Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-27 @ 10:09 PM
Study NCT ID:
NCT07097961
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paediatric Post-TB Pulmonary Rehab Study
Sponsor:
University of Iowa
Organization:
Study Overview
Official Title:
Paediatric Post-TB Home-based Pulmonary Rehabilitation Feasibility Study
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPT Rehab
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: