovasc Dis. 2020; 63 (3): 350-366 PubMed Abstract | Publisher Full Text
28. Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, et al.: Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement.Am J Respir Crit Care Med. 2019; 200 (8): e70-e88 PubMed Abstract | Publisher Full Text
29. Stanojevic S, Kaminsky DA, Miller MR, Thompson B, et al.: ERS/ATS technical standard on interpretive strategies for routine lung function tests.Eur Respir J. 2022; 60 (1). PubMed Abstract | Publisher Full Text
30. Illidi CR, Romer LM, Johnson MA, Williams NC, et al.: Distinguishing science from pseudoscience in commercial respiratory interventions: an evidence-based guide for health and exercise professionals.Eur J Appl Physiol. 2023; 123 (8): 1599-1625 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Critical care; acute care; rehabilitation; physical therapy; respiratory care

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Shane Patman, The University of Notre Dame Australia, Perth, Australia

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08 Nov 2023 | for Version 1

Shane Patman, Faculty of Medicine, Nursing and Midwifery, and Health Sciences, The University of Notre Dame Australia, Perth, Australia

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Approved With Reservations

Many thanks for the opportunity to contribute to the peer review process for the study protocol within F1000Research entitled 'Effect of Powerbreath Medic Plus versus Threshold IMT on maximal inspiratory pressure and functional capacity in postoperative ventricular septal defect closure: A protocol for a randomized controlled trial'

General Comments

Suggest rephrasing throughout submission to avoid starting sentences with abbreviations or numbers (e.g. such as: Abstract, Background, line 4; Abstract, Method, line 6; Introduction, paragraph 1, line 2; Introduction, paragraph 4, line 1)

Suggest amending to depersonalize throughout submission (e.g. such as: Abstract, Method, line 1 ; Abstract, Predicted results, line 3)

The role of prehabilitation, some programs inclusive of the use of IMT, is a growing topic within contemporary literature within the adult major surgery cohorts (such as those listed below). It may be prudent for authors to acknowledge this topic and for them to comment as to why they are choosing to focus solely on the post-operative use of IMT in isolation for their project.

Yau, D. K. W., Underwood, M. J., Joynt, G. M., & Lee, A. (2021). Effect of preparative rehabilitation on recovery after cardiac surgery: A systematic review. Annals of physical and rehabilitation medicine, 64(2), 101391. https://doi.org/10.1016/j.rehab.2020.03.014
Steinmetz, C., Bjarnason-Wehrens, B., Walther, T., Schaffland, T. F., & Walther, C. (2023). Efficacy of Prehabilitation Before Cardiac Surgery: A Systematic Review and Meta-analysis. American journal of physical medicine & rehabilitation, 102(4), 323–330. https://doi.org/10.1097/PHM.0000000000002097
Olsen, D. B., Pedersen, P. U., & Noergaard, M. W. (2023). Prehabilitation before elective coronary artery bypass grafting surgery: a scoping review. JBI evidence synthesis, 21(6), 1190–1242. https://doi.org/10.11124/JBIES-22-00265
Assouline, B., Cools, E., Schorer, R., Kayser, B., Elia, N., & Licker, M. (2021). Preoperative Exercise Training to Prevent Postoperative Pulmonary Complications in Adults Undergoing Major Surgery. A Systematic Review and Meta-analysis with Trial Sequential Analysis. Annals of the American Thoracic Society, 18(4), 678–688. https://doi.org/10.1513/AnnalsATS.202002-183OC
Gibbison, B., Murphy, G. J., Akowuah, E., Loubani, M., & Pufulete, M. (2023). Pre-operative and prehabilitation services in UK cardiac surgery centres. Anaesthesia, 78(3), 388–391. https://doi.org/10.1111/anae.15918
Katsura, M., Kuriyama, A., Takeshima, T., Fukuhara, S., & Furukawa, T. A. (2015). Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. The Cochrane database of systematic reviews, 2015(10), CD010356. https://doi.org/10.1002/14651858.CD010356.pub2
Kendall, F., Oliveira, J., Peleteiro, B., Pinho, P., & Bastos, P. T. (2018). Inspiratory muscle training is effective to reduce postoperative pulmonary complications and length of hospital stay: a systematic review and meta-analysis. Disability and rehabilitation, 40(8), 864–882. https://doi.org/10.1080/09638288.2016.1277396
Noronha, J., Samuel, S., Singh, V. P., & Prabhu, H. S. (2022). Effects of exercise-based prehabilitation in children undergoing elective surgeries: a systematic review. F1000Research, 10, 1262. https://doi.org/10.12688/f1000research.74493.2

