An interventional study of Pulmonary Rehabilitation in Tuberculosis in Children, Chronic Lung Disease and Post Tuberculosis, sponsored by University of Iowa. Recruiting at 1 site in Uganda. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by University of Iowa · Not applicable, Interventional, and Other
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
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.
University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: 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.
Adherence rate
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.
Time frame: 6 weeks
Acceptability
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.
Time frame: 6 weeks
Change in St. George's Respiratory Questionnaire (SGRQ) score
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.
Time frame: 6 weeks
Change in Six-Minute Walk Distance (6MWT)
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.
Time frame: 6 weeks
Change in Body mass index (BMI)
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.
Time frame: 6 weeks
Retention
The proportion of enrolled participants who complete the 6-week intervention and attend the follow-up visit. This measure provides information on the feasibility of participant follow-up.
Time frame: 6 weeks
Adverse events during intervention period
Number and type of adverse events (e.g., injury, worsening respiratory symptoms) reported during the 6-week rehabilitation program.
Time frame: 6 weeks
Change in walking session distance/steps across the 6-week intervention
Change in the distance walked during prescribed home-based walking sessions from the beginning to the end of the 6-week rehabilitation program, as recorded in participant logbooks. This outcome will explore trends in functional improvement during the intervention period.
Time frame: 6 weeks
Plan to share: Undecided — The data sharing plan has not been finalized. The study team will consider sharing de-identified participant data upon request.
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