Efficacy of POWERbreathe Medic Plus device on maximal inspiratory pressure, functional capacity and quality of life in coronary artery bypass graft patients: A randomized controlled trial protocol

Vishnu Vardhan; Dhanashri N. Nikhade

doi:10.12688/f1000research.144783.1

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Efficacy of POWERbreathe Medic Plus device on maximal inspiratory pressure, functional capacity and quality of life in coronary artery bypass graft patients: A randomized controlled trial protocol

[version 1; peer review: awaiting peer review]

Vishnu Vardhan¹, Dhanashri N. Nikhade ¹

PUBLISHED 10 May 2024

Author details Author details

¹ Cardiorespiratory Physiotherapy Department,, Ravi nair physiotherapy college, datta meghe institute of higher education and research, Wardha, Maharashtra, 442001, India

Vishnu Vardhan
Roles: Conceptualization, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Dhanashri N. Nikhade
Roles: Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS AWAITING PEER REVIEW

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

Abstract

Coronary artery disease (CAD) is a prominent cause of illness and mortality worldwide, with a significant amount of coronary artery bypass graft (CABG) surgeries performed each year. It is a complicated technique that results in several clinical and functional issues. While CABG is an effective treatment, it comes with clinical and functional challenges, including reduced lung volume, maximal inspiratory and expiratory pressure, and thoracic mobility after surgery. Incisional pain has been associated with a decline in postoperative lung function; however, this resolves a month following surgery. There is no documented association between respiratory muscle strength and lung function after heart surgery. The POWERbreathe Medic Plus is intended for patients who have extremely weak breathing muscles as a result of illness, hospitalization, or existing respiratory health disorders such as Chronic Obstructive Pulmonary Disease (COPD) and asthma. To address these challenges, a study will investigate the efficacy of the POWERbreathe Medic Plus device in improving maximal inspiratory pressure, functional capacity, and quality of life in CABG patients.

CTRI no. – CTRI/2023/04/052116

Link-https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODMxNTA=&Enc=&userName=CTRI/2023/04/052116

CTRI registration date – 28/04/2023

Keywords

Powerbreathe medic plus Device, Coronary Artery Bypass Graft, quality of life, maximal inspiratory pressure, functional capacity.

Corresponding author: Dhanashri N. Nikhade

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2024 Vardhan V and Nikhade DN. 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: Vardhan V and Nikhade DN. Efficacy of POWERbreathe Medic Plus device on maximal inspiratory pressure, functional capacity and quality of life in coronary artery bypass graft patients: A randomized controlled trial protocol [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:472 (https://doi.org/10.12688/f1000research.144783.1) First published: 10 May 2024, 13:472 (https://doi.org/10.12688/f1000research.144783.1) Latest published: 10 May 2024, 13:472 (https://doi.org/10.12688/f1000research.144783.1)

Introduction

Coronary artery disease is a major reason for illness and fatality worldwide. In India, every year, around 1,40,000 CABG (Coronary Artery Bypass Graft) surgeries are carried out. It is a revascularization method that involves redirecting blood flow to other arteries to enhance blood supply to the heart muscles.¹ Despite significant breakthroughs in clinical care and interventional treatments, CABG is the most widely utilized type of cardiac surgery performed globally, and an excellent therapy for reducing symptoms and mortality in individuals with coronary artery disease (CAD).²^,³ CABG, on the other hand, is a challenging procedure that causes a host of clinical and functional issues.⁴ Some degree of pulmonary impairment is unavoidable in the immediate postoperative period following CABG.⁵ These effects may persist, resulting in 25-30% reductions in lung volume,⁶ maximal inspiratory and expiratory pressure (MIP and MEP) relative to expected values),⁷ and thoracic mobility.⁸

