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NCT Number: NCT07097961

Paediatric Post-TB Pulmonary Rehab Study

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

Recruiting

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MU-JHU Care Ltd/MU-JHU Research Collaboration

Kampala, Uganda

Location status: Recruiting

Location contact

Eric Wobudeya, MBChB, MMed, MSc

CONTACT

[email protected]

+ 256 708162351

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pulmonary rehabilitation

Behavioral

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.

Primary outcomes

  1. Adherence rate

    Time frame: 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.

  2. Acceptability

    Time frame: 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 outcomes

  1. Change in St. George's Respiratory Questionnaire (SGRQ) score

    Time frame: 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.

  2. Change in Six-Minute Walk Distance (6MWT)

    Time frame: 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.

  3. Change in Body mass index (BMI)

    Time frame: 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.

Other outcomes

  1. Retention

    Time frame: 6 weeks

    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.

  2. Adverse events during intervention period

    Time frame: 6 weeks

    Number and type of adverse events (e.g., injury, worsening respiratory symptoms) reported during the 6-week rehabilitation program.

  3. Change in walking session distance/steps across the 6-week intervention

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brooks Jackson, MD, MBA

CONTACT

[email protected]

14109262647

Greta L Becker, MD

CONTACT

[email protected]

15635529422

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • MU-JHU CARE

Registry information

Official study title

Paediatric Post-TB Home-based Pulmonary Rehabilitation Feasibility Study

Acronym: PPT Rehab

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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