| 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
|
|
|
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
|
|
|
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. |