No reporting guidelines / checklists for this protocol project reporting are explicitly stated as being followed (such as TIDieR, SPIRIT) - to enhance the quality and transparency of health research reporting, authors are strongly encouraged to explicitly state upfront within manuscript that they are following such guidelines within their protocol reporting, and that they in turn plan as part of the protocol to utilize an appropriate reporting guideline when preparing to share their results. It is suggest that a supplementary explicit statement is included, potentially within the last paragraph of the Introduction, that the subsequent protocol reporting is consistent with the SPIRIT 2013 checklist: ‘This article presents, following the SPIRIT 2013 framework criteria (https://www.spirit-statement.org/), the protocol for…’ (or similar to convey intent to reader; alternatively such a statement may be what leads off the Methodology / Protocol outlining section).

It is noted on page 8 that there is a Reporting guideline heading, and that a link is provided to another document, which is a completed but unlabelled SPIRIT checklist; however there are no identifying information to link that checklist to this protocol, and in fact the supplied page numbers (1-13) within that completed checklist do not align to this protocol reporting of 9 pages. Furthermore, within this completed checklist there are a number of criteria that are marked as ‘N/A’, without explanation – it is not clear for this reviewer why it would be considered that criteria 11b-d, 17a-b, 23, 27, 29, & 30 of the SPIRIT 2013 checklist are judged to be not applicable for addressing within this protocol reporting – this warrants commentary by authors.

The following specific comments are offered for author consideration:

Page 3 of 10

Introduction, paragraph 1, line 8 – suggest amending to utilize previously defined abbreviation ‘…of the VSD.’

Introduction, paragraph 2, citations 8-14 discussed here all pertain to traditional cardiac surgeries associated with coronary artery disease or valvular dysfunction – the demographics and comorbidities of participants of such studies are vastly different to those being targeted in this current project. Whilst VSD repair is technically under the umbrella of cardiac surgery, it is somewhat misleading to reader to attribute such literature findings (of citations 8-14) to those having corrective surgery for congenital heart defects in their adolescence. Authors need to tailor this background context / synthesis to be of the relevant knowledge from the paediatric and/or adolescent cardiac surgery literature (even if it is limited). At the very least authors should acknowledge that there is limited external validity of existing adult literature to be translatable to the study cohort, and why.

Introduction, paragraph 3 – similarly this paragraph & its citation is only relevant to adults – citation 15 included only subjects >18 years of age & from the 8 included studies 7 were coronary artery bypass cohorts only, with the 8^th a mixed cohort of mitral valve and coronary artery surgery case, and the gross average age across all these studies was 63 years and with a predominance of males. So the interventions and interventions presented are not necessarily aligned to the cohort of this project. It is acknowledged though by authors that there is limited literature but they don’t then extend to share any insights to what is the current incidence of post-operative complications in the adolescent VSD surgery cohort, what the current post-op physical therapy interventions consist of, what the use / role of IMT may be in the adolescent cohort more broadly?

However more recent citations on same topic may have been more appropriate/relevant to have included? (albeit with same limitations – why did authors pin their sentiments against only #15)??