The patient has a sternotomy and is then connected to a cardiorespiratory bypass machine during coronary artery bypass grafting (CABG), the usual treatment for CAD.⁹ However, this form of surgery has a variety of postoperative complications. Two of the most prevalent symptoms are inactivity and pulmonary impairment.¹⁰ These concerns may be connected with socioeconomic costs such as prolonged hospital stays, substantial treatment expenditures, ICU care for the majority of patients, or even fatality if the patient is not effectively managed.¹¹ General anesthesia, mechanical ventilation duration, cardiopulmonary bypass, and the sternotomy incision can all have an impact on postoperative pulmonary function following heart surgery.¹² The use of cardiopulmonary bypass and general anesthesia in cardiac surgery is a crucial factor in patient outcomes.¹³ PPCs have been connected to various cardiopulmonary bypass-related events, including blood exposure to artificial materials, body temperature fluctuation, organ ischemia-reperfusion, surgical trauma, and endotoxin release; all of these generate an immediate inflammatory response.¹⁴^–¹⁶

Anesthesia may increase the alveolar-arterial oxygen gradient and decrease functional residual capacity and vital capacity, leading to hypoxemia and atelectasis. Anesthetic medications predispose to PPCs by producing immunological dysfunction, which leads to lung damage. Incisional discomfort has been linked to a decrease in postoperative lung function; however, this resolves within a month of surgery.¹⁷

The POWERbreathe Medic Plus has the lowest initial load of any Plus device, 9 cm H₂O. This gadget is used for low-load respiratory muscle training. The Powerbreathe Medic Plus is intended for those who have very weak breathing muscles as a result of, for example, illness, hospitalization, or existing respiratory health disorders such as COPD and asthma.

Aim: To study the efficacy of POWERbreathe Medic Plus device on maximal inspiratory pressure, functional capacity, and quality of life in Coronary Artery Bypass Graft Patients.

Objectives

Primary objectives

1) To assess the strength of diaphragm by measuring maximum inspiratory pressure (PImax) in Coronary Artery Bypass Graft Patients by a Power Breathe Medic Plus Device.

Secondary objectives

1) To assess functional capacity by measuring the Six-minute walk distance.
2) To assess quality of life using SF-36 questionnaire.
3) Duration of hospital stay.

Trial design

The study will be a single-center, parallel-group, open-label, randomized controlled trial.

Protocol

Study approval from the Ethics Committee of the Datta Meghe Institute of Higher Education and Research, study participants will be selected from the Cardiovascular and Thoracic Surgery Unit of Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha, Maharashtra, based on inclusion and exclusion criteria. Subjects will be contacted and chosen according to the study’s criteria. The sequentially numbered opaque sealed envelope (SNOSE) technique will be employed in a randomised strategy to assign members. This research protocol will examine the impact of the POWERbreathe Medic Plus device on peak inspiratory pressure, functional capacity, and quality of life in transplant patients through an independent two-group study. coronary bypass surgery. There will be 72 individuals in the trial (36 in each traditional group).

Eligibility criteria

Inclusion criteria

1. Patients who will sign the written informed consent form.
2. Both male and female patients.
3. Patients who have undergone a coronary artery bypass graft with an age range of 40-70 years.

Exclusion criteria

1. Patients who had developed hemodynamic complications (e.g., preoperative Myocardial Infarction, Lung Congestion, Post-operative renal failure, patients on Intra-aortic balloon pump or arrhythmia needed for a pacemaker).
2. CABG patient on postoperative mechanical ventilation (more than 24 hours).
3. No previous neurological complications in the last 6 months.
4. Unstable angina.

Interventions

Experimental group

The strength of inspiratory muscles will be assessed by a maximal inspiratory pressure device (PImax) device. POWERbreathe Medic plus the device will be given. The patient will be made to sit in a comfortable position with back supported, shoulders relaxed and handle grip of the device in the hand. The mouthpiece will be placed fully into the mouth so that the outer shield will be between lips and gums and a nose clip will be placed on the nose to close both nostrils. Once comfortable, the patient will be asked to take normal-sized, relaxed breaths in and out through the device and will start with the lowest resistance setting and gradually progress to a high 30% of the current PImax. After POWERbreathe Medic Plus device, conventional chest physiotherapy exercises are provided twice a day for two weeks. Two weeks later, participants will be reassessed using the same outcome measures of conditioning effects of the intervention.

Control group

Conventional Chest Physiotherapy exercises will be given in the form of Diaphragmatic breathing exercises, Thoracic expansion exercises, and Incentive spirometry. Exercises are provided twice a day for two weeks. Two weeks later, participants will be reassessed using the same outcome measures of conditioning effects of the intervention.

Outcomes

Primary outcome

Change in Maximal Inspiratory Pressure (PImax)

Micro-RPM calculates the strength of respiratory muscle by calculating the respiratory pressure exerted by patients. To force all breathing to occur through the mouth, the patient must sit in a comfortable position and fasten the nose clip to the nose. The patient must make a tight seal with their lips around the mouthpiece. They must breathe in more deeply than usual, but not all the way, and exhale gently while maintaining an inhalation-to-exhalation ratio of 1:1 or 1:2 (exhale for a lengthier period than they inhale).

Secondary outcome

To change the six-minute walk distance

Functional capacity is determined by a six-minute walk distance. The 6MWD is a simple and inexpensive submaximal exercise test that the patient tolerates well. It is a field test that is used to measure functional capacity after exercise in persons who have a range of cardiac and pulmonary issues.¹⁸

Change in quality of life

The SF-36 surveys,¹⁹ which assess quality of life, has 36 sections (questions) that examine physical, psychological, and social functioning. In health research, the SF-36 is the most used quality of life questionnaire. With 36 items encompassing eight areas (social functioning (SF), general health (GH), vitality (VT), physical functioning (PF), physical role functioning (RP), physical pain (BP), and physical functioning (PF), it is a multidimensional questionnaire including both emotional role functioning and mental wellness. The combined findings of the first four areas and the last four areas are a physical health assessment (PCS) and a mental health assessment (MCS), respectively.¹⁹

Changes in duration of hospital stay

The length of stay is calculated from the date of admission and date of discharge.

Method

Study Design: Randomised control trial.

Study Setting: This study will be carried out in Cardiovascular and Thoracic Surgery Unit, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha, Maharashtra.

Targeted population: CABG patients from age group of 30-60 years.

Sampling technique: Simple Random Sampling Technique.

Allocation: Sequentially numbered opaque sealed envelope (SNOSE) technique

Sample size calculation.

Formula Using Mean difference

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

Z_α = 1.96

α = Type l error at 5% at both sides two tailed

Z_β = 1.645 Power at 95%.

Difference (Mean) result in 6MWT for conventional chest therapy = 125 (As per ref. article).

Considering Std. Dev = 145.8

According to reference articles.

N1 = 2 * [{(1.96 + 1.645)}^{2} {(1.96)}^{2}] / {(1.65)}^{2} = 32

Total samples required = 36 per Group.

Considering 10% drop out = 4

The total sample size = 72

Ref Article: - Moderate-to-high intensity inspiratory muscle training improves the effects of combined training on exercise capacity in patients after coronary artery bypass graft surgery: A randomized clinical trial.²⁰

Study duration: The study duration will be one year. The flowchart of consort diagram is shown in Figure 1.

Figure 1. Flowchart of consort diagram.

Statistical analysis

RStudio software version 4.3 will be used to determine the final result. Descriptive statistics (age, BMI) will be produced based on a quantitative examination of the variables` mean, standard deviation, maximum, minimum, and median. For the qualitative assessment, frequency and percentage will be calculated across the variables (lifestyle, gender, and comorbidities). Every inferential statistical result will be generated and analyzed for significance at the 5% level, represented by P = less than 0.05. The outcome variable (MicroRPM for PImax measurement) will be the primary variable, and the supplementary variables (6MWT, SF-36, and length of hospital stay) will be compared between pre- and post-results using paired-t tests. The Kolmogorov-Smirnov test is first performed to determine the normality of the outcome variable data. Information that deviates from common sense.

Dissemination

The authors are planning to present the research article at a conference.

Study status

The study is yet to be started.

Ethical considerations

This study was approved by Datta Meghe Institute of Higher Education on 21 March 2023 (DMIHER (DU)/IEC/2023/545).

Written informed consent will be obtained from the participants.

