PULMONARY REHABILITATION TO REDUCE POST-TUBERCULOSIS MORBIDITY (TB PURE)-A RANDOMISED MULTI-CENTRE TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 690
- 试验地点
- 2
- 主要终点
- 6MWT
研究概览
简要总结
| Title: |
Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PuRe)
|Population:
690 adults with drug-sensitive pulmonary tuberculosis (TB) with impaired functional status at study enrollment
|Intervention:
8 weeks (short arm) or 24 weeks (extended arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques
|Objectives**:**
1. To compare the effectiveness of two home-based PR programs, administered during TB treatment, for preventing post-TB respiratory morbidity.
2. To describe the intersection between clinic-level service organization, fidelity of intervention delivery, and change in client behavior for the two PR programs.
3. To compare the costs, cost-effectiveness, and budget impact of the two different PR strategies implemented as a routine program.
|Design/Methodology:
Individual-level, unblinded randomized controlled trial of an 8-week (short arm) or 24-week (extended arm) pulmonary rehabilitation program, relative to standard of care, to prevent post-tuberculosis respiratory morbidity. Randomization will occur in a 1:1:1 ratio at the initiation of treatment.
|Primary Outcome:
Mean 6-minute walk test distance compared between the three study arms at 48 weeks after enrollment
|Total Study Duration:
5 years
|Subject Participation Duration:
48 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Microbiologically confirmed (smear microscopy, GeneXpert or culture) pulmonary TB disease.Participants with just smear microscopy results will be enrolled provisionally to stay within the window of enrollment.
- •Thereafter, if the culture results indicate drug resistance, the participant will be offered the opportunity to participate in follow-up visits, can continue with the intervention, but the data will not be considered in the final analysis.
- •Not completed more than 2 weeks of TB treatment Receiving TB care at the outpatient clinics at the TB PuRe study sites Willingness to complete 48 weeks of study evaluations.
- •Access to a smartphone.
排除标准
- •Modified Medical Research Council score of 0 points (dyspnea only with strenuous exercise) Multi or extensively drug-resistant TB disease.
- •Extrapulmonary TB disease at any clinical sites without pulmonary involvement TB meningitis or TB of the spine Symptomatic cardiovascular disease, including coronary artery disease, arrhythmias and congestive cardiac failure.
- •Karnofsky Score < 40 points Any medical condition that prevents pulmonary rehabilitation eg: fracture of lower/upper limbs/pregnancy Bronchodilators and/or corticosteroids inhaled or otherwise.
结局指标
主要结局
6MWT
时间窗: Mean distance compared between study arms at 48 weeks after enrollment
Population:
时间窗: 690 adults with drug-sensitive pulmonary tuberculosis (TB) with impaired functional status at study enrollment
Intervention:
时间窗: 8 weeks (short arm) or 24 weeks (extended arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques
Objectives :
时间窗: 1. To compare the effectiveness of two home-based PR programs, administered during TB treatment, for preventing post-TB respiratory morbidity. 2. To describe the intersection between clinic-level service organization, fidelity of intervention delivery, and change in client behavior for the two PR programs. 3. To compare the costs, cost-effectiveness, and budget impact of the two different PR strategies implemented as a routine program.
Design/Methodology:
时间窗: Individual-level, unblinded randomized controlled trial of an 8-week (short arm) or 24-week (extended arm) pulmonary rehabilitation program, relative to standard of care, to prevent post-tuberculosis respiratory morbidity. Randomization will occur in a 1:1:1 ratio at the initiation of treatment.
Primary Outcome:
时间窗: Mean 6-minute walk test distance compared between the three study arms at 48 weeks after enrollment
Total Study Duration:
时间窗: 5 years
Subject Participation Duration:
时间窗: 48 weeks
次要结局
- 6 Minute walk test(Mean 6MWT distance compared between study arms at 8 16 and 24 weeks after enrollment)
- SGRQ mMRC CRQ CAT scores(Total and sub-domain questionnaire scores compared between study arms at 8 16 24 48 weeks after enrollment)
- Lung function(FEV1 and FVC)