Cordeiro, A. L. L., Soares, L. O., Gomes-Neto, M., & Petto, J. (2023). Inspiratory muscle training in patients in the postoperative phase of cardiac surgery: a systematic review and meta-analysis. Annals of rehabilitation medicine, 47(3), 162–172. https://doi.org/10.5535/arm.23022
Xiang, Y., Zhao, Q., Luo, T., & Zeng, L. (2023). Inspiratory muscle training to reduce risk of pulmonary complications after coronary artery bypass grafting: a systematic review and meta-analysis. Frontiers in cardiovascular medicine, 10, 1223619. https://doi.org/10.3389/fcvm.2023.1223619
Dsouza, F. V., Amaravadi, S. K., Samuel, S. R., Raghavan, H., & Ravishankar, N. (2021). Effectiveness of inspiratory muscle training on respiratory muscle strength in patients undergoing cardiac surgeries: a systematic review with meta-analysis. Annals of Rehabilitation Medicine, 45(4), 264–273. https://doi.org/10.5535/arm.21027
Kendall, F., Oliveira, J., Peleteiro, B., Pinho, P., & Bastos, P. T. (2018). Inspiratory muscle training is effective to reduce postoperative pulmonary complications and length of hospital stay: a systematic review and meta-analysis. Disability and rehabilitation, 40(8), 864–882. https://doi.org/10.1080/09638288.2016.1277396
Thybo Karanfil, E. O., & Møller, A. M. (2018). Preoperative inspiratory muscle training prevents pulmonary complications after cardiac surgery - a systematic review. Danish medical journal, 65(3), A5450.

Introduction, paragraph 5, line 2 – suggest either correct typographical error (PowerBrethe) or more preferentially, amending to utilize previously defined abbreviation ‘…the PwB medic...’

Page 4 of 10

Ethics and consent – authors have stated that study will be conducted with written informed consent from all participants; as participants are children/adolescents it is not clear here if the consent is from these minors and/or whether parental / carer / legal guardian consent is also provided. It is also not explicit as to whether this consent is obtained pre-operatively or post-operatively. Suggest supplementary information be included here to clarify. (It is only within criteria 4 of inclusion criteria [page 5] that it becomes evident that in fact it is parental consent, not participant consent, that is required.

Trial design – is this really a RCT?? Both groups receive intervention involving IMT, just with different devices – there is no true control group or a standard comparator group (as IMT is not standard care in the chosen cohort). Commonly accepted convention is that the term “controlled” refers to the presence of a concurrent control or comparator group. Such studies have two or more groups – intervention and control. The control group receives no intervention, or another intervention that resembles the test intervention in some ways but lacks its activity (e.g., placebo or sham procedure, also referred to as “placebo-controlled” or “sham-controlled” trials) or another active treatment (e.g., the current standard of care). In this reporting, the standard care is not clearly outlined and within the protocol the variance between groups is insufficient, as it is the device to deliver the intervention (of IMT) that is the only difference and fundamentally the structure and prescription of the intervention in both groups is otherwise identical.
If one does weight training of say biceps curls of 6 sets of 5 reps @ 40% of the 1RM, is not the training load the same whether using a bag of sand or a bag of sugar to provide the weight? Would one reasonable expect that performing the same task via the same prescription parameters produce the same impact on chosen outcome measures? The comparator difference between sand and sugar would be hard to substantiate.
So then how do the authors hypothesize / propose that delivering IMT with the same training intensity, either with PowerBreathe or threshold devices, both acknowledged as pressure loaded devices, would perform differently and produce dissimilar outcomes? Authors have not provided any rationale as to how or why the two chosen devices would function any differently to deliver the desired IMT as prescribed.

No research question or hypotheses are offered by the authors within their protocol, although aims and objectives are shared. It would have been reasonable to have expected that a research protocol paper would include an overt hypothesis or research question.