Discussion

Reduced respiratory muscle tone has been linked with decreased functional capacity in cardiac operations patients, which leads to a protracted period of lung function recovery as well as the commencement of physical deconditioning that can last several weeks.²¹ Changes in lung sizes and capabilities, alveolar dysfunction, depression of central respiratory stimulation, and mechanical disorders of thoracic function all contribute to RMS changes.²²^,²³

Furthermore, it is well known that the majority of cardiac surgery patients have preoperative bouts of muscular weakness, which is increased after the surgery.²⁴ However, although the respiratory muscles are similarly passive, they are weaker than the peripheral muscles.²⁴^,²⁵ Following coronary artery bypass graft (CABG) surgery, patients may experience postoperative pulmonary complications (PPCs) are a significant cause of morbidity and death, as well as an increase in hospital stay and resource utilization.²⁶^,²⁷

Adele Cook et al. (2023) studied the effect of Preoperative threshold inspiratory muscle training in adults undergoing cardiac surgery. According to the study, preoperative threshold inspiratory muscle training has the potential to minimize the postoperative duration of hospital stay and pulmonary complications following heart surgery.²⁸

Xiaoyu Chen et al. (2019) undertook a study to see if short-term rigorous preoperative inspiratory muscle training could reduce the occurrence of postoperative pulmonary problems in patients undergoing heart surgery. The study concluded that a 5-day intense schedule of preoperative inspiratory muscle training reduced the frequency and duration of postoperative hospitalization in patients undergoing heart surgery.²⁹

Thayse Campos de Menezes et al. (2018) conducted a study to evaluate the effect of respiratory and peripheral muscle strength after cardiac surgery. According to study findings after cardiac surgery, there is a decline in respiratory and peripheral muscle strength.³⁰

Alquaimi M et al. (2017) conducted a study on pulmonary rehabilitation program (PRP) in ILD patients. This study revealed that IMT in ILD patients improved 6MWD, Fatigue severity scale (FSS) and MIP.³¹

Kazuki Okura et al. (2016) conducted a study on the efficacy of moderate-intensity, short-duration inspiratory muscle training in COPD patients. According to the study finding it enhances PImax and exercise capacity in older COPD patients.³²

Bárbara Maria Hermes et al. (2015) studied the effects of a short-term inspiratory muscle training program combined with aerobic and resistance exercise on respiratory muscle strength, functional capacity, and quality of life in patients who had coronary artery bypass surgery. This concludes that inspiratory muscle training used for shorter periods had the potential to improve respiratory muscle strength, and functional capacity in coronary artery bypass surgery.²¹

Ethical considerations

This study was approved by Datta Meghe Institute of Higher Education on 21 March 2023 (DMIHER (DU)/IEC/2023/545).

Written informed consent will be obtained from the participants.

Data availability

Underlying data

No data are associated with this article.

Reporting guidelines

Figshare: SPIRIT checklist for ‘Efficacy of POWERbreathe Medic Plus device on maximal inspiratory pressure, functional capacity and quality of life in coronary artery bypass graft patients: A randomized controlled trial protocol’, 10.6084/m9.figshare.24504175.v1.³³

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

References

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2. Gaudino M, Taggart D, Suma H, et al.: The choice of conduits in coronary artery bypass surgery. J. Am. Coll. Cardiol. 2015 Oct 13; 66(15): 1729–1737. Publisher Full Text
3. Hossen A, Jaju D, Al-Abri M, et al.: Investigation of heart rate variability of patients undergoing coronary artery bypass grafting (CABG). Technol. Health Care. 2017 Jan 1; 25(2): 197–210. PubMed Abstract | Publisher Full Text
4. Laizo A, Delgado GMFE, Rocha GM: Complications that increase the time of hospitalization at ICU of patients submitted to cardiac surgery. Braz. J. Cardiovasc. Surg. 2010; 25: 166–171. PubMed Abstract | Publisher Full Text
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6. Westerdahl E, Lindmark B, Eriksson T, et al.: Deep-breathing exercises reduce atelectasis and improve pulmonary function after coronary artery bypass surgery. Chest. 2005 Nov 1; 128(5): 3482–3488. PubMed Abstract | Publisher Full Text
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12. Cavenaghi S, Ferreira LL, Marino LH, et al.: Respiratory physiotherapy in the pre and postoperative myocardial revascularization surgery. Braz. J. Cardiovasc. Surg. 2011; 26: 455–461. PubMed Abstract | Publisher Full Text
13. De Backer D, Dubois MJ, Schmartz D, et al.: Microcirculatory alterations in cardiac surgery: effects of cardiopulmonary bypass and anesthesia. Ann. Thorac. Surg. 2009 Nov 1; 88(5): 1396–1403. PubMed Abstract | Publisher Full Text
14. Evora PR, Bottura C, Arcêncio L, et al.: Key points for curbing cardiopulmonary bypass inflammation. Acta Cir. Bras. 2016; 31: 45–52. PubMed Abstract | Publisher Full Text
15. Levy JH, Tanaka KA: Inflammatory response to cardiopulmonary bypass. Ann. Thorac. Surg. 2003 Feb 1; 75(2): S715–S720. Publisher Full Text
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Author details Author details

