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A clinical trial to study the effects of community-based pulmonary rehabilitation (PR) program in improving quality of life of patients with silicosis

Effectiveness of an 8-week community-based pulmonary rehabilitation (PR) program in improving the health-related quality of life among patients with silicosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071730
Enrollment
250
Registered
2024-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J841- Other interstitial pulmonary diseases with fibrosis

Interventions

Intervention1: 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 (

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 fibrosisTimepoint: 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

MeasureTime frame
Six minute walk distance timeTimepoint: 8 weeks from baseline;Modified Medical Research Council scale gradingTimepoint: 8 weeks from baseline;Borg Rating of perceived exertion scale scoresTimepoint: 8 weeks from baseline;% Predicted FVC, % Predicted FEV1Timepoint: 8 weeks from baseline

Countries

India

Contacts

Public ContactDr Rakshit Shah

ICMR - National Institute of Occupational Health

rakshit.shah@icmr.gov.in9429113289

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026