Paediatric Post-TB Pulmonary Rehab Study

Официальное название

Paediatric Post-TB Home-based Pulmonary Rehabilitation Feasibility Study

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Pulmonary Rehabilitation
  The intervention includes twice-weekly walking and wall sit exercises, guided by a physiotherapy assessment. Participants use a pedometer, receive written instructions, and are monitored weekly by phone or home visit. Caregivers supervise the exercises and sessions are logged in a participant workbook.

Первичные конечные точки

• Adherence rate [Срок оценки: 6 weeks]
• Acceptability [Срок оценки: 6 weeks]

Вторичные конечные точки (3)

• Change in St. George's Respiratory Questionnaire (SGRQ) score [Срок оценки: 6 weeks]
• Change in Six-Minute Walk Distance (6MWT) [Срок оценки: 6 weeks]
• Change in Body mass index (BMI) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Currently participating in another rehabilitation program
• Residence outside the Kampala metropolitan area
• Active respiratory infection (late exclusion criterion)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Uganda · 1 центр

• MU-JHU Care Ltd/MU-JHU Research Collaboration — Kampala

Публикации

• Migliori GB, Marx FM, Ambrosino N, Zampogna E, Schaaf HS, van der Zalm MM, Allwood B, Byrne AL, Mortimer K, Wallis RS, Fox GJ, Leung CC, Chakaya JM, Seaworth B, Rachow A, Marais BJ, Furin J, Akkerman OW, Al Yaquobi F, Amaral AFS, Borisov S, Caminero JA, Carvalho ACC, Chesov D, Codecasa LR, Teixeira RC, Dalcolmo MP, Datta S, Dinh-Xuan AT, Duarte R, Evans CA, Garcia-Garcia JM, Gunther G, Hoddinott G PMID 34615577
• Becker GL, Kisembo H, Sato Y, Wendt LH, Aanyu-Tukamuhebwa H, Nantanda R, Jackson JB, Blount RJ, Wobudeya E. Post-TB lung function, quality of life, and radiographic findings in children. IJTLD Open. 2025 Jul 9;2(7):427-433. doi: 10.5588/ijtldopen.24.0675. eCollection 2025 Jul. PMID 40657266

Идентификаторы

NCT: NCT07097961 · 202503518 · MHREC 2025-282 · HS622ES

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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