Paediatric Post-TB Pulmonary Rehab Study

ConditionsTuberculosis in Children Chronic Lung Disease Post Tuberculosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-17

SponsorUniversity of Iowa

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Currently participating in another rehabilitation program

Residence outside the Kampala metropolitan area

Active respiratory infection (late exclusion criterion)

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Home-Based Pulmonary Rehabilitation ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Iowa

Lead sponsor

MU-JHU CARE

Collaborator

Source ClinicalTrials.gov

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