Immediate and Three-Month Effects of a Pulmonary Rehabilitation Program in Patients With Post-Tuberculosis Lung Disease: A Prospective Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Change From Baseline in EUROHIS-QOL-8 Total Score
研究概览
简要总结
Post-tuberculosis lung disease (PTLD) refers to persistent respiratory symptoms, functional limitation, and/or structural or physiological abnormalities after completion of anti-tuberculosis treatment. These consequences can reduce exercise capacity and quality of life. This randomized controlled study will evaluate whether an individualized pulmonary rehabilitation program provides greater and more sustained improvement than standard care in adults with PTLD. Participants will be allocated in a 1:1 ratio to an 8-week supervised pulmonary rehabilitation program plus standard care or to standard care alone. Assessments will be performed at baseline (T0), immediately after the 8-week program (T1), and 3 months after program completion (T2; Week 20). The primary outcome will be the change in St George's Respiratory Questionnaire total score from baseline to Week 20. Secondary outcomes will include exercise capacity, mobility, dyspnea, perceived exertion, additional quality-of-life measures, blood-cell-derived inflammatory indices, adherence, and adverse events.
详细描述
Persistent impairment after successfully treated pulmonary tuberculosis is increasingly recognized as an important source of chronic respiratory morbidity. Patients may experience dyspnea, exercise intolerance, fatigue, impaired mobility, and reduced health-related quality of life. Preliminary retrospective data from 37 patients suggested that structured pulmonary rehabilitation may improve the 6-minute walk distance, Timed Up and Go performance, dyspnea, perceived exertion, quality of life, and selected inflammatory indices. However, retrospective allocation and the absence of a longer follow-up limit causal interpretation.
The present study is designed as a prospective, assessor-blinded, parallel-group randomized controlled trial. It will assess both the immediate response to an individualized rehabilitation program and the maintenance of benefit three months after the supervised program has ended. The intervention combines aerobic training, resistance training, breathing exercises, education, and individualized symptom-management strategies. The control group will receive usual post-tuberculosis medical care and general physical-activity advice without a structured supervised pulmonary rehabilitation program during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age 18 years or older.
- •Documented history of pulmonary tuberculosis with anti-tuberculosis treatment completed according to national standards.
- •No clinical evidence of active or relapsed tuberculosis at enrollment; microbiological reassessment will be performed when clinically indicated.
- •Persistent respiratory symptoms, exercise limitation, or functional impairment considered attributable to post-tuberculosis lung disease.
- •Clinical stability for at least 4 weeks before randomization, with no acute respiratory infection or acute exacerbation requiring treatment change.
- •Ability to walk independently, with or without a usual assistive device, and to perform the study assessments.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •• Suspected or confirmed active, recurrent, or drug-resistant tuberculosis requiring treatment or isolation.
- •Acute respiratory infection or acute cardiopulmonary decompensation within 4 weeks before enrollment.
- •Unstable angina, recent myocardial infarction, uncontrolled arrhythmia, decompensated heart failure, severe uncontrolled hypertension, or another contraindication to exercise testing/training.
- •Severe neurological, musculoskeletal, or cognitive impairment that prevents safe participation or valid outcome assessment.
- •Current participation in another structured pulmonary rehabilitation or supervised exercise program.
- •Planned major surgery or another condition likely to prevent completion of the 20-week follow-up.
- •Any condition judged by the investigator to make participation unsafe or to substantially interfere with interpretation of the outcomes.
结局指标
主要结局
Change From Baseline in EUROHIS-QOL-8 Total Score
时间窗: Baseline, Week 8, and Week 20.
Generic quality of life will be assessed using the EUROHIS-QOL-8 questionnaire. The questionnaire contains eight items scored from 1 to 5. The total score ranges from 8 to 40, with higher scores indicating better quality of life. A positive change indicates improvement.
Change From Baseline in St George's Respiratory Questionnaire Total Score at Week 20
时间窗: Baseline to Week 20, corresponding to three months after completion of the 8-week pulmonary rehabilitation program.
Respiratory health-related quality of life will be assessed using the St George's Respiratory Questionnaire (SGRQ). The total score ranges from 0 to 100, with higher scores indicating greater impairment. The outcome will be calculated as the Week 20 score minus the baseline score. A negative change indicates an improvement in respiratory health-related quality of life.
次要结局
未报告次要终点
研究者
Diana Kamal
PhD
Filantropia Hospital