FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 
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  
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  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 â€œheterogeneous 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.

 
Close