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Study Protocol

Effect of diaphragmatic stretch technique on thoracic excursion and pulmonary function in COPD patients: Study protocol for randomized controlled trial.

[version 1; peer review: 1 approved, 1 approved with reservations]
PUBLISHED 04 Apr 2024
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Limited airflow is a defining feature of COPD, a respiratory disease that frequently results in reduced thoracic movement and compromised lung function. The diaphragm, which is the main breathing muscle, is essential for healthy lung expansion and ventilation. The diaphragm muscle’s flexibility and mobility are intended to be enhanced via diaphragmatic stretching. This method can enhance respiratory health and assist in returning the diaphragm to its original state. Patients with COPD may benefit from improved lung expansion and ventilation because of this. The usefulness of integrating the diaphragmatic stretch approach with traditional chest physical therapy is not well-established. Thus, research is needed to ascertain how the diaphragmatic stretch technique affects lung function and thoracic excursion in COPD patients. This study aims to ascertain how the diaphragmatic stretch technique affects thoracic excursion and pulmonary function (FEV1, FVC, FEV1/FVC, FEF25%-75%, PEFR) in individuals with COPD. There will be 58 COPD patients enrolled in total for this trial; 29 will receive traditional chest physiotherapy along with the diaphragmatic stretch technique, and 29 will receive traditional chest physiotherapy exclusively. Two weeks will pass throughout the intervention. Prior to the intervention, pre-outcome measures will be evaluated, and two weeks later, post-outcome measures will be evaluated once more. The anticipated outcome of this study is that the diaphragmatic stretch technique can enhance thoracic excursion and improve pulmonary function just as well as traditional chest physiotherapy when used in conjunction with it.

Keywords

COPD, diaphragmatic stretch, conventional chest physiotherapy, thoracic excursion, pulmonary function

Introduction

Chronic Obstructive Pulmonary Disease (COPD) is a diverse lung illness that is typified by persistent respiratory symptoms (such as coughing, sputum production, dyspnoea, and/or exacerbations) brought on by abnormalities of the alveoli (emphysema) and/or airways (bronchitis, bronchiolitis) that result in persistent, frequently progressive airflow obstruction.1 Air entrapment and lung hyperinflation are two prominent indicators of COPD.1

As the lung volume can be considered the respiratory muscle’s length index, the diaphragm’s contraction force, lung volumes, and lung capacities can all be impacted by shortening it.2 The diaphragm’s ability to function is compromised by these two prominent COPD features. They result in a mechanical disadvantage because they shorten its operational length and alter the mechanical interaction between its numerous elements. These pathological alterations result in the diaphragm’s inability to expand and elevate the lower rib cage, which causes the lower ribs’ transverse diameter to contract during inspiration. While functional capability decreases, these changes result in an increase in breathing effort.3,4

Diaphragm and rib cage movements gradually become lessened in patients with respiratory disorders due to alternate cyclical usage of the chest wall or diaphragm, which creates resistance to the chest wall and increases effort of breathing since it puts more strain on the respiratory muscles. Stretching muscle fibres encourages the growth of sarcomeres, which in turn lengthens shortened muscles. The ability of the respiratory muscles to contract would generally improve with appropriate length, leading to an increase in thoracic expansion and improved respiratory mechanics performance.2,3

Numerous manual therapies have been suggested for the treatment of COPD symptoms because of the relationship between the musculoskeletal and respiratory systems. Increasing the thoracic structures’ range of motion is a common goal in respiratory mechanics. A respiratory muscle stretch aims to extend both the muscles that contract during inspiration and expiration, which are found in the chest wall. By relaxing and strengthening diaphragmatic contraction, the diaphragmatic stretch technique seeks to increase the pressure gradient between the thorax and abdomen.7

