Study protocol for a randomised controlled trial assessing the impact of pulmonary rehabilitation on maximal exercise capacity for adults living with post-TB lung disease: Global RECHARGE Uganda
Introduction The burden of post-tuberculosis (TB) lung disease (PTBLD) is steadily increasing in sub-Saharan Africa, causing disability among TB survivors. Without effective medicines, the mainstay of PTBLD treatment evolves around disease prevention and supportive treatment. Pulmonary rehabilitatio...
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BMJ Publishing Group
2021-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/8/e047641.full |
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| author | Andy Barton Winceslaus Katagira Rupert Jones Adrian Manise Mark W. Orme Amy V. Jones Richard Kasiita Ruhme B. Miah Jesse A. Matheson Robert C. Free Michael C. Steiner Bruce J. Kirenga Sally J. Singh |
| author_facet | Andy Barton Winceslaus Katagira Rupert Jones Adrian Manise Mark W. Orme Amy V. Jones Richard Kasiita Ruhme B. Miah Jesse A. Matheson Robert C. Free Michael C. Steiner Bruce J. Kirenga Sally J. Singh |
| author_sort | Andy Barton |
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| description | Introduction The burden of post-tuberculosis (TB) lung disease (PTBLD) is steadily increasing in sub-Saharan Africa, causing disability among TB survivors. Without effective medicines, the mainstay of PTBLD treatment evolves around disease prevention and supportive treatment. Pulmonary rehabilitation (PR), a low-cost, non-pharmacological intervention has shown effectiveness in a group of PTBLD individuals but has not been tested in a clinical trial. This study aims to assess the impact of a 6-week PR programme on maximal exercise capacity and other outcomes among adults in Uganda living with PTBLD.Methods and analysis This is a randomised waiting-list controlled trial with blinded outcome measures, comparing PR versus usual care for patients with PTBLD. A total of 114 participants will be randomised (1:1) to receive either usual care (on the waiting list) or PR, with follow-up assessments at 6 weeks and 12 weeks postintervention. The primary outcome is change in walking distance measured by the Incremental Shuttle Walk Test from baseline to the end of 6 weeks of PR. All secondary outcomes will be compared between the PR and usual care arms from baseline to 6-week and 12-week follow-ups. Secondary outcomes include self-reported respiratory symptoms, physical activity, psychological well-being, health-related quality of life and cost–benefit analysis. All randomised participants will be included in the intention-to-treat analysis population. The primary efficacy analysis will be based on both per-protocol and modified intention-to-treat populations.Ethics and dissemination The trial has received ethical clearance from the Mulago Hospital Research and Ethics Committee (MHREC 1478), Kampala, Uganda as well as the Uganda National Council for Science and Technology (SS 5105). Ethical approval has been obtained from the University of Leicester, UK research ethics committee (Ref No. 22349). Study findings will be published in appropriate peer-reviewed journals and disseminated at appropriate local, regional and international scientific meetings and conferences.Trial registration number ISRCTN18256843.Protocol version Version 1.0 July 2019. |
| format | Article |
| id | doaj-art-eca658698cd24edcb12b8790de38f4e5 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-08-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-eca658698cd24edcb12b8790de38f4e52025-08-20T02:20:38ZengBMJ Publishing GroupBMJ Open2044-60552021-08-0111810.1136/bmjopen-2020-047641Study protocol for a randomised controlled trial assessing the impact of pulmonary rehabilitation on maximal exercise capacity for adults living with post-TB lung disease: Global RECHARGE UgandaAndy Barton0Winceslaus Katagira1Rupert Jones2Adrian Manise3Mark W. Orme4Amy V. Jones5Richard Kasiita6Ruhme B. Miah7Jesse A. Matheson8Robert C. Free9Michael C. Steiner10Bruce J. Kirenga11Sally J. Singh12NIHR Research Design Service - South WestLung Institute, Makerere University College of Health Sciences, Kampala, Uganda8 Faculty of Health, University of Plymouth, Plymouth, UKNIHR Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust, Leicester, Leicestershire, UKDepartment of Respiratory Sciences, University of Leicester, Leicester, UKDepartment of Respiratory Sciences, University of