The rationale to undertake this protocol is insufficiently prosecuted by the authors. Whilst authors acknowledge that research on physical therapy in those undergoing VSD closure surgery is limited, it is not established what current physical therapy practice is, whether current practice is effective, efficient, safe etc, or whether there are concerns that current practice may be associated with sub-optimal outcomes. Similarly, the justification for respiratory muscle training to be an adjunct or alternative strategy to usual/current/standard practice is not made. What is the problem (& its magnitude/significance) the anticipated findings from this project are hoping to address? Finally, the differentiation between two devices utilized to provide respiratory muscle training (PowerBreathe & Threshold devices) is insufficiently clear for the reader to appreciate why one may be preferrable over the other in the clinical cohort being studied. The authors fail to answer for the reader the fundamental ‘Why?’ and ‘So what?’ questions to substantiate the putting together of their research protocol…

Page 4 of 10

Participants and recruitment, paragraph 1 – there is insufficient detail to allay concerns of potential selection / inclusion bias.
What does ‘The inclusion and exclusion criteria for selection will be based on the cut-off values at baseline parameters when engaging participants’ actually mean? What baseline parameters, and what are the associated cut-off parameters?
What is the rationale for a six-month recruitment phase? How does this relate/intercede with the sample size calculation provided on page 6?

Page 5 of 10

Group information – as per comments above, the descriptors provided here for experimental and ‘control’ group interventions are identical in all parameters of the prescription framework (frequency, intensity, type, time, volume & progression), with the only difference being the piece of equipment used to provide the IMT; but both devices provide pressure loading, so what is really considered to be a stimulus for a differential response is not apparent.

What physical therapy occurs before POD-3? Suggest some comments around this are included.
What is the post-operative mobility program? When does ambulation commence? Is there a structured approach to post-operative mobility? Are there any restrictions to post-operative mobility, return to physical activity and/or sports? Would it be anticipated that the participants may return to schooling, or work, before data collection has been completed? There is no commentary within the protocol as to the standardization of ambulation, or even the recording of ambulation (frequency, distance, milestones, etc) or physical activity levels more broadly across the 7 weeks (4 weeks intervention & 3 weeks to final follow up) to be able to assess if this may be a confounder to the outcome measures. It is recommended that the authors may need to supplement the reporting of their protocol to address such potential confounders.

It is not clear what position the intervention will be performed in – will participants be standing or sitting for the IMT? If sitting, will it be supported sitting in a chair, or long sitting in bed/ on a plinth, or sitting unsupported over the edge of a bed/plinth?
Will the IMT be delivered via a mouthpiece or via a mask (or will participants get to choose?). Will the IMT intervention (& conservative physical therapy management) be directly conducted by a therapist/researcher, or independently performed but under a form of supervision (i.e. participant is conducting the IMT within a hospital gym / ambulatory care setting, potentially in a group based scenario?

When will participants be anticipated to be discharged from hospital after their surgery? It would presumably not be expected for them to stay admitted for the 4 weeks of the study, but regardless they are expected to return to the hospital twice daily to receive the intervention for the 4 weeks? Is this feasible, particularly as these are children/adolescents? Does this then create an inclusion bias such that anyone who resides not close to the hospital, and returns home after the surgery and thus unable to travel back to the hospital twice daily, will be excluded?

What will be considered compliance with the intervention? If the intervention is prescribed as twice daily, every day for a 4-week period, then that is a total of 56 sessions – how many can be missed before a participant is withdrawn or considered ‘non-compliant’?
Will researchers be recording attendance/ session completion data? How will any missed sessions or missed data be managed within the protocol is not described.

Page 6 of 10

Outcomes – who is planned to perform the assessment of the outcome measures? Will they be blinded to group allocation and independent to study objectives? Will this be a standardized, trained individual or a team of assessors? This should be clear for the reader, and to allow for repeatability and external validity considerations.
What procedure will be followed to gather the MIP? Will subjects perform in sitting or standing etc? Again it is suggested that further details be included to assist clarity.
Similarly, how will the 6MWT be conducted – indoors vs outdoors? Circular track vs point to point ? etc

– suggest provide a supporting citation for procedure to be followed in this project (such as Holland, A. E., Spruit, M. A., Troosters, T., Puhan, M. A., Pepin, V., Saey, D., McCormack, M. C., Carlin, B. W., Sciurba, F. C., Pitta, F., Wanger, J., MacIntyre, N., Kaminsky, D. A., Culver, B. H., Revill, S. M., Hernandes, N. A., Andrianopoulos, V., Camillo, C. A., Mitchell, K. E., Lee, A. L., … Singh, S. J. (2014). An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. The European respiratory journal, 44(6), 1428–1446. https://doi.org/10.1183/09031936.00150314)

And same query on the conduct of the PFTs – suggest provision of a citation of the procedure/guideline to be followed in the conduct and interpretation of this outcome measure (e.g. Graham BL, Steenbruggen I, Miller MR, et al. Standardization of spirometry 2019 update. An official American Thoracic Society and European Respiratory Society technical statement. Am J Respir Crit Care Med 2019; 200: e70–e88. doi:10.1164/rccm.201908-1590ST
Stanojevic, S., Kaminsky, D. A., Miller, M. R., Thompson, B., Aliverti, A., Barjaktarevic, I., Cooper, B. G., Culver, B., Derom, E., Hall, G. L., Hallstrand, T. S., Leuppi, J. D., MacIntyre, N., McCormack, M., Rosenfeld, M., & Swenson, E. R. (2022). ERS/ATS technical standard on interpretive strategies for routine lung function tests. The European respiratory journal, 60(1), 2101499. https://doi.org/10.1183/13993003.01499-2021)

No metrics of participant satisfaction, costs, device logistics (durability, cleanliness, ease of use, etc) are proposed to be captured. In a study which ultimately is simply comparing two devices delivering the same intervention (in the doses prescribed within the studied cohort), surely such parameters are required to be able to inform future consumers (and clinicians & researchers) as to which device may be preferable to pursue? Or are the authors anticipating a non-inferiority finding, and then being able to simply offer future patients a choice between devices to deliver any proposed IMT?

Page 7 of 10

‘Data collection, management and analysis’ is evident as a single line statement, but there are no paragraphs on data collection or management prior to details shared under an Analysis heading. As a protocol paper it would be expected that the specificity of the plans for data collection methods and data management be explicitly outlined for transparency and accountability (as per the SPIRIT checklist).

Analysis, line 1 -firstly ‘R studio’ is an editor (Integrated Development Environment), whilst ‘R’ (the software package) is what is used to do the analysis. It is suspected the author intentions are to use ‘R’.
Suggest amending/supplementing to provide citation for the R software ' …using R software (Version 4.3.0 released April 2023) [R Core Team (2023). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/.]'
(NB authors please check the accurate version number you plan to use and reference accordingly, as already it is up to 4.3.2 as of 31^st Oct 2023)

Line 2 – correct typographical error ‘nanalysed’

Discussion

It is unclear to this reviewer what the intent of the current structure of the Discussion is; information presented here could easily sit instead within the context of the Introduction background/context aiding synthesis of existing knowledge and providing justification for this project and its protocol design.
Whilst not imperative to have a Discussion within a protocol paper, if one is to be included then one may reasonable expect that the discussion aligns to aspects of the implementation of the proposed protocol – discussion around feasibility issues (anticipated or unanticipated), possible barriers to study conduct and proposed strategies to avoid and/or ameliorate, expected outcomes of the study - the protocol should indicate how the study will contribute to advancement of knowledge, how the results will be utilized, not only in publications but also how they will likely affect health care, health systems, or health policies.

Dissemination of results and publication policy should also feature (either within Discussion, or as unique sections)– whilst it is acknowledged that authors have included a Dissemination statement (on page 8), this has been targeted only at the protocol & findings being presented in conference proceedings. “The protocol should specify not only dissemination of results in the scientific media, but also to the community and/ or the participants, and consider dissemination to the policy makers where relevant. Publication policy should be clearly discussed- for example who will take the lead in publication and who will be acknowledged in publications, etc.” (https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol)

Page 8 of 10

What are the plans for data monitoring and auditing within this project? What is being used to define what constitutes an ‘adverse event’? Who will adverse events be reported to?

There are no details within the protocol reporting as to confidentiality, deidentification of data, plans for data storage and accessibility (post study) -the Data availability heading correctly states that there are no data presently, but the protocol needs to address how the incoming data will be managed…

References

Suggest reference list needs to be reviewed for consistency of style of capitalization of article titles.