The healing process in manual therapy involves manipulating the hands for therapeutic purposes, which eventually impacts the body’s ability to heal itself. Both the individual’s general behaviour and the level of local repairs may change. Despite the benefits of manual treatment for the respiratory system, studies utilizing this approach are uncommon.4 The immediate effects of diaphragmatic stretch technique on improving thoracic excursion have been seen in a cross-over trial with washout period of three hours and can be safely recommended in clinically stable COPD patients.4 It is also discovered that diaphragmatic stretching along with conventional chest physiotherapy significantly improves pulmonary function (FEV1/FVC) and thoracic excursion in COPD patients.2 Other parameters of pulmonary function (FEF25%-75%, PEFR) are also important as they are sensitive measure of small airway obstruction and to know about the complications related to COPD.5,6 The effect of diaphragmatic stretch in addition to conventional chest physiotherapy on these parameters of pulmonary function are not known. Therefore, the goal of the current study is to determine how the diaphragmatic stretch technique along with conventional chest physiotherapy helps in improving thoracic excursion and pulmonary function in COPD patients.

Protocol

Trail design: A single centre, parallel-group, active controlled group, randomized control trial.

Methods: Study volunteers will only be accepted by the Acharya Vinoba Bhave Rural Hospital’s Respiratory Medicine OPD in Sawangi (Meghe), Wardha, Maharashtra, with permission from the Datta Meghe Institute of Higher Education and Research’s (DMIHER) institutional ethics committee. To screen the local population, strict adherence to the study’s inclusion and exclusion criteria will be upheld.

Aim

To study the effect of diaphragmatic stretch technique on thoracic excursion and pulmonary function in COPD patients.

Objectives

  • 1. To determine the effect of diaphragmatic stretch technique adjunct to conventional chest physiotherapy on thoracic excursion and pulmonary function in COPD patients.

  • 2. To determine the effect of conventional chest physiotherapy on thoracic excursion and pulmonary function in COPD patients.

  • 3. To compare the diaphragmatic stretch technique along with conventional chest physiotherapy as compared to conventional chest physiotherapy on thoracic excursion, and pulmonary function in COPD patients.

Inclusion criteria

  • 1. Both men and women between 35-65 years who are diagnosed with COPD by physician.

  • 2. Patients in 2023 who meet the GOLD criteria for mild to moderate COPD. The study will include two categories: moderate 50% FEV1 80% and mild FEV1 80% expected.

Exclusion criteria

  • 1. Unstable vital signs (arterial pressure < 100/60 mmHg, MAP < 80 mmHg).

  • 2. Dyspnoea score – 4-5.

  • 3. who have had abdominal or cardiothoracic surgery recently.

  • 4. A recent track record of injuries to the abdomen or chest wall.

  • 5. Any musculoskeletal disorder (scoliosis, kyphosis, severe osteoporosis).

  • 6. Any cardiovascular problems.

  • 7. History of psychiatric illness.

  • 8. Individuals who meet the GOLD criteria for COPD in 2023 and have severe to very severe disease. GOLD 4: extremely severe (FEV1 <30% expected) and severe (30% ≤ FEV1<50% projected) will not be included in the trial.

Outcomes

  • 1. Primary outcomes

    Thoracic excursion: “Thoracic excursion is the difference in thoracic circumference between peak inspiration and expiration recorded while standing with arms at the sides of the trunk.” To test upper thoracic excursion, an inch of tape wrapped around the chest on both the upper and lower thoracic levels will be utilized. For upper thoracic excursion the tape will be positioned on the third intercostal gap at the midclavicular line and the fifth thoracic spinous process. The tip of the xiphoid process and the 10th thoracic spinous process will be used to quantify lower thoracic excursion. To obtain data, participants will be instructed to hold their breath during peak expiration and inspiration.2,7

  • 2. Secondary outcomes

    Pulmonary function test: Spirometry (RMS HELIOS401) is the instrument that will be used to compute this particular measurement. Listed below are the components:

      FVC (Forced Vital Capacity) – “The FVC is the maximum gas volume that the patient may exhale fast and forcefully after a maximal inhale. The FVC maneuver is the name given to this procedure.”

