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CTRI Number  CTRI/2023/01/048950 [Registered on: 12/01/2023] Trial Registered Prospectively
Last Modified On: 21/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of yoga on lung function, physical activity, quality of life, and length of hospital stay in patients with lung (pleural-covering of the lung) disorders  
Scientific Title of Study   Influence of expiratory yoga techniques on respiratory function, physical activity, quality of life, and length of hospital stay in patients with pleural disorders: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shwelita Mehta 
Designation  M.P.T- student 
Affiliation  MGM School of Physiotherapy, MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy, MGM Institute of Health Sciences, MGM Educational Campus, Sector 1, Kamothe, Navi Mumbai-410209, Maharashtra (India)

Raigarh
MAHARASHTRA
410209
India 
Phone  9588438744  
Fax    
Email  mehtashwelita@mgmsopnm.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Bela Agarwal 
Designation  Professor 
Affiliation  MGM School of Physiotherapy, MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy, MGM Institute of Health Sciences, MGM Educational Campus, Sector 1, Kamothe, Navi Mumbai-410209, Maharashtra (India)

Raigarh
MAHARASHTRA
410209
India 
Phone  9819000674  
Fax    
Email  bagarwal@mgmsopnm.edu.in  
 
Details of Contact Person
Public Query  
Name  Bela Agarwal 
Designation  Professor 
Affiliation  MGM School of Physiotherapy, MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy, MGM Institute of Health Sciences, MGM Educational Campus, Sector 1, Kamothe, Navi Mumbai-410209, Maharashtra (India)

Raigarh
MAHARASHTRA
410209
India 
Phone  9819000674  
Fax    
Email  bagarwal@mgmsopnm.edu.in  
 
Source of Monetary or Material Support  
MGM School of Physiotherapy, MGM Institute of Health Sciences, Sector-1, Kamothe, Navi Mumbai 
 
Primary Sponsor  
Name  MGM School of Physiotherapy, MGM Institute of Health Sciences 
Address  MGM School of Physiotherapy, MGM Institute of Health Sciences, MGM Educational Campus, Sector 1, Kamothe, Navi Mumbai-410209, 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 Rajani Mullerpatan  MGM School of Physiotherapy, MGM Institute of Health Sciences  OPD No.55 Physiotherapy Department,2nd floor
Raigarh
MAHARASHTRA 		 9920048476

rajani.kanade@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J90||Pleural effusion, not elsewhere classified, (2) ICD-10 Condition: J920||Pleural plaque with presence of asbestos, (3) ICD-10 Condition: J929||Pleural plaque without asbestos, (4) ICD-10 Condition: J941||Fibrothorax, (5) ICD-10 Condition: J94||Other pleural conditions, (6) ICD-10 Condition: J918||Pleural effusion in other conditions classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Physiotherapy Group  pulmonary rehabilitation 12 weeks with supervised sessions for 2-3 days/week for 20-90 minutes, sessions including breathing exercises, aerobic exercises, and resisted exercises. The number of repetitions will be increased to provide a gradual progression and increase the intensity of training 
Intervention  Yoga Group  12 weeks with supervised sessions for 2-3 days/week for 20- 90 minutes, including breathing exercises, aerobic exercises, and resisted exercises and yoga techniques including Annulom-Vilom, Bhramari, and Kapalbhati. The number of repetitions will be increased to provide a gradual progression and increase the intensity of training. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with pleural effusion treated with or without ICD (J90)
Patients with pleural effusion conditions classified elsewhere (J91)
Patients with pleural plaque with presence of asbestos (J92.0)
Patients with pleural plaque without asbestos (J92.9)
Patients with Fibrothorax (J 94.1)
Patients with other specified pleural conditions (J94.8)
Patients with age 18-65 years
 
 
ExclusionCriteria 
Details  Patients with pleurisy
Patients with multiple segmental fractures of ribs
Patients with highly spread malignant tumors
Patients with tension pneumothorax
Patients with broncho-pleural fistulas
Patients with age > 65 years
Patients with morbidly obese
Patients with other concomitant neurological
Patients with recent trauma or surgery
Patients with cognitive impairment or comprehension deficits that prevented them from following verbal commands.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Pulmonary function test mainly FVC, FEV1will be use to assess respiratory function
2. Maximum inspiratory pressure and maximum expiratory pressure will be use global measures of maximal strength of respiratory muscles.
3. 6-minute walk test will be use to assess cardiopulmonary endurance.
4. IPAQ will be use to assess physical activity.
5. WHOQOL-BREF questionnaire will be use to assess quality of life
6. Length of hospital stay defined as the number of days between hospital admission and discharge
 		 Pre-intervention, at the 6th week of intervention and 12th week of intervention.
 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   16/01/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The aim of the study is to the study effects of expiratory yoga techniques and conventional physiotherapy on respiratory function, physical activity, quality of life, and length of hospital stay. It is a randomized, open-label blinded, parallel-group, active-controlled trial single-center trial where two groups of patients with pleural disorders will be undergoing rehabilitation for 12 weeks. The physiotherapy group will receive pulmonary rehabilitation and the yoga group will receive both pulmonary rehabilitation and expiratory yoga techniques. The primary outcome measures are pulmonary function test, maximal inspiratory and maximal expiratory pressure, 6-minute walk test, IPAQ, WHOQOL-BREF, and length of hospital stay. Knowledge gained from the study will help provide scientific and evidence-based guidelines for patients with pleural disorders to improve respiratory function, physical activity, and quality of life. 
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