| CTRI Number |
CTRI/2025/03/081704 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| 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
|
Study on Tele-Rehabilitation versus In-Person Pulmonary Rehabilitation for Lung Disease Patients |
|
Scientific Title of Study
|
TELEREHABILITATION VERSUS CENTRE BASED PULMONARY REHABILITATION IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS: A 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 |
Adila Parveen |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Milllia Islamia |
| Address |
Room no 111, first floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi.
South
DELHI
110025
India
South
DELHI
110025
India |
| Phone |
8587868142 |
| Fax |
|
| Email |
aparveen1@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Nadirah Muneer |
| Designation |
MPT cardio 4 sem |
| Affiliation |
Jamia Milllia Islamia |
| Address |
C/o Dr.Adila Parveen Room no 111, first floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi.
South
DELHI
110025
India
South
DELHI
110025
India |
| Phone |
8587868142 |
| Fax |
|
| Email |
24nadirahmuneer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adila Parveen |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Milllia Islamia |
| Address |
Room no 111, first floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi.
South
DELHI
110025
India
South
DELHI
110025
India |
| Phone |
8587868142 |
| Fax |
|
| Email |
aparveen1@jmi.ac.in |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation sciences, Jamia Millia Islamia, Jamia Nagar , New Delhi-110025 |
|
|
Primary Sponsor
|
| Name |
Centre for physiotherapy and rehabilitation sciences |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi.
South
DELHI
110025
India
Room no 111, first floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi.
DELHI
110025
India |
| Type of Sponsor |
Other [Jamia Millia Islamia,New Delhi-110025] |
|
|
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 Adila Parveen |
Jamia Millia Islamia |
Ground floor,Centre for physiotherapy and rehabilitation sciences, Jamia Millia Islamia,Jamia Nagar, New Delhi-110025
South
DELHI |
8587868142
aparveen1@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Metro ethics review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Community based pulmonary rehabilitation |
Duration of 6 weeks
18 sessions three times a week. |
| Comparator Agent |
Tele Rehabilitation |
Duration of 6 weeks 18 sessions three times a week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Participants must have a definitive diagnosis of idiopathic pulmonary fibrosis based on clinical evaluations, radiological assessments, and histopathological criteria via high-resolution computed tomography (HRCT), pulmonary function tests, following ATS/ERS guidelines and incorporating relevant diagnostic measures (Raghu et al., 2018).
b) Subjects must be at least 18 years of age or older.
c) Participants must be capable of completing a 6MWT/ISWT for functional assessments that indicate sufficient exercise tolerance.
d) Participants should exhibit no significant comorbid conditions that may hinder their involvement in the rehabilitation program, such as severe cardiac issues, uncontrolled diabetes, or recent surgical interventions.
e) Patients must possess the cognitive capacity to comprehend and actively engage in the rehabilitation program.
f) All participants must have the ability to provide written & oral informed consent.
|
|
| ExclusionCriteria |
| Details |
a) Patients experiencing an acute exacerbation of IPF or significant symptom worsening within the past 4 to 6 weeks.
b) Individuals with significant comorbid conditions that could impede participation in the rehabilitation program, including but not limited to severe cardiac diseases, uncontrolled diabetes, or recent major surgeries.
c) Individuals currently enrolled in other clinical trials or rehabilitation programs that may interfere with the outcomes of this study.
d) Conditions that could hinder the use of tele-rehabilitation, including lack of access to necessary technology (e.g., smartphone, computer, internet connection) or inability to navigate these technologies.
e) Showed unwillingness to follow the protocol,
f) Unable to speak and/or understand Hindi/English.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Forced Vital Capacity (FVC)
Forced Expiratory Volume in One Second (FEV1)
FEV1/FVC
RV
TLC
RV/TLC
Diffusing Capacity for Carbon Monoxide (DLCO)
|
At baseline and at 6 six weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
16/03/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
This study will follow a prospective, randomized controlled trial design, recruiting 28 patients with Idiopathic Pulmonary Fibrosis (IPF) from Metro Centre for Respiratory Diseases, Metro Hospitals & Heart Institute in Noida, India. Participants will be randomly assigned to either the Tele-Rehabilitation (TR) group or the Centre-Based Pulmonary Rehabilitation (CBPR) group using computer-generated block randomization. Both groups will undergo a six-week rehabilitation program, with three supervised sessions per week. . Outcome Measures: Pulmonary function Respiratory muscle strength ( Functional capacity . Quality of life (King’s Brief Interstitial Lung Disease - Dyspnea severity (Modified Medical Research Council The intervention will include structured exercise training, breathing techniques, patient education, and psychosocial support. All sessions will be monitored for adherence and safety, with continuous tracking of oxygen saturation, heart rate, and perceived exertion levels. Post-intervention assessments will be conducted using the same baseline outcome measures to evaluate the effectiveness of TR compared to CBPR. |