      The vital capacity (VC) and FVC should not be separated by more than 200 milliliters.

      FEV1 (Forced Expiratory Volume in One Second) – “The volume expired during the first second of an FVC maneuver is measured as FEV1.”

      Values that are typical: In people with typical respiratory function, the forced expiratory volume is as follows:

      FEV1 is equivalent to 75%-85% of TVC.

      Ratio of FVC/FEV1: The ratios are calculated by dividing the predicted FVC by the predicted FEV1.2,8

    FEF25%-75%: “The percentage of the predicted value (%pred FEF25%-75%) is used to represent forced expiratory flow in this case. A forced expiratory flow is one that occurs on average between 25% and 75% of the required capacity.”5,9

    Peak expiratory flow rate – “The greatest flow that can be achieved during a forced vertical breathing exercise is known as the PEFR. Litres per second are the unit of measurement.”

    The typical range for adults is 100–850 L/min.6

Experimental group

Once diaphragmatic stretches are administered to this group, the strain is held for 15–30 seconds. Participants will be forced to sit upright. The therapist will come up behind the patient, his hands wrapped around the thoracic cage and curled fingers pushed into the subcostal borders. The rectus abdominis muscle will be relaxed by slightly rounding the subject’s trunk. With his hands at the subcostal edge, the therapist of the individual’s lower ribs and eased them caudally when the subject exhaled. As the patient inhales, firm but gentle traction will be maintained. Two sets of ten deep breaths each will be performed for this exercise, with a one-minute break in between. In addition to diaphragmatic stretch, traditional physiotherapy will include thoracic mobility exercises (thoracic flexion on both sides, trunk rotation), purse lip breathing, diaphragmatic breathing, shoulder mobility exercises (scapular protraction–retraction, elevation–depression, flexion–extension, abduction–adduction, medial–lateral rotation, horizontal abduction–adduction, and upward–downward rotation). Once a day for two weeks, perform ten repetitions of each exercise.2,510

Control group: All exercises related to shoulder mobility (flexion–extension, abduction–adduction, medial–lateral rotation, horizontal abduction–adduction, scapular protraction–retraction, elevation–depression, and upward–downward rotation) and thoracic mobility (lateral flexion on both sides, trunk rotation) will be provided exclusively to this group during their conventional physical therapy sessions. Once a day for two weeks, perform ten repetitions of each exercise.2,510

Safety outcomes: Unfavorable situations are always documented.

Research methods

Each research subject will provide written, informed consent. The institutional ethical committee of the DMIHER will authorize the study before choosing study individuals. Participants will be selected from Acharya Vinoba Bhave Rural Hospital’s respiratory medicine outpatient department in Sawangi (Meghe), Wardha, Maharashtra. The participant will first undergo a comprehensive evaluation. The participant will be selected as per inclusion and exclusion criteria. The participant will receive comprehensive information regarding the study and intervention. Prior to the process of randomization, the demographic information of the participants will be collected in order to allocate them 1:1 Group A and Group B into two groups. The therapist will be allocating and enrolling the patients and the same therapist will be assigning the participants in both the groups. Group A will receive diaphragmatic stretching in addition to conventional chest physiotherapy exercises, while Group B will receive conventional chest physiotherapy exercises alone. Both groups will contain patients. The intervention will take place over the course of two weeks, once a day for six days a week, or six sessions a week.8 The before and after intervention measures will be examined both before and after the intervention begins.

Sample size calculation

Study design: Randomized controlled trial.

Study setting: Acharya Vinoba Bhave Rural Hospital’s OPD for respiratory medicine in Sawangi, Wardha, will be the study’s site.

Targeted population: COPD patients in the age group of 35-65 years.

