| CTRI Number |
CTRI/2025/09/095364 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| 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
|
Improving Breathing, Balance, and Daily Life through Telerehabilitation in People with COPD |
|
Scientific Title of Study
|
Effect of Telerehabilitation on the Pulmonary Functions, Balance, Cognition and Functional Outcomes among individuals with COPD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Mandeep K Jangra (PT) |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), MULLANA, AMBALA
Ambala HARYANA 133207 India |
| Phone |
9416797708 |
| Fax |
|
| Email |
mandeep.jangra@mmumullana.org |
|
Details of Contact Person Scientific Query
|
| Name |
Mandeep K Jangra |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION |
| Address |
Maharishi Institute of Physiotherapy and Rehabilitation, MM(DU), MULLANA, AMBALA
Ambala HARYANA 133207 India |
| Phone |
9416797708 |
| Fax |
|
| Email |
mandeep.jangra@mmumullana.org |
|
Details of Contact Person Public Query
|
| Name |
Mandeep K Jangra |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION |
| Address |
Maharishi Institute of Physiotherapy and Rehabilitation, MM(DU), MULLANA, AMBALA
Ambala HARYANA 133207 India |
| Phone |
9416797708 |
| Fax |
|
| Email |
mandeep.jangra@mmumullana.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ridhi Vatsa |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana, Ambala, 133207 |
| Type of Sponsor |
Other [Physiotherapy ] |
|
|
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 |
| Ridhi Vatsa |
Respiratory OPD, MMIMSR, Mullana-Ambala |
MM Superspeciality Hospital, MM(DU), Mullana-Ambala Ambala HARYANA |
9876757689
vatsaridhi14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Home Based Pulmonary Rehabilitation |
Patients in Control group will perform the exercises unsupervised and will maintain a log book on daily basis. After 6 weeks, they will report back for comparison of the parameters. |
| Intervention |
Pulmonary Telerehabilitation |
Patients in Experimental group will receive supervised telerehabilitation for 6 weeks. Total duration of the session will be 40 mins. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of COPD with FEV1 more than 50%
Consent to participate
MoCA score more than 25 |
|
| ExclusionCriteria |
| Details |
Neurological Disorders
Any Cardiovascular Disorders
Any Pulmonary Conditions Other than COPD
Musculoskeletal Disorders
Diagnosis of COPD with FEV1 less than 50%
Patient’s Refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
FEV1, FVC, FEV1/FVC
Functional performance and ADL
Cognition
Balance |
FEV1, FVC, FEV1/FVC
Functional performance and ADL
Cognition
Balance |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
06/10/2025 |
| 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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Chronic Obstructive Pulmonary Disease (COPD) is a global health concern with high incidence and mortality rates, largely resulting from airway and alveolar abnormalities that often lead to irreversible airflow limitation. More than 70% of COPD patients are diagnosed at stage 1 or stage 2, as per the GOLD criteria, and may exhibit minimal or no apparent symptoms like exercise limitation and dyspnea. However, these individuals still face significant challenges affecting their physical independence and overall health. Exercise training is a powerful intervention to improve exercise tolerance, skeletal and respiratory muscle function, movement efficiency, dyspnoea and fatigue symptoms, and health-related quality of life. The traditional methods are often ineffective for this population due to barriers such as geographic distance, limited access to healthcare facilities, and financial constraints. The primary pulmonary rehabilitation programs delivered by telerehabilitation can provide a clinically effective alternative to centre-based rehabilitation models. The purpose of this study is to evaluate the effectiveness of telerehabilitation on pulmonary outcomes, balance, cognition, and functional outcomes in individuals with mild to moderate COPD. This research aims to bridge the existing gap by providing insights into functional outcomes and the potential of telerehabilitation to improve Activities of Daily Living (ADL) performance. The findings from this research could provide valuable insights into the role of telerehabilitation in managing COPD, particularly in enhancing daily functional capacity. In this study, individuals with COPD (FEV1 > 50%) aged between 45-80 years will be invited from respiratory medicine for screening purposes. The 60 eligible candidates, as per the eligibility criteria, will be selected, and consent will be procured. Further, they will be divided into two random groups, Group 1 (Experimental Group) will receive telerehabilitation, whereas Group 2 (Control Group) will receive conventional rehabilitation. Participants will undergo a structured pre- and post-test (after 6 weeks) evaluation to assess the impact of telerehabilitation on their pulmonary outcomes, balance, cognition, and functional outcomes. At the baseline and end of the program, the pulmonary outcomes will be measured with the help of RMS Helios 401, functional outcomes using Londrina ADL protocol, cognition with MoCA, and balance using the Berg Balance Scale will be administered. Data collected will be statistically analysed to determine the effectiveness of telerehabilitation. Comparative analysis between pre-and post-test results will be conducted to evaluate improvements in functional performance, and the findings will be used to assess the intervention’s efficacy.
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