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

Not Applicable

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

Registration Number: CTRI/2024/07/071730

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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