Sampling technique: Simple Random Sampling Technique

Allocation: Sequentially numbered opaque sealed envelope (SNOSE) technique

Sample size:

Formula for calculating sample size based on mean difference

n1=n2=2(Zα+Zβ)2σ2(δ)2

Primary Variable (thoracic excursion)

Mean ± SD (Before) result on thoracic excursion for conventional chest therapy (Control group) = 0.9111 ± 0.1833

Mean ± SD (After) result on thoracic excursion for conventional chest therapy (Control group) = 1.0444 ± 0.1667

Difference = 0.1333± 0.175 (As per ref. article)

According to the reference articles.

N1=2[(1.64+0.84)2(0.175)2]/(0.1333)2=22

Total number of samples required per group = 22

Taking 30% dropout into account = 7

The total sample size required per group is 29.

Notations:

Zα=1.64
α=Type I error at 5%
Zβ=0.84(1β)=Power at 80%
σ=std. dev

Ref Article: Comparison of Intercostal Stretch Technique Versus Diaphragmatic Breathing on Dyspnea, Chest Expansion And Functional Capacity in Stable COPD.10

Duration: 1 year

Analysis

Every outcome variable result will be shown in tables and explained using descriptive statistics. Thoracic excursion and pulmonary function test mean and standard deviation (SD) will be quantitatively assessed as the first test’s outcome variables. The interquartile range (IQR) and skewed distributions will be calculated using positional average (Median) statistics. Every binary and categorical variable must be stated in terms of frequency and percentages for the purpose of the qualitative evaluation. The entire statistical evaluation of findings will be computed using the free R software version 4.3.2. At the 5% level of significance (p 0.05), the inferential statistics used for evaluating the significant difference over the outcome variables will be examined.

Primary Variable: In order to compare two groups receiving intervention at the 5% level of significance (P ≤ 0.05), we will do a baseline to endline assessment.

To ascertain the significance of the mean, the intra-difference in measurement between the before and after analysis outcome variables will be evaluated using the paired t-test. Conversely, when comparing two groups, unpaired t-tests are employed to assess intergroup differences.

We will recruit a different non-parametric test (the Chi-square, Mann Whitney, or Wilcoxon test) if the data shows signs of remaining non-normally distributed. If the quantitative evaluation findings show a non-normal distribution across the sample, the mathematical technique will be used to convert the data for the outcome variables for testing normalcy into a normal distribution.

Discussion

Chronic obstructive pulmonary disease (COPD) is defined by an abnormality of the alveoli (emphysema) and/or airways (bronchitis, bronchiolitis) that produces a continuous restriction of airflow that regularly worsens. COPD is characterized by chronic respiratory symptoms such as dyspnoea, coughing up mucus, and/or exacerbations. One of the main characteristics of COPD is restricted airflow, which frequently results in changes in lung capacity and limited thoracic movement. For those with this illness, diaphragmatic stretching therapy has shown promising results in terms of thoracic excursion and lung function. The major objective of this study is to assess the impact of diaphragmatic stretching on individuals with COPD, specifically in relation to enhanced thoracic excursion and lung function.

Bonnie E. Ronish et al. in their research reported that beyond FEV1, %predFEF25%-75% offers further insights into the manifestation of a disease and helps to link the anatomic pathology and deranged physiology of COPD.9

Diaphragmatic stretching exercises can be incorporated into traditional physiotherapy to help patients with COPD improve their thoracic expansion and pulmonary function, as demonstrated by G. Swathi et al. (2021). The results of this study shed light on the most effective methods for managing COPD symptoms and, ultimately, improving patient outcomes.2

A team of researchers looked into how senior population chest expansion and pulmonary function were affected by chest mobility exercises and respiratory muscle stretching in 2020. Fascinatingly, respiratory muscle stretching was found to be significantly more helpful than chest mobility exercises, even though FVC, FEV1, and chest expansion improved with both exercises.11

