| CTRI Number |
CTRI/2025/02/080556 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Muscle energy technique (MET) for respiratory muscles on maximum voluntary ventilation(MVV) in chronic obstructive pulmonary disease (COPD) patients. |
|
Scientific Title of Study
|
Effect of muscle energy technique (MET) for respiratory muscles on maximum voluntary ventilation (MVV) in Chronic obstructive pulmonary disease (COPD) patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gouri Bhoyar |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus
Nagpur MAHARASHTRA 441110 India |
| Phone |
09511830433 |
| Fax |
|
| Email |
bhoyargouri@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shweta Panchbudhe |
| Designation |
Associate professor |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus
Nagpur MAHARASHTRA 441110 India |
| Phone |
9049169589 |
| Fax |
|
| Email |
Shweta12panchbudhe@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
gouri bhoyar |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus
Nagpur MAHARASHTRA 441110 India |
| Phone |
09511830433 |
| Fax |
|
| Email |
bhoyargouri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalinitai Meghe Hospital and Research centre, Ward no. 10
Wanadongri, Nagpur 441110 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy |
| Address |
wanadongri hingna road nagpur 441110 Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Gouri Bhoyar |
Shalinitai Meghe Hospital and Research Centre |
Ward No. 10 respiratory ward Shalinitai Meghe Hospital and Research Center
Wanadongri, Hingna, Nagpur
441110 Nagpur MAHARASHTRA |
09511830433
bhoyargouri@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
|
|
|
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 |
Conventional physiothearpy |
Diaphragmatic breathing exercises ,Chest expansion exercises, upper limb and lower limb endurance exercises and (10 reps, 3 sets, twice a day) are included in the intervention. |
| Intervention |
Muscle energy Technique |
Diaphragmatic breathing exercises ,Chest expansion exercises, upper limb and lower limb endurance exercises and (10 reps, 3 sets, twice a day) for 20 minutes are included in the intervention. MET with conventional pulmonary rehab will be given to patients thrice a week for 1 week.The operators localisation of the joint/muscle barrier (controlled joint positioning), The patient actively contracts their muscles for a predetermined amount of time in a predetermined direction; A unique counterforce was applied by the operator to prevent the patient from contracting, Patient relaxation, Re-uptake of the "new" barrier by the operator (passive muscle stretching or increased joint movement in a particular direction), Carry out the process multiple times. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
84.00 Year(s) |
| Gender |
Both |
| Details |
1 Participants with mild to moderate COPD exacerbation
2 Participants with FEV1/FVC less than 0.70
3 Oxygen saturation greater than 95 percentage |
|
| ExclusionCriteria |
| Details |
1 severe COPD exacerbation
2 recent thoracic and abdominal surgery
3 scoliosis
4 pneumonia
5 haemothorax
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maximum Voluntary Ventilation |
Day 1
Day 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oxygen saturation
Chest expansion |
Day 1
Day 6 |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
03/03/2025 |
| 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
|
Chronic Obstructive Pulmonary Disease (COPD) is a “heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration, exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction. Muscle Energy Techniques (MET) are a form of soft-tissue, or joint, manipulations or mobilizations, deriving from those employed in the treatment of musculoskeletal dysfunction, where the patient participates actively in the treatment (through isometric and/or isotonic contractions). The study aims to investigate the effect of muscle energy technique for muscles aiding in breathing on maximum voluntary ventilation (MVV) in patients diagnosed with COPD. The study includes group control group and interventional group. Control group recieved conventional Physiotherapy and the interventional group was intervened with Muscle energy technique for respiratory muscles for 1 week. Participants diagnosed with COPD and vitally stable will be included in the study. Participants will be assessed pre and post-intervention via an assessment form; also written consent will be signed. Participants would be assessed on day 1 and reassessed on day 6. Post-intervention statistical analysis would be done and results would be extracted to evaluate the efficacy of intervention. |