| CTRI Number |
CTRI/2025/12/098881 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| 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
|
Online Exercise Training for COPD Lung Health |
|
Scientific Title of Study
|
Telerehabilitation Exercise Training on Pulmonary Function in People with Chronic Obstructive Pulmonary Disease - A Feasibility Randomized Controlled Trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joshua Vivin P |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (DU) |
| Address |
Room no:2, 2nd floor, Faculty of Physiotherapy
Sri Ramachandra Institute of Higher Education And Research
(Deemed To Be University).
Porur, Chennai
Chennai TAMIL NADU 600116 India |
| Phone |
8072047792 |
| Fax |
|
| Email |
joshuavivin007@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mrs Yogeshwari Raman |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (DU) |
| Address |
Room no:3 , 2nd floor, Faculty of Physiotherapy
Sri Ramachandra Institute of Higher Education And Research
(Deemed To Be University).
Porur, Chennai
Chennai TAMIL NADU 600116 India |
| Phone |
9994360164 |
| Fax |
|
| Email |
yogeshwaridinakaran@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Mrs Yogeshwari Raman |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (DU) |
| Address |
Room no:3 , 2nd floor, Faculty of Physiotherapy
Sri Ramachandra Institute of Higher Education And Research
(Deemed To Be University).
Porur, Chennai
Chennai TAMIL NADU 600116 India |
| Phone |
9994360164 |
| Fax |
|
| Email |
yogeshwaridinakaran@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, chennai,Tamilnadu, India 600116 |
|
|
Primary Sponsor
|
| Name |
Joshua Vivin P |
| Address |
Room no:2, 2nd floor, Faculty of Physiotherapy
Sri Ramachandra Institute of Higher Education And Research
(Deemed To Be University).
Porur, Chennai 600116
|
| Type of Sponsor |
Other [Self funded] |
|
|
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 Yogeshwari |
Department of respiratory medicine |
Sri Ramachandra medical Center and hospital,Sri Ramachandra institute of higher education and research Chennai TAMIL NADU |
9994360164
yogeshwaridinakaran@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Confirmed diagnosis of stable COPD as per GOLD criteria (I,II,III)
2)Access to the internet and ability to operate a web-platform
3)Able to complete study procedures and provide consent
|
|
| ExclusionCriteria |
| Details |
1)Pulmonary rehabilitation within last 6 months
2)Uncontrolled hypertension
3)Unstable cardiovascular disease or significant desaturation that would make pulmonary rehabilitation exercise unsafe or prevent program participation.
4)Individuals unable to walk or whose ability to walk safely and independently is significantly impaired due to non-respiratory related conditions and/or cognitive impairment
5)Individuals who are unable to read or use an internet-enabled device or do not have access to the internet at home
6)Unwillingness to participate in pulmonary function test or outcome assessments
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary Function Test (PFT) |
At baseline and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
4 Meter Gait Speed Test
Baseline/ Transition Dyspnea Index
COPD Assessment Test(CAT)
FACIT- Fatigue |
At baseline
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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)
|
21/12/2025 |
| 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="0" Months="5" 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 study is a feasibility randomized controlled trial titled Telerehabilitation Exercise Training on Pulmonary Function in People with Chronic Obstructive Pulmonary Disease. The objective is to evaluate the effect of telerehabilitation exercise training on pulmonary function in COPD patients. Participants will be randomly assigned to either a conventional exercise group or a tele rehabilitation group. The intervention lasts 8 weeks with supervised sessions and home based exercises in both groups. The tele rehabilitation group receives additional weekly video supervised exercise sessions. Primary outcomes include pulmonary function tests, exercise capacity, fatigue, dyspnoea and quality of life measures assessed at baseline and post intervention. Safety adherence and adverse events will be monitored throughout the study aims to establish feasibility safety and clinical benefits of telerehabilitation as a scalable alternative to traditional pulmonary rehabilitation in COPD. |