| 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 |
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Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Effect of abdominal muscle exercises in patient with COPD
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Scientific Title of Study
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Effect of abdominal muscle exercise on peak expiratory flow rate in patients with COPD-A RANDOMISED CONTROL TRAIL
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| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
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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 |
|
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Source of Monetary or Material Support
|
| 404, Orthopedic physiotherapy department, Dr APJ Abdual Kalam College Of Physiotherapy, Loni, Ahmednagar, Maharashtra, 403736 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
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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 |
|
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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
|
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Peak Expiratory Flow Rate |
week-0 to week-2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
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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
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Brief Summary
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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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