Study Results
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Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-07-29
2026-02-23
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Home-Based Pulmonary Rehabilitation Program
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Residence outside the Kampala metropolitan area
* Active respiratory infection (late exclusion criterion)
6 Years
17 Years
ALL
No
Sponsors
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MU-JHU CARE
OTHER
University of Iowa
OTHER
Responsible Party
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Greta L. Becker
Resident Physician
Principal Investigators
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Greta L Becker, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Eric Wobudeya, MBChB, MMED, MSc
Role: PRINCIPAL_INVESTIGATOR
MU-JHU Care Ltd/MU-JHU Research Collaboration
Locations
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MU-JHU Care Ltd/MU-JHU Research Collaboration
Kampala, , Uganda
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Related Links
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Makerere University-Johns Hopkins University Research Collaboration
University of Iowa Department of Internal Medicine Research Programs
Other Identifiers
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MHREC 2025-282
Identifier Type: OTHER
Identifier Source: secondary_id
HS622ES
Identifier Type: OTHER
Identifier Source: secondary_id
202503518
Identifier Type: -
Identifier Source: org_study_id
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