#18 – needs to be completed with correct full citation details: Menzes KKP, Nascimento LR, Avelino PR, Polese JC, Salmela LFT (2018) A review on respiratory muscle training devices . J Pulm Respir Med 8:451. doi: 10.4172/2161-105X.1000451

In a submission on this topic, other potentially relevant articles such as those listed below (non-exhaustive and non-prioritized listing) may have been pertinent and valuable inclusions within the Introduction and/or Discussion??(accepting they are not necessarily IMT focused, but more related to this study cohort and current practice)

Turquetto, A. L. R., Dos Santos, M. R., Agostinho, D. R., Sayegh, A. L. C., de Souza, F. R., Amato, L. P., Barnabe, M. S. R., de Oliveira, P. A., Liberato, G., Binotto, M. A., Negrão, C. E., Canêo, L. F., Trindade, E., Jatene, F. B., & Jatene, M. B. (2021). Aerobic exercise and inspiratory muscle training increase functional capacity in patients with univentricular physiology after Fontan operation: A randomized controlled trial. International journal of cardiology, 330, 50–58. https://doi.org/10.1016/j.ijcard.2021.01.058
Wu, F. M., Opotowsky, A. R., Denhoff, E. R., Gongwer, R., Gurvitz, M. Z., Landzberg, M. J., Shafer, K. M., Valente, A. M., Uluer, A. Z., & Rhodes, J. (2018). A pilot study of inspiratory muscle training to improve exercise capacity in patients with fontan physiology. Seminars in thoracic and cardiovascular surgery, 30(4), 462–469. https://doi.org/10.1053/j.semtcvs.2018.07.014
Abdulkarim, A., Shaji, S., Elfituri, M., Gunsaulus, M., Zafar, M. A., Zaidi, A. N., Pass, R. H., Feingold, B., Kurland, G., Kreutzer, J., Ghassemzadeh, R., Goldstein, B., West, S., & Alsaied, T. (2023). Pulmonary complications in patients with fontan circulation: JACC Review Topic of the Week. Journal of the American College of Cardiology, 81(25), 2434–2444. https://doi.org/10.1016/j.jacc.2023.04.036
Scheffers, L. E., Berg, L. E. M. V., Ismailova, G., Dulfer, K., Takkenberg, J. J. M., & Helbing, W. A. (2021). Physical exercise training in patients with a Fontan circulation: A systematic review. European journal of preventive cardiology, 28(11), 1269–1278. https://doi.org/10.1177/2047487320942869
Ferrer-Sargues, F. J., Peiró-Molina, E., Salvador-Coloma, P., Carrasco Moreno, J. I., Cano-Sánchez, A., Vázquez-Arce, M. I., Insa Albert, B., Sepulveda Sanchis, P., & Cebrià i Iranzo, M. À. (2020). Cardiopulmonary rehabilitation improves respiratory muscle function and functional capacity in children with congenital heart disease. A prospective cohort study. International Journal of Environmental Research and Public Health, 17(12), 4328–. https://doi.org/10.3390/ijerph17124328
McBride MG, Burstein DS, Edelson JB, Paridon SM. Cardiopulmonary rehabilitation in pediatric patients with congenital and acquired heart disease. J Cardiopulm Rehabil Prev. 2020;40(6):370–377.
Gauthier N, Curran T, O’Neill JA, Alexander ME, Rhodes J. Establishing a comprehensive pediatric cardiac fitness and rehabilitation program for congenital heart disease. Pediatr Cardiol. 2020;41(8):1569–1579..
Akamagwuna U, Badaly D. Pediatric cardiac rehabilitation: a review. Curr Phys Med Rehabil Rep. 2019;7(2):67-80. doi:10.1007/s40141-019-00216-9.
Longmuir PE, Brothers JA, de Ferranti SD, et al. Promotion of physical activity for children and adults with congenital heart disease: a scientific statement from the American Heart Association. Circulation. 2013;127(21):2147–2159.
Tikkanen AU, Oyaga AR, Riaño OA, Álvaro EM, Rhodes J. Paediatric cardiac rehabilitation in congenital heart disease: a systematic review. Cardiol Young. 2012;22(3):241–250
Duppen, N., Etnel, J. R., Spaans, L., Takken, T., van den Berg-Emons, R. J., Boersma, E., Schokking, M., Dulfer, K., Utens, E. M., Helbing, W., & Hopman, M. T. (2015). Does exercise training improve cardiopulmonary fitness and daily physical activity in children and young adults with corrected tetralogy of Fallot or Fontan circulation? A randomized controlled trial. The American Heart Journal, 170(3), 606–614. https://doi.org/10.1016/j.ahj.2015.06.018
Clarke, S. L., Milburn, N. C., Menzies, J. C., & Drury, N. E. (2023). The provision and impact of rehabilitation provided by Physiotherapists in children and young people with congenital heart disease following cardiac surgery: A scoping review. Physiotherapy. https://doi.org/10.1016/j.physio.2023.09.001
Beningfield, A., & Jones, A. (2018). Peri-operative chest physiotherapy for paediatric cardiac patients: a systematic review and meta-analysis. Physiotherapy, 104(3), 251–263. https://doi.org/10.1016/j.physio.2017.08.011
Gauthier, N., Curran, T., O’Neill, J. A., Alexander, M. E., & Rhodes, J. (2020). Establishing a comprehensive pediatric cardiac fitness and rehabilitation program for congenital heart disease. pediatric Cardiology, 41(8), 1569–1579. https://doi.org/10.1007/s00246-020-02413-z
Tran, D., Maiorana, A., Ayer, J., Lubans, D. R., Davis, G. M., Celermajer, D. S., d'Udekem, Y., & Cordina, R. (2020). Recommendations for exercise in adolescents and adults with congenital heart disease. Progress in cardiovascular diseases, 63(3), 350–366. https://doi.org/10.1016/j.pcad.2020.03.002