¹ Cardiorespiratory Physiotherapy Department,, Ravi nair physiotherapy college, datta meghe institute of higher education and research, Wardha, Maharashtra, 442001, India

Vishnu Vardhan
Roles: Conceptualization, Investigation, Methodology, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Dhanashri N. Nikhade
Roles: Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

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Published: 10 May 2024, 13:472

https://doi.org/10.12688/f1000research.144783.1

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© 2024 Vardhan V and Nikhade DN. 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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Vardhan V and Nikhade DN. Efficacy of POWERbreathe Medic Plus device on maximal inspiratory pressure, functional capacity and quality of life in coronary artery bypass graft patients: A randomized controlled trial protocol [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:472 (https://doi.org/10.12688/f1000research.144783.1)

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[1] 1. Kaul U, Bhatia V: Perspective on coronary interventions & cardiac surgeries in India. Indian J. Med. Res. 2010 Nov 1; 132(5): 543–548. PubMed Abstract

[2] 2. Gaudino M, Taggart D, Suma H, et al.: The choice of conduits in coronary artery bypass surgery. J. Am. Coll. Cardiol. 2015 Oct 13; 66(15): 1729–1737. Publisher Full Text

[3] 3. Hossen A, Jaju D, Al-Abri M, et al.: Investigation of heart rate variability of patients undergoing coronary artery bypass grafting (CABG). Technol. Health Care. 2017 Jan 1; 25(2): 197–210. PubMed Abstract | Publisher Full Text

[4] 4. Laizo A, Delgado GMFE, Rocha GM: Complications that increase the time of hospitalization at ICU of patients submitted to cardiac surgery. Braz. J. Cardiovasc. Surg. 2010; 25: 166–171. PubMed Abstract | Publisher Full Text

[5] 5. Calles AC, Lira JL, Granja KS, et al.: Pulmonary complications in patients undergoing coronary artery bypass grafting at a hospital in Maceio, Brazil. Fisioterapia em Movimento. 2016 Oct; 29: 661–667. Publisher Full Text

[6] 6. Westerdahl E, Lindmark B, Eriksson T, et al.: Deep-breathing exercises reduce atelectasis and improve pulmonary function after coronary artery bypass surgery. Chest. 2005 Nov 1; 128(5): 3482–3488. PubMed Abstract | Publisher Full Text

[7] 7. Caruso FC, Simões RP, Reis MS, et al.: High-intensity inspiratory protocol increases heart rate variability in myocardial revascularization patients. Braz. J. Cardiovasc. Surg. 2016 Jan; 31: 38–44. PubMed Abstract | Publisher Full Text

[8] 8. Kristjánsdóttir Á, Ragnarsdóttir M, Hannesson P, et al.: Respiratory movements are altered three months and one year following cardiac surgery. Scand. Cardiovasc. J. 2004 Jan 1; 38(2): 98–103. PubMed Abstract | Publisher Full Text

[9] 9. Bottio T, Rizzoli G, Caprili L, et al.: Full-sternotomy off-pump versus on-pump coronary artery bypass procedures: in-hospital outcomes and complications during one year in a single center. Tex. Heart Inst. J. 2003; 30(4): 261–267. PubMed Abstract

