Paediatric Post-TB Pulmonary Rehab Study

NCT07097961 | Recruiting

• 3 other identifiers: 202503518MHREC 2025-282HS622ES
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Tuberculosis in Children; Chronic Lung Disease; Post Tuberculosis

Keywords

Post-TB lung disease; Uganda; Pulmonary rehabilitation; pediatric tuberculosis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 weeks

Secondary Outcomes (3)

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

  6 weeks

• Change in Six-Minute Walk Distance (6MWT)

  6 weeks

• Change in Body mass index (BMI)

  6 weeks

Other Outcomes (3)

• Retention

  6 weeks

• Adverse events during intervention period

  6 weeks

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

  6 weeks

Study Arms (1)

Home-Based Pulmonary Rehabilitation Program

EXPERIMENTAL

Behavioral: Pulmonary Rehabilitation

Interventions

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.

Home-Based Pulmonary Rehabilitation Program

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6-17 years
• Previously diagnosed with post-TB lung disease,
• Willing to remain in the study catchment area during the study period

You may not qualify if:

• Currently participating in another rehabilitation program
• Residence outside the Kampala metropolitan area

Sponsors & Collaborators

• University of Iowa: lead
• MU-JHU CARE: collaborator

Study Sites (1)

MU-JHU Care Ltd/MU-JHU Research Collaboration

Kampala, Uganda

RECRUITING

Related Publications (2)

• Migliori GB, Marx FM, Ambrosino N, Zampogna E, Schaaf HS, van der Zalm MM, Allwood B, Byrne AL, Mortimer K, Wallis RS, Fox GJ, Leung CC, Chakaya JM, Seaworth B, Rachow A, Marais BJ, Furin J, Akkerman OW, Al Yaquobi F, Amaral AFS, Borisov S, Caminero JA, Carvalho ACC, Chesov D, Codecasa LR, Teixeira RC, Dalcolmo MP, Datta S, Dinh-Xuan AT, Duarte R, Evans CA, Garcia-Garcia JM, Gunther G, Hoddinott G, Huddart S, Ivanova O, Laniado-Laborin R, Manga S, Manika K, Mariandyshev A, Mello FCQ, Mpagama SG, Munoz-Torrico M, Nahid P, Ong CWM, Palmero DJ, Piubello A, Pontali E, Silva DR, Singla R, Spanevello A, Tiberi S, Udwadia ZF, Vitacca M, Centis R, D Ambrosio L, Sotgiu G, Lange C, Visca D. Clinical standards for the assessment, management and rehabilitation of post-TB lung disease. Int J Tuberc Lung Dis. 2021 Oct 1;25(10):797-813. doi: 10.5588/ijtld.21.0425.

  PMID: 34615577 BACKGROUND

• Becker GL, Kisembo H, Sato Y, Wendt LH, Aanyu-Tukamuhebwa H, Nantanda R, Jackson JB, Blount RJ, Wobudeya E. Post-TB lung function, quality of life, and radiographic findings in children. IJTLD Open. 2025 Jul 9;2(7):427-433. doi: 10.5588/ijtldopen.24.0675. eCollection 2025 Jul.

  PMID: 40657266 BACKGROUND

Related Links

• Makerere University-Johns Hopkins University Research Collaboration
• University of Iowa Department of Internal Medicine Research Programs

Study Officials

• Greta L Becker, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Eric Wobudeya, MBChB, MMED, MSc

  MU-JHU Care Ltd/MU-JHU Research Collaboration

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greta L Becker, MD

CONTACT

15635529422; greta-becker@uiowa.edu

Brooks Jackson, MD, MBA

CONTACT

14109262647; brooks-jackson@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: August 1, 2025
• Study Start: July 29, 2025
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-07

Locations

UG (1)