| CTRI Number |
CTRI/2026/04/107229 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
05/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two manual physiotherapy techniques,
MFR and MET used with pulmonary rehabilitation in patients with chronic obstructive pulmonary disease |
|
Scientific Title of Study
|
comparative effect of Myofascial release therapy versus Muscle energy technique as an adjunct to pulmonary rehabilitation on respiratory mechanics, functional exercise capacity, and quality of life in chronic obstructive pulmonary disease (COPD)- A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshita Garg |
| Designation |
MPT Student |
| Affiliation |
jamia hamdard university |
| Address |
Room no - 9 Rehabilitation center Jamia Hamdard , hamdard nagar , new delhi- 110062
South West DELHI 110062 India |
| Phone |
8076170531 |
| Fax |
|
| Email |
Lakshita182@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nahid khan |
| Designation |
Assistant professor |
| Affiliation |
jamia hamdard university |
| Address |
Room no -9 Rehabilitation center Jamia Hamdard , hamdard nagar , new delhi- 110062
South West DELHI 110062 India |
| Phone |
9582385008 |
| Fax |
|
| Email |
Nahid0409@jamiahamdard.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Jyoti Ganai |
| Designation |
Assistant professor |
| Affiliation |
jamia hamdard |
| Address |
Room no - 9 Rehabilitation center Jamia Hamdard , hamdard nagar , new delhi- 110062
South West DELHI 110062 India |
| Phone |
9818379267 |
| Fax |
|
| Email |
jyotiganai@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard, Hamdard Nagar , New Delhi - 110062 |
|
|
Primary Sponsor
|
| Name |
JAMIA HAMDARD |
| Address |
Jamia Hamdard , Hamdard Nagar, New Delhi -110062 |
| Type of Sponsor |
Other [self - funded ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nahid Khan |
Department Of Physiotherapy , Jamia Hamdard , Hmadard Nagar , New Delhi - 110062 |
ROOM NUMBER 9 , REHABILITATION CENTER , JAMIA HAMDARD , HAMDARD nAGAR , NEW DELHI- 110062 South West DELHI |
9582385008
Nahid0409@jamiahamdard.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional ethics committee (JHIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (MFR) , Group B (MET) |
Group A: Myofascial Release Technique (MFR) + Pulmonary Rehabilitation
Participants receive myofascial release to the diaphragm, sternocleidomastoid, and scalene muscles in supine lying. Diaphragmatic release is applied below the costal margin using gentle sustained fascial pressure synchronized with slow breathing and prolonged exhalation. SCM and scalene release are performed using sustained manual pressure and breathing coordination, avoiding neurovascular structures. Treatment is provided for 3–5 minutes per muscle group, 4 sessions per week for 4 weeks. Diaphragmatic release is progressed from 5 to 10 deep breaths per set over sessions. All participants also receive standard pulmonary rehabilitation.
Group B: Muscle Energy Technique (MET) + Pulmonary Rehabilitation
Participants receive MET for the diaphragm, SCM, and scalene muscles in supine position. Gentle isometric contractions (20–30% effort) are performed for 5–10 seconds against therapist resistance, followed by relaxation and passive stretching. Each muscle is treated for 2–4 repetitions per session. Diaphragmatic MET is coordinated with deep breathing for 3–5 minutes. Intervention is given along with standard pulmonary rehabilitation for 4 weeks. |
| Comparator Agent |
Group C ( Pulmonary Rehabilitation) |
Participants receive a structured pulmonary rehabilitation program. Lower-limb endurance training includes walking on treadmill using interval methods, performed four days per week for ten to fifteen minutes per session, beginning at sixty to eighty percent of the average six-minute walk test speed and progressed every one to two weeks as tolerated. Upper-limb endurance training using resistance bands is performed for ten to twenty reps, four days per week. Strength training for upper and lower limbs is conducted four days per week with two to three sets of ten to twenty repetitions using progressive resistance. Breathing retraining, including diaphragmatic breathing, pursed-lip breathing, and segmental breathing, is practiced daily. Flexibility exercises are performed daily. Education, self-management strategies, and psychosocial support are provided weekly. Participants are monitored using the Borg dyspnea scale, heart rate, and oxygen saturation, and exercise is paused if oxygen saturation falls below eighty-eight percent. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Participants with diagnosed COPD (Stage II-Stage III)
2 Stable medical condition (no exacerbations in the last three month)
3 Willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
1 History of recent thoracic or abdominal surgery
2 Patients with severe orthopedic problems related to spine, fracture of rib
3 Unstable cardiac condition recent myocardial infarction , cor pulmonale etc.
4 Cognitive impairment preventing study participation
5 Subject participation in yoga, gym activities, and physical fitness training activities
6 Active lung disease which are contraindicated for exercise training , Skin related disorder of upper back and chest
7 Uncontrolled diabetes, uncontrolled hypertension
8 Musculoskeletal disorders affecting movement
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pulmonary Function Tests: FEV1, FVC, FEV1/FVC RATIO, MVV, PEFR
2.Chest Expansion Measurement |
baseline , immediate , 2 weeks , 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Functional capacity
2.dyspnea
3. quality of life
4.thoracic rotation
|
baseline , immediate , 2 weeks , 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The present study is an interventional study. The purpose of the study is to compare the effects of myofascial release therapy and muscle energy technique as an adjuncts to pulmonary rehabilitation on respiratory mechanics , functional capacity and quality of life in COPD. Study will be conducted at Jamia Hamdard , Rehabilitation Centre in New Delhi , India. The aim and objectives of the study are to compare the effects of myofascial release therapy and muscle energy technique as an adjuncts to pulmonary rehabilitation , to assess and compare functional exercise capacity between the three groups using the 6- minute walk test , quality of life using the St. George ’s Respiratory Questionnaire (SGRQ), dyspnea severity using the modified Borg scale. The outcome measures are respiratory mechanics , functional exercise capacity , quality of life. |