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CTRI Number  CTRI/2024/12/078287 [Registered on: 18/12/2024] Trial Registered Prospectively
Last Modified On: 18/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of abdominal muscle exercises in patient with COPD  
Scientific Title of Study   Effect of abdominal muscle exercise on peak expiratory flow rate in patients with COPD-A RANDOMISED CONTROL TRAIL  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Vikas Patil 
Designation  Associate professor Orthopedic Physiotherapy Dr. APJ Abdual Kalam college of physiotherapy  
Affiliation  Pravara institute of medical sciences  
Address  Dr.APJ Abdual Kalam College Of Physiotherapy Loni Ahmadnagar MAHARASHTRA 413736 India
Pravara institute of medical sciences, Loni,Ahemadnagar, Maharastra, 413746
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8698018840  
Fax    
Email  vaishnavivpatil23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sukhpreet Pabla PT 
Designation  Associate professor Orthopedic Physiotherapy Dr. APJ Abdual Kalam college of physiotherapy  
Affiliation  Pravara institute of medical sciences  
Address  Dr.APJ Abdual Kalam College Of Physiotherapy Loni Ahmadnagar MAHARASHTRA 413736 India
Pravara institute of medical sciences, Loni Ahmadnagar MAHARASHTRA 413736
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9673874879  
Fax    
Email  pablasukhpreet27@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sukhpreet Pabla PT 
Designation  Associate professor Orthopedic Physiotherapy Dr. APJ Abdual Kalam college of physiotherapy  
Affiliation  Pravara institute of medical sciences  
Address  404 Orthopedic physiotherapy department, Dr.APJ Abdual Kalam College Of Physiotherapy Loni Ahmadnagar MAHARASHTRA 413736 India
Pravara Institute Of Medical Sciences Ahmadnagar MAHARASHTRA 413736
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9673874879  
Fax    
Email  pablasukhpreet27@gmail.com  
 
Source of Monetary or Material Support  
404, Orthopedic physiotherapy department, Dr APJ Abdual Kalam College Of Physiotherapy, Loni, Ahmednagar, Maharashtra, 403736  
 
Primary Sponsor  
Name  Dr APJ Abdual Kalam College Of Physiotherapy, PIMS,Loni 
Address  Pravara institute of medical sciences Dr.APJ Abdual Kalam college of physiotherapy ahmadnagar MAHARASHTRA 4137Z 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vaishnavi Patil  Dr APJ Abdual Kalam College Of Physiotherapy Loni Ahmadnagar  Orthopedic physiotherapy department, Dr APJ Abdual Kalam College Of Physiotherapy Loni Ahmadnagar MAHARASHTRA 413736 India
Ahmadnagar
MAHARASHTRA 
08698018840

vaishnavivpatil23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  controlled group-Breathing exercises   Diaphragmatic breathing 5reps/2sets pulsed lip breathing 5reps/2sets glossopharyngeal breathing 5reps/2sets paper blowing5reps/2sets ballon blowing 5reps/2sets 
Intervention  Interventional group Abdominal muscle exercises 2 weeks protocol  Crutches exercises bicycle crutch heel taps scissors Diaphragmatic breathing pulsed lip breathing glossopharyngeal breathing paper blowing ballon blowing 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Both Males and Females.
participants diagnosed with COPD
mild and moderate COPD according to gold criteria.
Ability to perform abdominal exercises
Patients between 30-60 years of age group
 
 
ExclusionCriteria 
Details  recent abdominal or thoracic surgery
Severe cognitive impairment
Inability to understand
Presence of any musculoskeletal or neurological condition
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Peak Expiratory Flow Rate  week-0 to week-2 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   29/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION:

