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CTRI Number  CTRI/2023/09/057416 [Registered on: 11/09/2023] Trial Registered Prospectively
Last Modified On: 06/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical trial to study the effects of two techniques, myofascial release therapy and chest exercises on functions of the lungs and mobility of the chest wall in individuals with old respiratory condition.  
Scientific Title of Study   Immediate effects of myofascial release therapy and thoracic mobility exercises on lung functions and chest mobility in individuals with chronic obstructive pulmonary disease: An Experimental Crossover Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhruvi Gada 
Designation  Student 
Affiliation  K J Somaiya College of Physiotherapy 
Address  Room number 12, Cardiopulmonary OPD, K J Somaiya College of Physiotherapy, near K J Somaiya Hospital, Ayurvihar complex, Eastern Express Highway, Sion, Mumbai.

Mumbai
MAHARASHTRA
400022
India 
Phone  9930275982  
Fax    
Email  dhruvi.kg@somaiya.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Shweta Manwadkar 
Designation  Principal and Professor 
Affiliation  K J Somaiya College of Physiotherapy 
Address  Principals cabin, K J Somaiya College of Physiotherapy, near K J Somaiya Hospital, Ayurvihar complex, Eastern Express Highway, Sion, Mumbai.

Mumbai
MAHARASHTRA
400022
India 
Phone  8104017576  
Fax    
Email  principal.physiotherapy@somaiya.edu  
 
Details of Contact Person
Public Query  
Name  Dr Shweta Manwadkar 
Designation  Principal and Professor 
Affiliation  K J Somaiya College of Physiotherapy 
Address  Principals cabin, K J Somaiya College of Physiotherapy, near K J Somaiya Hospital, Ayurvihar complex, Eastern Express Highway, Sion, Mumbai.

Mumbai
MAHARASHTRA
400022
India 
Phone  8104017576  
Fax    
Email  principal.physiotherapy@somaiya.edu  
 
Source of Monetary or Material Support  
K J Somaiya College of Physiotherapy, near K J Somaiya Hospital, Ayurvihar complex, Eastern Express Highway, Sion, Mumbai 400022  
 
Primary Sponsor  
Name  Dhruvi Gada 
Address  Room number 12, Cardiopulmonary OPD, K J Somaiya College of Physiotherapy, near K J Somaiya Hospital, Ayurvihar complex, Eastern Express Highway, Sion, Mumbai 400022 
Type of Sponsor  Other [Self] 
 
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 
Dhruvi Gada  K J Somaiya College of Physiotherapy  Room number 12, Cardiopulmonary OPD, K J Somaiya College of Physiotherapy, near K J Somaiya Hospital, Ayurvihar complex, Eastern Express Highway, Sion, Mumbai 400022
Mumbai
MAHARASHTRA 		 9930275982

dhruvi.kg@somaiya.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, K J Somaiya College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Myofascial Release Therapy  The Myofascial Release Therapy will be given by the investigator for 3-5 mins until the fascia feels loose. The standard treatment for the condition will also be given. Total duration for the intervention will be 15-20mins 
Comparator Agent  NIL  NIL 
Intervention  Thoracic Mobility Exercises  The Thoracic Mobility Exercises will be performed for 10 repetitions, 3 sets under supervision. The standard treatment for the condition will also be given. The total duration for the intervention will be 15-20 mins 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a) Participants diagnosed with Chronic Obstructive Pulmonary Disease (COPD)
b) All genders
c) Aged between 40 to 60 years
d) Stable condition for the past month (no exacerbation of symptoms)  
 
ExclusionCriteria 
Details  a)Other Cardiorespiratory disorders (Grade 3 & 4 CCF)
b) Patients who have undergone recent cardiothoracic or abdominal surgery.
c) Patients who have a recent history of chest wall or abdominal trauma; substantial chest wall deformity
d) Dyspnea grade 4 on mMRC scale
e) Known contraindications to myofascial release therapy (malignancy, tumours, Rheumatoid arthritis, osteoporosis)
f) Pregnancy
g) Neuromuscular or musculoskeletal pathology 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a) To evaluate the immediate effect of myofascial release therapy on lung functions & chest mobility in COPD using pulmonary function test (FEV1, FVC, VC, RV, ERV & TLC) & chest expansion measurement by tape method respectively.
b)To evaluate the immediate effect of thoracic mobility exercise on lung functions and chest mobility in COPD using pulmonary function test (FEV1, FVC, VC, RV, ERV and TLC) and chest expansion measurement by tape method respectively.
c) To compare the immediate effects of myofascial release therapy and thoracic mobility exercises on lung functions and chest mobility in COPD. 		 The assessment will be taken before the start of the intervention & immediately after the intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   15/09/2023 
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="6"
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   This trial is an experimental crossover study to compare the effects of Myofascial Release (MFR) technique and Thoracic Mobility Exercises on lung functions and chest mobility in individuals with Chronic Obstructive Pulmonary Disease (COPD). Patients meeting the inclusion criteria will be selected. Pre-treatment assessments of lung functions with pulmonary function test (FEV1, FVC, VC, RV, ERV and TLC) and chest mobility with chest expansion measurement by tape method will be conducted. Each patient will receive one of the interventions, Myofascial Release (MFR) technique and Thoracic Mobility Exercises, along with standard COPD treatment, followed by post-treatment assessments. After a 24-hour washout period, the pre treatment assessment will be done and the second intervention will be administered. Post-treatment assessments will be carried out again. Statistical analysis will determine any significant changes in pre and post assessments of both the interventions. It will also determine any significant differential effect in both the interventions. A cross-over design will allow the patients to experience both interventions sequentially. The study aims to discern the impact of these techniques on lung functions and chest mobility in COPD patients. 
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