Finally this reviewer is reminded of the following publication and musing of its relevance and message when considering this protocol:

Illidi, C. R., Romer, L. M., Johnson, M. A., Williams, N. C., Rossiter, H. B., Casaburi, R., & Tiller, N. B. (2023). Distinguishing science from pseudoscience in commercial respiratory interventions: an evidence-based guide for health and exercise professionals. European journal of applied physiology, 123(8), 1599–1625. https://doi.org/10.1007/s00421-023-05166-8

The authors would do well to avoid such concerns potentially being within readers' perceptions by providing further details supporting their rationale and justification for their chosen study design and methodology protocol.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Yau DKW, Underwood MJ, Joynt GM, Lee A: Effect of preparative rehabilitation on recovery after cardiac surgery: A systematic review.Ann Phys Rehabil Med. 2021; 64 (2): 101391 PubMed Abstract | Publisher Full Text
2. Steinmetz C, Bjarnason-Wehrens B, Walther T, Schaffland TF, et al.: Efficacy of Prehabilitation Before Cardiac Surgery: A Systematic Review and Meta-analysis.Am J Phys Med Rehabil. 2023; 102 (4): 323-330 PubMed Abstract | Publisher Full Text
3. Olsen DB, Pedersen PU, Noergaard MW: Prehabilitation before elective coronary artery bypass grafting surgery: a scoping review.JBI Evid Synth. 2023; 21 (6): 1190-1242 PubMed Abstract | Publisher Full Text
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Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Critical care; acute care; rehabilitation; physical therapy; respiratory care

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Effect of Powerbreath Medic Plus versus Threshold IMT on maximal inspiratory pressure and functional capacity in post-operative ventricular septal defect closure: A protocol for a randomized controlled trial

Abstract

Keywords

Introduction

Aim and objectives

Protocol

Ethics and consent

Trial design

Participants and recruitment

Figure 1. Showing consort diagram of study protocol.

Inclusion criteria

Exclusion criteria

Experimental group intervention

Table 1. Conservative physiotherapy management.

Control group intervention

Outcomes

Sample size calculation

Analysis

Primary outcome

Primary end point (description)

Discussion

Dissemination

Study status

Data availability

Reporting guidelines

Acknowledgements

References

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