Respiratory muscles are generally classified into two types: Primary or major respiratory muscles and accessory respiratory muscles. Inspiration is an active process. Primary inspiratory muscles are Diaphragm, External intercostal, interconal part of internal intercostal muscles. Accessory muscles include sternocleidomastoid, scalene, upper trapezius, and pectoralis major and minor. At rest, expiration is passive process and achieved through the elastic recoil of the lung and thoracic cage but during forceful expiration additional muscles can be used, are abdominals. The abdominal muscles include Rectus abdominis, external oblique, internal oblique, transverse abdominis. They are regarded as powerful expiratory muscles. It is suggested that expiratory muscles are prone to fatigue that subsequently impairs pulmonary function. Now-a-days as the lifestyle and pollution has direct impact on respiratory system even for normal individuals, the demand will place a greater emphasis on maximizing the patient’s independence, minimizing the disabilities and increasing the patient’s functional status so their quality of life may improve. Respiratory muscle training has effects on pulmonary function and physical performance in both healthy and cardiopulmonary disease populations. Also, non-respiratory maneuvers have been found to activate the diaphragm to varying degrees depending on type of exercise. Abdominal muscle strengthening exercises may be useful in increasing abdominal muscle endurance, also pulmonary functions

Aim of the study is to discover how abdominal exercises affect the Peak Expiratory Flow Rate (PEFR) in COPD patients.

NEED FOR THE STUDY: Abdominal muscle strengthening exercise is safe and beneficial for any normal individual. Which can improve peak expiratory flow rate which improves quality of life. As studies have in been conducted in normal healthy individuals and in females but not in COPD patients coming to rural hospital, so this study will show the effect of  abdominal muscle exercise on peak expiratory flow rate in patients with COPD coming to rural hospital.

 

AIM:  To check the effect of abdominal muscle exercise on peak expiratory flow rate in patients with COPD coming to rural hospital

OBJECTIVE OF THE STUDY:  To increase Peak Expiratory Flow Rate through abdominal muscle strengthening exercises in COPD patients.

REVIEW OF LITERATURE:

1)          Vidhi D. Thakkar et al (2023):  This study suggests that individuals may benefit from performing non respiratory activities such as upper and lower abdominal muscle exercise that can be clinically implied to improve respiratory parameters, cough mechanism and in cardiovascular rehabilitation program.  The study concludes that, there is statistically improvement in PEFR and abdominal muscle endurance after four weeks of abdominal muscle exercises in healthy females. The Improvement was also clinically significant. Thus, the present study accepts the experimental hypothesis and reject the null hypothesis

2)     Shweta Modi et al (2021):  The study was carried out to know the effect of abdominal muscle exercises on Peak Expiratory Flow Rate in middle age females. The result from the statistical analysis of the present study found that there is a beneficial effect of peak expiratory flow rate on the subjects treated with abdominal muscle strengthening exercises. The mean values of data from present study indicates that subjects showed better peak expiratory flow rate after 15 days of abdominal strengthening exercises. The increase in peak expiratory flow rate is most likely due to the abdominal muscles’ facilitator function, which improves the diaphragm’s ability to produce pressure during respiration. This study concludes that abdominal muscle exercises are beneficial in improving peak expiratory flow rate in middle age females. Hence, regular abdominal muscle strengthening exercises can be done to improve strength of abdominal muscles which in turn help in forceful expiration which can be beneficial in clearing cough out of airways, enhancing cough reflex thereby improving quality of life of individuals.

3)     Ishida H et al (2014):  The purpose of this study was to determine whether forced expiration is correlated with abdominal muscle thickness. Twenty-three healthy male volunteers participated in this study. The peak expiratory flow (PEF) was obtained using a peak flow meter with subjects in the sitting position. The thicknesses of the right rectus abdominis, external oblique, internal oblique, and transverse abdominis muscles were measured using B-mode ultrasonography at the end of a relaxed expiration in the supine position. The results show that among the abdominal muscles, only the thickness of the external oblique muscle displayed a significant correlation with PEF. The study concludes that  the thickness of the external oblique muscle might be associated with PEF during forced expiration[3]

4)     Bijal pasad et al (2020):  The purpose of this study was to find the effect of abdominal muscle exercises on peak expiratory flow rate in obese individuals. 4 weeks of abdominal strengthening protocol was given to obese subjects who had a decrease in peak expiratory flow rate. The sample consisted of 20 obese individuals. Prior to the abdominal muscle exercises the peak expiratory flow rate was noted and then after 4 weeks again the peak expiratory flow rate was recorded. The study concluded that there is significant effect of abdominal muscle exercises on peak expiratory flow rate in obese individuals.[4]

5)     Kedar KV et al (2017):   This a study on the effect of menopause on pulmonary functions. It concludes that as menopause sets in, decrease in hormonal levels leads to decreased lung capacity as evident by pulmonary function tests. Decreased pulmonary function test can be attributed to lower levels of sex hormones estrogen and progesterone in postmenopausal women. The predicted values of PEFR were lower in postmenopausal women compared with premenopausal women.[5]


RESEARCH QUESTION: What will be the effect of abdominal muscle exercise on peak expiratory flow rate in patients with COPD ?

