Paediatric Post-TB Pulmonary Rehab Study

Not Applicable

Recruiting

• Conditions: Tuberculosis in Children; Chronic Lung Disease; Post Tuberculosis

• Registration Number: NCT07097961
• Lead Sponsor: University of Iowa

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study Start: 2025-07-29
• Study First Submitted QC: 2025-07-30
• Study First Posted: 2025-08-01
• Last Update Submitted: 2025-08-06
• Last Update Posted: 2025-08-11
• Primary Completion: 2026-02-23
• Study Completion: 2026-02-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adherence rate	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Six-Minute Walk Distance (6MWT)	6 weeks	The absolute difference in meters walked during the standardized 6MWT from baseline (enrollment visit) to the 6-week follow-up following pulmonary rehabilitation. The 6MWT is a validated test used to measure exercise capacity.
Change in St. George's Respiratory Questionnaire (SGRQ) score	6 weeks	The absolute difference in SGRQ total score and sub-scores from baseline (enrollment visit) to the 6-week follow-up following pulmonary rehabilitation. The SGRQ is a validated tool used to assess health-specific quality of life.
Change in Body mass index (BMI)	6 weeks	The difference in BMI-for-age Z-score, a standardized measure of body mass index adjusted for age and sex, from baseline to the 6-week follow-up. BMI is calculated as weight in kilograms divided by height in meters squared (kg/m²). Z-scores are computed using WHO child growth standards.

Trial Locations

Locations (1)

MU-JHU Care Ltd/MU-JHU Research Collaboration; 🇺🇬 Kampala, Uganda