[10] 10. Montrief T, Koyfman A, Long B: Coronary artery bypass graft surgery complications: A review for emergency clinicians. Am. J. Emerg. Med. 2018 Dec 1; 36(12): 2289–2297. PubMed Abstract | Publisher Full Text

[11] 11. Rajaei S, Dabbagh A: Risk factors for postoperative respiratory mortality and morbidity in patients undergoing coronary artery bypass grafting. Anesth. Pain Med. 2012; 2(2): 60–65. PubMed Abstract | Publisher Full Text | Free Full Text

[12] 12. Cavenaghi S, Ferreira LL, Marino LH, et al.: Respiratory physiotherapy in the pre and postoperative myocardial revascularization surgery. Braz. J. Cardiovasc. Surg. 2011; 26: 455–461. PubMed Abstract | Publisher Full Text

[13] 13. De Backer D, Dubois MJ, Schmartz D, et al.: Microcirculatory alterations in cardiac surgery: effects of cardiopulmonary bypass and anesthesia. Ann. Thorac. Surg. 2009 Nov 1; 88(5): 1396–1403. PubMed Abstract | Publisher Full Text

[14] 14. Evora PR, Bottura C, Arcêncio L, et al.: Key points for curbing cardiopulmonary bypass inflammation. Acta Cir. Bras. 2016; 31: 45–52. PubMed Abstract | Publisher Full Text

[15] 15. Levy JH, Tanaka KA: Inflammatory response to cardiopulmonary bypass. Ann. Thorac. Surg. 2003 Feb 1; 75(2): S715–S720. Publisher Full Text

[16] 16. Justus G, Walker C, Rosenthal LM, et al.: Immunodepression after CPB: Cytokine dynamics and clinics after pediatric cardiac surgery–A prospective trial. Cytokine. 2019 Oct 1; 122: 154018. PubMed Abstract | Publisher Full Text

[17] 17. Rouhi-Boroujeni H, Rouhi-Boroujeni H, Rouhi-Boroujeni P, et al.: Long-term pulmonary functional status following coronary artery bypass grafting surgery. ARYA Atheroscler. 2015 Mar; 11(2): 163–166. PubMed Abstract

[18] 18. Giannitsi S, Bougiakli M, Bechlioulis A, et al.: 6-minute walking test: a useful tool in the management of heart failure patients. Ther. Adv. Cardiovasc. Dis. 2019 Aug; 13: 175394471987008. Publisher Full Text

[19] 19. Brazier JE, Harper R, Jones NM, et al.: Validating the SF-36 health survey questionnaire: new outcome measure for primary care. Br. Med. J. 1992 Jul 18; 305(6846): 160–164. PubMed Abstract | Publisher Full Text | Free Full Text

[20] 20. Dos Santos TD, Pereira SN, Portela LO, et al.: Moderate-to-high intensity inspiratory muscle training improves the effects of combined training on exercise capacity in patients after coronary artery bypass graft surgery: A randomized clinical trial. Int. J. Cardiol. 2019 Mar 15; 279: 40–46. PubMed Abstract | Publisher Full Text

[21] 21. Hermes BM, Cardoso DM, Gomes TJ, et al.: Short-term inspiratory muscle training potentiates the benefits of aerobic and resistance training in patients undergoing CABG in phase II cardiac rehabilitation program. Braz. J. Cardiovasc. Surg. 2015 Jul; 30: 474–481. PubMed Abstract | Publisher Full Text

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Efficacy of POWERbreathe Medic Plus device on maximal inspiratory pressure, functional capacity and quality of life in coronary artery bypass graft patients: A randomized controlled trial protocol

Abstract

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Introduction

Objectives

Primary objectives

Secondary objectives

Protocol

Eligibility criteria

Interventions

Outcomes

Method

Figure 1. Flowchart of consort diagram.

Statistical analysis

Dissemination

Study status

Ethical considerations

Discussion

Ethical considerations

Data availability

Underlying data

Reporting guidelines

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