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CTRI Number  CTRI/2025/07/091027 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Feasibility of developing a tailored rehabilitation programme to reduce the respiratory symptoms of Long COVID in rural Tamil Nadu. 
Scientific Title of Study   Feasibility of a tailored Pulmonary Rehabilitation program to improve functional capability and reduce breathlessness among a cohort of Long COVID patients with respiratory symptoms in rural Tamil Nadu: an implementation trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Paul Jebaraj 
Designation  Training Officer 
Affiliation  Christian Medical College, Vellore 
Address  Room No 7, 1st Floor, Admin Block, RUHSA Department, Christian Medical College, Melkavanur, K.V.Kuppam Block

Vellore
TAMIL NADU
632209
India 
Phone  9629042504  
Fax    
Email  paul.jebaraj@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Biswajit Paul 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Room No 3, Ground Floor, Admin Block, RUHSA Department, Christian Medical College, Melkavanur, K.V.Kuppam Block

Vellore
TAMIL NADU
632209
India 
Phone  8124034755  
Fax    
Email  drbpaul@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Biswajit Paul 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Room No 3, Ground Floor, Admin Block, RUHSA Department, Christian Medical College, Melkavanur, K.V.Kuppam Block

Vellore
TAMIL NADU
632209
India 
Phone  8124034755  
Fax    
Email  drbpaul@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Global Challenges Research Fund, Scottish Funding Council, Apex 2, 97 Haymarket Terrace, Edinburgh, United Kingdom (UK), Pincode - EH12 5HD 
 
Primary Sponsor  
Name  Global Challenges Research Fund, Scottish Funding Council  
Address  Apex 2, 97 Haymarket Terrace, Edinburgh, Postal code: EH12 5HD 
Type of Sponsor  Government funding agency 
 
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 Paul Jebaraj  RUHSA Department, Christian Medical College, Vellore  Room no 1, RUHSA Campus, Christian Medical College, Melkavanur, K.V.Kuppam Block Vellore, Pincode - 632 209
Vellore
TAMIL NADU 
09629042504

paul.jebaraj@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, Christian Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: U071||COVID 19 virus identified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Long COVID tailored Pulmonary Rehabilitation (PR) Intervention (Long COVID-T-PR)  The Long COVID-T-PR group will receive exercise training and educational session for 8 weeks in RUHSA PR Center. The PR sessions will be provided weekly twice for 8 weeks at RUHSA PR Centre. PR will be delivered in groups of 6-8 members. Sessions will last up to two hours and will include exercise components and group education. It will be a rolling programme, so that participants can be allocated to a session within 2-weeks of being randomised to Long COVID-T-PR.  
Comparator Agent  Routine Care   Participants in the routine care will be trained on breathing exercises and provided with education materials on breathing problems during the first visit post randomization in RUHSA hospital. Routine care and management of any co-morbid conditions will be provided through RUHSA hospital. Participants in the routine care group will be offered Long COVID-T-PR at the end of the trial (3-months post randomization).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Participants from the prevalence study with confirmed respiratory symptoms with or without respiratory structural and functional abnormality.
2. Participants with FEV1/FVC less than 0.7 in post bronchospirometry.
3. Participants with modified Medical Research Council Dyspnoea Scale (mMRC) greater than or equal to 2
4. Participants with checklist Individual Strength (CIS)-fatigue greater than or equal to 36
5. Participants with post-COVID-19 Functional Status (PCFS) greater than or equal to 2. 
 
