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CTRI Number  CTRI/2021/11/038308 [Registered on: 29/11/2021] Trial Registered Prospectively
Last Modified On: 31/07/2022
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   The Effect of Exercises for recovery of patients after COVID-19 Infection 
Scientific Title of Study   The Effect of Exercise based Rehabilitation for recovery after post-acute COVID-19 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rachana Shetty BV 
Designation  PhD Scholar 
Affiliation  Srinivas University 
Address  Kengal Hanumanthaiah Institute of Physiotherapy-OPD Unit of KIMS Hospital Srigandhadhakavalu Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9986669780  
Fax    
Email  rachanabvshetty@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Udaya Kumar Maiya 
Designation  PhD Guide 
Affiliation  Srinivas University 
Address  Srinivas Nagar, Mukka, Mangalore

Dakshina Kannada
KARNATAKA
574146
India 
Phone  9845022467  
Fax    
Email  udaya.maiya@srinivasuniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  Rachana Shetty BV 
Designation  PhD Scholar 
Affiliation  Srinivas University 
Address  Kengal Hanumanthaiah Institute of Physiotherapy-OPD A unit of KIMS Hospital Srigandhadhakavalu

Bangalore
KARNATAKA
560091
India 
Phone  9986669780  
Fax    
Email  rachanabvshetty@gmail.com  
 
Source of Monetary or Material Support  
Kengal Hanumanthaiah Institue of Physiotherapy, Srigandhadakavalu, Bangalore-560091 
 
Primary Sponsor  
Name  Rachana Shetty BV 
Address  A301, Brigade Omega, 80 Feet Road, Banashankari 6th Stage, 1st Block, Bangalore-560061 
Type of Sponsor  Other [PhD Research Study- Individual] 
 
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 
Rachana Shetty BV  Kengal Hanumanthaiah Institute of Physiotherapy(Unit of KIMS Hospital)  KHIPT-OPD, Department of Cardiorespiratory Physiotherapy, Srigandhadakavalu, Bangalore-560091
Bangalore
KARNATAKA 		 9986669780

rachanabvshetty@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Srinivas University Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: Z739||Problem related to life managementdifficulty, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Home-based exercise program for post CoVID-19 subjects-Exercise Manual  Exercise Frequency: 3 to 5 sessions weekly for 8 weeks(3 times a week of endurance exercise and 2 days of strength training exercise) Exercise Intensity: By use of modified Borgs Scale 4 to 6 and Talk test Type: Respiratory training, Endurance training and low load-high repetitive strength training Duration: 8 weeks 
Intervention  Home-based exercise program for Post COVID-19 Subjects-Tele rehabilitation  Exercise Frequency: 3 to 5 sessions weekly for 8 weeks(3 times a week of endurance exercise and 2 days of strength training exercise) Exercise Intensity: By use of modified Borgs Scale 4 to 6 and Talk test Type: Respiratory training, Endurance training and low load-high repetitive strength training Duration: 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Post Acute COVID-19 Subjects who are being able to ambulate without assistance or assistive devices and Subjects familiar with use of smart phones/tablets
 
 
ExclusionCriteria 
Details  Resting Heart rate >120 beats/minute, Blood pressure <90/60 mmHg or >140/90 mmHg, Blood oxygen saturation <95%, Unstable Cardiovascular diseases/Pacemakers, Neuromuscular Disorders, Severe Lower limb impairment and Severe Cognitive Impairment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measures of 6 Minute Walk Test (6MWT), Chest expansion measurement and 30 seconds Sit to Stand test(30STST) are used to assess the cardio-respiratory exercise endurance and functional status of the subjects  All the parameters taken prior to intervention would be reassessed at 4 weeks, 8 weeks and 12 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome measures of mMRC-dyspnea scale, Modified Borg RPE Scale and SF- 36 quality of life questionnaire will be used to assess the associated factors like dyspnea, rate of perceived exertion and quality of life  All the parameters taken prior to intervention would be reassessed at 4weeks, 8weeks and 12 weeks of intervention 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
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)   06/12/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 Published Paper titled "The Origin and Consequences of COVID-19 – A Rehabilitative Perspective" in IJARESM (International Journal of All Research Education & Scientific Methods) with Impact Factor: 7.429, Volume 10 Issue 6, June- 2022  
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rachanabvshetty@gmail.com].

  6. For how long will this data be available start date provided 15-02-2024 and end date provided 15-02-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Background:COVID-19 is a multi-system disease that causes impaired lung and physical function, reduced quality of life with emotional distress. It is observed that sequelae of symptoms such as fatigue, muscle weakness, sleep difficulties, anxiety and depression persisted for 6 to 9 months after infection in COVID-19 patients. The persistence of complications following COVID-19 may lead to substantial morbidity as there is no clear plan for the management of such patients.

Multiple symptoms persisting about 3 months after the onset of symptoms in COVID19 patients either in hospitalised or non-hospitalised patients suggested the presence of a “post-COVID-19 syndrome” implying a long term healthcare needs in patients with both “mild” and “severe” COVID-19.

Method:

Group A: Subjects randomised to 8 weeks of home- based exercise program supervised through tele-rehabilitation by using a smart phone/tablet which will be used to facilitate communication through video calls between the therapist and subjects and to share exercise protocol and educational material to the patient.

Group B: Subjects randomised to 8 weeks of home based unsupervised exercise program received through an exercise manual provided at the time of their baseline assessment. They will use the exercise manual to guide through the exercise program.

Outcome:  After doing the baseline assessment of the subjects prior to intervention with exercise based rehabilitation in both groups a staggered follow-up of these groups will be done at 4 weeks, 8 weeks and 12 weeks using the following primary outcome measures of 6 Minute Walk Test (6MWT), Chest expansion measurement and 30 seconds Sit to Stand Test (30STST) to assess the cardio-respiratory exercise endurance and functional status of the subjects. The secondary outcome measures of mMRC- dyspnea scale, Modified Borg Scale and SF-36 quality of life questionnaire will be used to assess the associated factors like dyspnea, rate of perceived exertion and quality of life

 
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