HYPOTHESES

Null Hypothesis (H0): There will be no significant effect of  abdominal muscle exercise on peak expiratory flow rate in patients with COPD .

Alternative Hypothesis (H1):  There will be a significant  effect of abdominal muscle exercise on peak expiratory flow rate in patients with COPD .

METHODOLOGY:

SOURCE OF DATA: Samples will be collected from Pravara Rural Hospital , Loni.

STUDY SETTING: Study will be conducted in the in -patient department of cardiorespiratory physiotherapy at Dr. APJ Abdul Kalam College of Physiotherapy.

STUDY TYPE: Interventional study.  

DURATION OF THE STUDY: 1 Year

SAMPLE SIZE: 30

STUDY POPULATION: COPD patients in rural setup

MATERIAL TO BE USED: 1) Peak expiratory flow meter

Inclusion criteria:

1.     Both Males and Females.

2.     participants diagnosed with COPD

3.     mild and moderate COPD according to gold criteria.

4.     Ability to perform abdominal exercises

5.     Patients between 30-60 years of age group.

   Exclusion criteria :                          

1)     recent abdominal or thoracic surgery

2)     Severe cognitive impairment

3)     Inability to understand

4)     Presence of any musculoskeletal or neurological condition

Outcome Measures:  Peak Expiratory Flow Rate.

PROCEDURE:

·       Ethical clearance will be obtained from the institute.

·       A total no of 30    individuals will be a part of this study. The age criteria being yearsl

·       A written informed consent will be obtained from the participants.

·       Randomly assign participants with two group

·       Grup A will be having abdominal exercise and group B will having conventional exercise

·       Group A participant will be explained the technique of performing the abdominal strengthening exercises.

·       Group B will be having exercise such as Breathing Exercises: Incorporating breathing exercises such as pursed lip breathing and diaphragmatic breathing can help COPD patients improve their breathing mechanics and increase lung capacity. Low-Impact Aerobic Exercises: Activities such as walking, stationary cycling, and swimming are generally well-tolerated by COPD patients.

·       Peak Expiratory Pre intervention Flow Rate will be measured using Wright’s Peak Flow Meter of both group.

·       Participants will be asked to perform the test three times, out of them, the best of three trials will be recorded as reading.

·       Patients will be asked to perform abdominal Strengthening Exercises- Upper Abdominals.

·       Exercises will be performed for 1week

·       Post intervention Peak Expiratory Flow Rate will be measured again and recorded.

·       Systemically record data, including exercise adherence, and relevant patient feedback      

·        At the end result obtain by mean difference between [post -pre] of PEFR values.

REFFERENCES-

1)     Vidhi D. Thakkar, Sweety Shah. Effect of abdominal muscle exercise on peak expiratory flow rate in normal healthy female individuals. Int J Health Sci Res. 2023; 13(4):1-12.

2)     Modi S, Shah S. Effect of abdominal curls on peak expiratory flow rate (PEFR) in middle age females. Int J Health Sci Res. 2021; 11(5): 62-66.

3)     Ishida H, Kobara K, Osaka H, Suehiro T, Ito T, Kurozumi C, Watanabe S. Correlation between Peak Expiratory Flow and Abdominal Muscle Thickness. J Phys Ther Sci. 2014 Nov;26(11):1791-3. doi: 10.1589/jpts.26.1791. Epub 2014 Nov 13. PMID: 25435702; PMCID: PMC4242957.

4)     Bijal pasad, Anagha palkar, Ajay kumar. Effect of abdominal muscle exercises on peak expiratory flow rate in obese individuals. Int j physiotherapy res 2020;8(4):3521-3525.

5)     Kedar KV, Munje RP, Karia AK. Effect of Menopause on Pulmonary Functions: An Analysis!. J South Asian Feder Menopause Soc 2017; 5 (2):99-101.

 
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