In a recent study, Anusree Sreejith and her colleagues assessed the efficacy of respiratory muscle stretches and chest mobility exercises for older adults. Group A stretched their respiratory muscles while Group B concentrated on thoracic mobility exercises over a two-week period. Stretching the respiratory muscles was more advantageous than chest mobility exercises for increasing chest expansion, FVC, and FEV1. In the elderly population, both forms of physical activity enhanced chest expansion and lung function.12

A study by Do Sun Kwon et al concluded that careful monitoring should be done with COPD patients who present with low FEF25-75% values, even after having normal lung function.5

A 2019 study by Aishwarya Nair and colleagues found that diaphragmatic excursion and chest expansion can be improved in COPD patients by using manual diaphragm release techniques and diaphragmatic stretch. Twenty patients took part in the trial, and they were split into two groups at random. Both methods were successful.4

According to a study by Islam, Rofiqul et al. (2017), when combined with traditional physiotherapy, diaphragmatic and costal manipulations improve lung function, chest mobility, and total functional capacity in patients with chronic obstructive pulmonary disease (COPD).13

A 2017 study by Dangi Ashwini et al. found that in people with stable COPD, diaphragmatic breathing and the intercostal stretch technique both improve chest expansion and functional capacity while reducing dyspnoea. The study concluded that there was no appreciable difference in the effectiveness of the two strategies.10

Studies show that stretching the diaphragm, especially for people with COPD, can improve respiratory function. The act of ribcage extension and contraction improves thoracic excursion and mobility, enabling greater lung expansion and ventilation, and eventually improving respiratory function. Exercises that stretch the diaphragm can relieve tension, improve muscular coordination and strength, and improve breathing efficiency.

Dissemination: I’ve decided to present my study protocol at the last meeting.

Study status: Yet to be started.

Ethical considerations

The approval was obtained from the institutional ethics committee of Datta Meghe Institute of Higher Education and Research, Wardha with approval no. DMIHER (DU)/IEC/2023/1062, dated – 27/06/2023.

Also the trial was registered with Clinical Trial Registry of India with CTRI no – CTRI/2023/08/056408.

CTRI registration date – 11/08/2023.

Written informed consent will be obtained from all study participants for participation in the study and publication of their data.

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K. Chilhate P, Lalwani (Adwani) L and Vardhan V. Effect of diaphragmatic stretch technique on thoracic excursion and pulmonary function in COPD patients: Study protocol for randomized controlled trial. [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2024, 13:248 (https://doi.org/10.12688/f1000research.144784.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
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PUBLISHED 04 Apr 2024
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Reviewer Report 28 Aug 2024
Assem Khamis, University of Hull, Hull, England, UK 
Approved with Reservations
VIEWS 9
The study protocol investigates the potential impact of combining conventional physiotherapy with diaphragmatic stretching techniques versus using conventional chest physiotherapy alone on thoracic excursion and pulmonary function in COPD patients. The background section identified a gap in the existing literature ... Continue reading
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HOW TO CITE THIS REPORT
Khamis A. Reviewer Report For: Effect of diaphragmatic stretch technique on thoracic excursion and pulmonary function in COPD patients: Study protocol for randomized controlled trial. [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2024, 13:248 (https://doi.org/10.5256/f1000research.158629.r312213)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Reviewer Report 06 May 2024
Eirini Grammatopoulou, Department of Physiotherapy, University of West Attica, Athens, Greece 
Approved
VIEWS 8
It is a well written manuscript. 
There are some minor comments mentioned below.
- The abstract is complete but the last sentence is confusing. Usually, authors conclude with the aim of the study, which in this case is ... Continue reading
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HOW TO CITE THIS REPORT
Grammatopoulou E. Reviewer Report For: Effect of diaphragmatic stretch technique on thoracic excursion and pulmonary function in COPD patients: Study protocol for randomized controlled trial. [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2024, 13:248 (https://doi.org/10.5256/f1000research.158629.r266535)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

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Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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