| CTRI Number |
CTRI/2024/07/071730 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effects of community-based pulmonary rehabilitation (PR) program in improving quality of life of patients with silicosis |
|
Scientific Title of Study
|
Effectiveness of an 8-week community-based pulmonary rehabilitation (PR) program in improving the health-related quality of life among patients with silicosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IIRP-2023-0000219 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakshit Shah |
| Designation |
Scientist B |
| Affiliation |
ICMR - National Institute of Occupational Health |
| Address |
3rd floor, Health Sciences Division, ICMR - National Institute of Occupational Health, Near Raksha Shakti University, Meghaninagar, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9429113289 |
| Fax |
|
| Email |
rakshit.shah@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakshit Shah |
| Designation |
Scientist B |
| Affiliation |
ICMR - National Institute of Occupational Health |
| Address |
3rd floor, Health Sciences Division, ICMR - National Institute of Occupational Health, Near Raksha Shakti University, Meghaninagar, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9429113289 |
| Fax |
|
| Email |
rakshit.shah@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakshit Shah |
| Designation |
Scientist B |
| Affiliation |
ICMR - National Institute of Occupational Health |
| Address |
3rd floor, Health Sciences Division, ICMR - National Institute of Occupational Health, Near Raksha Shakti University, Meghaninagar, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9429113289 |
| Fax |
|
| Email |
rakshit.shah@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India
Email: icmrhqds[at]sansad[dot]nic[dot]in |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India |
| 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 Rakshit Shah |
Pindwara,Swaroopganj |
Pindwara Community Health Center (CHC), Pindwara, Sirohi, SH-62, Sirohi Road, Sirohi District, Rajasthan 307022
AND
Swaroopganj Community Health Centre (CHC), Swaroopganj, Sirohi District, Rajasthan, 307023.
Sirohi
RAJASTHAN |
9429113289
rakshit.shah@icmr.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICMR-National Institute of Occupational Health Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J841||Other interstitial pulmonary diseases with fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
8 week Community-based Pulmonary Rehabilitation program |
A community-based pulmonary rehabilitation (PR) program will be conducted for the silicosis patients recruited at CHC Pindwara (the intervention site), twice-a-week for a total duration of 8 weeks. The community-based PR program will include basic, low-intensity exercises that can be delivered without the use of costly equipment such as treadmills/ cycle ergometers/ dumb-bels, etc. The specific exercises will include low-intensity exercises focusing on breathing, inspiratory muscle training, 6 minute walking, and freehand limb exercises. |
| Comparator Agent |
NIL |
No active intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
We would include adult patients, equal to or more than 18 years age having a definitive diagnosis of silicosis, made by the Pneumoconiosis Board of the Rajasthan government, and residing in the geographic limits of the Pindwara block of Sirohi district of Rajasthan as the study participants. |
|
| ExclusionCriteria |
| Details |
We would exclude the silicosis patients that meet any of the following criteria: 1) those who are not willing to participate (in the assessments/ study intervention), 2) requiring supplemental oxygen therapy, 3) unable to complete the 6-minute walk distance test (patient stops and refuses to continue/ test stopped due to the patient having complaint of chest pain/ intolerable dyspnea), 4) having history of syncope on exertion, 5) history of CVS conditions such as myocardial infarction/ stroke, 6) history of any pulmonary infections such as pneumonia, or tuberculosis in the last 6 weeks, 7) concomitant presence of other lung conditions such as bronchial asthma, pneumothorax, sarcoidosis, bronchiectasis and hypersensitivity pneumonitis, and 8) those unable to follow the commands provided by the investigators/ research team members providing intervention. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome variable will be the health-related quality of life - HRQoL, which would be assessed using the mean or median differences in the pre-post scores of the St. George Research Questionnaire (Total, Symptoms, Activity, and Impact scores), in the intervention and the comparison groups. This would be a continuous variable. The St. George Research Questionnaire (SGRQ) is a standardized tool to assess health-related quality of life and has been validated for use in various chronic respiratory disorders, including restrictive lung diseases such as idiopathic pulmonary fibrosis |
Will be assessed at baseline and at 8 weeks, i.e. after the completion of the study intervention in the intervention group and after 8 weeks of the baseline assessment in the control group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Six minute walk distance time |
8 weeks from baseline |
| Modified Medical Research Council scale grading |
8 weeks from baseline |
| Borg Rating of perceived exertion scale scores |
8 weeks from baseline |
| % Predicted FVC, % Predicted FEV1 |
8 weeks from baseline |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
01/11/2024 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Data will be available from the corresponding author upon a reasonable request
- For how long will this data be available start date provided 01-11-2026 and end date provided 01-11-2096?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Rationale: Silicosis has no cure, and the focus is on improving the health-related quality of life (HRQoL) for affected individuals. Hospital-based pulmonary rehabilitation (PR) programs have shown effectiveness in enhancing the HRQoL for occupational lung disease (asbestosis/silicosis) patients. However, most patients are from the lower socio-economic status and reside in rural areas with limited access to tertiary healthcare facilities. Currently, evidence is lacking in relation to the effectiveness of less physically intensive, community-based PR programs for improving HRQoL of silicosis patients Novelty: This study will generate new evidence, on whether community-based PR programs (which include only basic, low-intensity exercises) are effective in improving the HRQoL of silicosis patients. We wish to determine the effectiveness of the PR program so as to be taken up by health and wellness centers (HWCs) later on. Objective: To determine the effectiveness of an 8-week community-based pulmonary rehabilitation program, on improvement in the health-related quality of life of patients with silicosis. Methods: This quasi-experimental interventional study will enroll 170 silicosis patients, with CHC Pindwara designated as the intervention center and CHC Swaroopganj as the comparison center. Participants in the intervention group will undergo the 8-week PR program, which includes low-intensity exercises focusing on breathing, inspiratory muscle training, walking, and freehand limb exercises. Baseline and post-intervention assessments will be conducted to measure changes in HRQoL, aerobic capacity, perceived dyspnea, and pulmonary function. Expected Outcomes: It is expected that the community-based PR program will significantly improve the HRQoL of silicosis patients. |