Effectiveness of an 8-week community-based pulmonary rehabilitation (PR) program in improving the health-related quality of life among patients with silicosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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
时间窗: 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
次要结局
- 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)
研究者
Dr Rakshit Shah
ICMR - National Institute of Occupational Health