ExclusionCriteria 
Details  1. If they have a known or self-reported cognitive, hearing, visual, neurological or musculoskeletal conditions that preclude participation in PR.
2. Any diagnosis of angina pectoris, recent myocardial infarction, severe pulmonary hypertension, congestive heart failure, unstable diabetes.
3. Inability to do exercise due to orthopaedic or other reasons.
4. Psychiatric illness.
5. Severe exercise-induced hypoxemia, not correctable with O2 supplementation
6. Unwilling to give consent 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Endurance shuttle walking test (ESWT) to measure exercise capacity.   0 - Baseline
10 - 12 weeks - Endline 
 
Secondary Outcome  
Outcome  TimePoints 
1. St Georges Respiratory Questionnaire (SGRQ)
2. MRC Dyspnoea Scale (mMRC)
3. Hospital Anxiety and Depression Score (HADS)
4. London Chest Activities of Daily Living (LCADL)
5. Internation Physical Activity Questionnaire (IPAQ) 
0 - Baseline
10 - 12 weeks - Endline 
 
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   Phase 3 
Date of First Enrollment (India)   01/07/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2026 
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)   Not Yet Recruiting 
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  

The COVID-19 pandemic in 2020 has affected more than 775 million people and has resulted in more than 4 million deaths globally (1). A significant proportion of COVID-19 survivors have reporting persistent general fatigue, and on-going respiratory (dyspnea, cough, throat pain) and non-respiratory related symptoms [neurological symptoms (i.e., headaches, anosmia or ageusia), gastrointestinal symptoms (i.e., diarrhea or vomiting) or dermatological disorders (i.e., hair loss, skin rashes)] following COVID-19 infection (2). The literature on post-COVID symptoms is still in its early stages but post-COVID sequelae causes a considerable burden on the individual health, health systems and the economy worldwide (3). This study aims to identify the prevalence of persistent COVID-19 symptoms among a cohort of COVID-19 survivors after five years of infection and to test the feasibility of a tailored pulmonary rehabilitation program among those with Long COVID in a low-resource limited setting.

Objectives

1. To identify the prevalence of persistent COVID-19 symptoms among a cohort of COVID-19 survivors after five years of SARS-CoV-2 infection in two rural blocks of Tamil Nadu.

2. To systematically review the literature to identify the effective components, and delivery of pulmonary rehabilitation for Long COVID patients in low-resource settings.

3. To develop, with stakeholders, a tailored pulmonary rehabilitation intervention for people with persistent symptoms due to Long COVID.

4. To test the feasibility of tailored pulmonary rehabilitation among Long COVID patients affected by post-COVID-19 respiratory symptoms in a low resource rural setting.

The prevalence of persistent COVID-19 symptoms among a cohort of COVID-19 survivors after five years of SARS-CoV-2 infection will be identified through a cross-sectional survey using standardized questionnaires in K.V. Kuppam and Gudiyatham block. List of COVID-19 positive patients (above 18 years of age) in K.V.Kuppam and Gudiyatham block during the first and second wave will be obtained from Vellore district health office (after prior permission from the Directorate of Public Health & Preventive Medicine, Chennai, Tamil Nadu). A complete line listing of the positive patients from March 2020 to June 2021 will be prepared and with the help of field workers participants will be identified by the PhD Student (researcher).

The researcher will contact the study participants and provide the information of the study. Participants willing to provide consent will be screened using the study tools and cardiorespiratory parameters in their homes. The process for diagnosing Long COVID will be done based on the evaluation of symptoms, time points of symptoms appearance and exclusion of other conditions through the Post COVID-19 symptoms checklist. And those identified with one or more persisting COVID-19 symptoms at the time of the survey will be referred to the nearby secondary care hospital for further diagnosis and treatment. The prevalence of Long COVID will be estimated in percentage and a timeline of symptoms will be recorded during the interview and plotted on a graph.

Long COVID participants with respiratory symptoms from the cross-sectional survey will be referred to secondary care hospital where the physician will complete a diagnose and refer for further investigations such as spirometry (inspiratory and expiratory lung volumes), blood tests and chest x-ray as a part of standard clinical examination. Eligible participants will be referred to the researcher for providing information on the study and to obtain consent. Following consent, the participants will be complete the baseline measurement. A two - arm, single site, individually randomised pragmatic clinical trial will be conducted to evaluate Long COVID tailored Pulmonary Rehabilitation (Long COVID-T-PR) compared to a usual care (UC) for Long COVID patients with respiratory symptoms in low-resource settings.

 
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