| CTRI Number |
CTRI/2025/01/079439 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| 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
|
Evaluating the Impact of Pulmonary Rehabilitation in Patients with Chronic Respiratory Diseases: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Scope of Pulmonary Rehabilitation in Chronic Respiratory Disease Patients- 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 |
KUMARI SULOCHANA |
| Designation |
Research Scholar |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
Department of Respiratory Therapy, Bharati Hospital and Research Centre, Pune Satara Road, Dhankawadi, Pune
Pune
MAHARASHTRA
411046
India |
| Phone |
|
| Fax |
|
| Email |
sulochana.rt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi N |
| Designation |
Professor and Head of Department |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Respiratory Medicine, Chettinad Hospital and Research Institute, Kelambakkam, Chennai
Chennai
TAMIL NADU
600130
India |
| Phone |
9840245981 |
| Fax |
|
| Email |
respiratorymedicine@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Kumari Sulochana |
| Designation |
Research Scholar |
| Affiliation |
Bharati Hospital and Research Centre |
| Address |
Department of Respiratory Therapy, Bharati Hospital and Research Centre, Pune Satara Road, Dhankawadi, Pune
Pune
MAHARASHTRA
411046
India |
| Phone |
9881519089 |
| Fax |
|
| Email |
sulochana.rt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No:225, Department of Respiratory Therapy, Bharati Hospital and Research Centre, Pune-411043
Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
NO SPONSOR |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Kumari Sulochana |
Bharati Hospital and Research Centre |
Room No: 225, Department of Respiratory Therapy, Bharati Hospital and Research Centre, Pune Satara Road, Dhankawadi, Pune-411043, Maharashtra, India
Pune
MAHARASHTRA |
9881519089
sulochana.rt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Medical College Institutional Ethics Committee |
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 |
Home based and tele pulmonary rehabilitation training.
|
Intervention-1: 6 weeks of Home based pulmonary rehabilitation training.
Intervention-2: 6 weeks of Tele-pulmonary rehabilitation training. |
| Comparator Agent |
Institution based pulmonary rehabilitation training |
6 weeks of institution based pulmonary rehabilitation training. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with chronic lung disorders like Asthma, COPD, ILD, Post TB
2. Patients with post-COVID lung parenchymal diseases.
3. Patients enrolled for PR within 1 month but more than 2 weeks of hospital discharge due to exacerbation.
|
|
| ExclusionCriteria |
| Details |
1. Patients who have already completed more than 6 PR sessions before the current intervention.
2. Patients with Active infection like COVID-19, Pneumonia & contraindications for performing PFT.
3. Patients with Recent Acute exacerbation (less than 2 weeks of exacerbation) of COPD or ILD
4. Patients are not consistent with the PR program and attendance is less than 70% of PR sessions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of structured pulmonary rehabilitation programs (PRP) on 6-minute walk distance and health-related quality of life in chronic lung diseases. |
Baseline and after 12 sessions (6 weeks) of PRP. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the effect of structured PRP on dyspnoea progression & fatigue level by modified borg scale.
2. To measure the exercise capacity by using 6MWT.
3. To assess the lung function by spirometry.
4. To identify the barriers and facilitators to PRP in the Indian setup. |
Baseline and after 12 sessions (6 weeks) of PRP. |
|
|
Target Sample Size
|
Total Sample Size="107"
Sample Size from India="107"
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)
|
28/01/2025 |
| 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)
|
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
|
Chronic respiratory diseases, including chronic
obstructive pulmonary disease (COPD), interstitial lung diseases (ILD), bronchiectasis
and chronic asthma, contribute 7% to the global burden of disease affecting
individuals in both developed and developing countries. Chronic respiratory
diseases (CRD) are the third leading cause of death worldwide, and account for
10% of all disability-adjusted life years lost due to disability, it also
represents a significant financial burden for patients, families and society. People with CRD experience repeated need for
hospitalisation, reduced quality of life and life expectancy, poor exercise
tolerance and physical functioning, and increased incidence of anxiety and
depression. Despite its proven effectiveness and
strong scientific endorsement for routine use in obstructive airway diseases,
particularly COPD, and significant benefits in interstitial lung disease,
pulmonary rehabilitation remains underutilised. Strategies to enhance access to
PR are essential. This study aims to evaluate the efficacy of pulmonary
rehabilitation in chronic respiratory disease patients which is carried out in
different setups. |