Paediatric Post-TB Home-based Pulmonary Rehabilitation Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adherence rate
研究概览
简要总结
The goal of this clinical trial is to learn if a home-based pulmonary rehabilitation program is feasible and acceptable for children ages 6-15 who have recently completed treatment for pulmonary tuberculosis. The main questions it aims to answer are:
Can children and caregivers follow a 6-week rehabilitation program?
Is the program acceptable and feasible for children and caregivers?
Researchers will also explore preliminary changes in walking distance and quality of life.
Participants will:
Attend a clinic visit for baseline testing, including a 6-minute walk test (6MWT) and the St. George's Respiratory Questionnaire (SGRQ)
Receive exercise instructions and a pedometer
Complete home-based walking and wall sit exercises twice per week for 6 weeks
Receive weekly follow-up from study staff (by phone or home visit)
Return to clinic at 6 weeks for follow-up testing
详细描述
An estimated 1.3 million children worldwide develop active tuberculosis (TB) annually, with pulmonary TB being the most common form. Even after successful treatment, children may experience persistent respiratory symptoms and long-term structural and functional lung damage, referred to as post-TB lung disease (PTLD). In Uganda, a high-burden TB and HIV country, the burden of PTLD in children is increasingly recognized, yet evidence-based management strategies are lacking.
PTLD can lead to significant impairments in lung function, exercise capacity, and quality of life. In a recent cross-sectional study conducted by the investigators, Ugandan children aged 6-16 years who had completed TB treatment were more likely to have abnormal lung function, radiographic abnormalities (e.g., fibrosis, pleural thickening), and reduced quality of life compared to household controls.
Pulmonary rehabilitation, a structured program of aerobic and strength exercises, has been shown to improve outcomes in adults with chronic lung disease, including PTLD, but has not been adapted or evaluated in children. This is particularly true in low-resource settings where facility-based programs are often inaccessible.
This single-arm feasibility study will assess the delivery of a 6-week home-based pulmonary rehabilitation program among children aged 6-17 years with previously diagnosed PTLD in Uganda. Participants will be recruited from an existing observational cohort or referred by clinicians based on prior TB history and persistent respiratory impairment. The program includes twice-weekly walking and strength exercises supervised by caregivers, guided by physiotherapy assessment. Weekly monitoring will be conducted through phone calls or home visits, and participants will track their activity using a pedometer and an exercise workbook.
The primary focus is to evaluate whether this intervention can be feasibly implemented in a pediatric population in a low-resource context and to inform the design of a future randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6-17 years
- •Previously diagnosed with post-TB lung disease,
- •Willing to remain in the study catchment area during the study period
- •Able to participate in mild-to-moderate physical activity (late inclusion criterion)
排除标准
- •Currently participating in another rehabilitation program
- •Residence outside the Kampala metropolitan area
- •Active respiratory infection (late exclusion criterion)
结局指标
主要结局
Adherence rate
时间窗: 6 weeks
Proportion of prescribed home-based exercise sessions (walking and strength) completed over the 6-week intervention period, as recorded in participant logbooks and verified during weekly follow-up.
Acceptability
时间窗: 6 weeks
Acceptability of the home-based pulmonary rehabilitation program as assessed by structured caregiver and participant feedback collected at the end of the 6-week intervention.
Adherence rate
时间窗: 6 weeks
Proportion of prescribed home-based exercise sessions (walking and strength) completed over the 6-week intervention period, as recorded in participant logbooks and verified during weekly follow-up.
Acceptability
时间窗: 6 weeks
Acceptability of the home-based pulmonary rehabilitation program as assessed by structured caregiver and participant feedback collected at the end of the 6-week intervention.
次要结局
- Change in St. George's Respiratory Questionnaire (SGRQ) score(6 weeks)
- Change in Six-Minute Walk Distance (6MWT)(6 weeks)
- Change in Body mass index (BMI)(6 weeks)
- Change in Six-Minute Walk Distance (6MWT)(6 weeks)
- Change in St. George's Respiratory Questionnaire (SGRQ) score(6 weeks)
- Change in Body mass index (BMI)(6 weeks)
研究者
Greta L. Becker
Resident Physician
University of Iowa