Leicester, Leicester, UKDepartment of Physiotherapy, Mulago National Referral Hospital, Kampala, UgandaDepartment of Respiratory Sciences, University of Leicester, Leicester, UKDepartment of Economics, University of Sheffield, Sheffield, UKCentre for Exercise and Rehabilitation Science (CERS), NIHR Leicester Biomedical Research Centre – Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UKDepartment of Respiratory Sciences, University of Leicester, Leicester, UKMakerere University Lung Institute, Kampala, UgandaDepartment of Respiratory Sciences, University of Leicester, Leicester, UKIntroduction The burden of post-tuberculosis (TB) lung disease (PTBLD) is steadily increasing in sub-Saharan Africa, causing disability among TB survivors. Without effective medicines, the mainstay of PTBLD treatment evolves around disease prevention and supportive treatment. Pulmonary rehabilitation (PR), a low-cost, non-pharmacological intervention has shown effectiveness in a group of PTBLD individuals but has not been tested in a clinical trial. This study aims to assess the impact of a 6-week PR programme on maximal exercise capacity and other outcomes among adults in Uganda living with PTBLD.Methods and analysis This is a randomised waiting-list controlled trial with blinded outcome measures, comparing PR versus usual care for patients with PTBLD. A total of 114 participants will be randomised (1:1) to receive either usual care (on the waiting list) or PR, with follow-up assessments at 6 weeks and 12 weeks postintervention. The primary outcome is change in walking distance measured by the Incremental Shuttle Walk Test from baseline to the end of 6 weeks of PR. All secondary outcomes will be compared between the PR and usual care arms from baseline to 6-week and 12-week follow-ups. Secondary outcomes include self-reported respiratory symptoms, physical activity, psychological well-being, health-related quality of life and cost–benefit analysis. All randomised participants will be included in the intention-to-treat analysis population. The primary efficacy analysis will be based on both per-protocol and modified intention-to-treat populations.Ethics and dissemination The trial has received ethical clearance from the Mulago Hospital Research and Ethics Committee (MHREC 1478), Kampala, Uganda as well as the Uganda National Council for Science and Technology (SS 5105). Ethical approval has been obtained from the University of Leicester, UK research ethics committee (Ref No. 22349). Study findings will be published in appropriate peer-reviewed journals and disseminated at appropriate local, regional and international scientific meetings and conferences.Trial registration number ISRCTN18256843.Protocol version Version 1.0 July 2019.https://bmjopen.bmj.com/content/11/8/e047641.full |
| spellingShingle | Andy Barton Winceslaus Katagira Rupert Jones Adrian Manise Mark W. Orme Amy V. Jones Richard Kasiita Ruhme B. Miah Jesse A. Matheson Robert C. Free Michael C. Steiner Bruce J. Kirenga Sally J. Singh Study protocol for a randomised controlled trial assessing the impact of pulmonary rehabilitation on maximal exercise capacity for adults living with post-TB lung disease: Global RECHARGE Uganda BMJ Open |
| title | Study protocol for a randomised controlled trial assessing the impact of pulmonary rehabilitation on maximal exercise capacity for adults living with post-TB lung disease: Global RECHARGE Uganda |
| title_full | Study protocol for a randomised controlled trial assessing the impact of pulmonary rehabilitation on maximal exercise capacity for adults living with post-TB lung disease: Global RECHARGE Uganda |
| title_fullStr | Study protocol for a randomised controlled trial assessing the impact of pulmonary rehabilitation on maximal exercise capacity for adults living with post-TB lung disease: Global RECHARGE Uganda |
| title_full_unstemmed | Study protocol for a randomised controlled trial assessing the impact of pulmonary rehabilitation on maximal exercise capacity for adults living with post-TB lung disease: Global RECHARGE Uganda |
| title_short | Study protocol for a randomised controlled trial assessing the impact of pulmonary rehabilitation on maximal exercise capacity for adults living with post-TB lung disease: Global RECHARGE Uganda |
| title_sort | study protocol for a randomised controlled trial assessing the impact of pulmonary rehabilitation on maximal exercise capacity for adults living with post tb lung disease global recharge uganda |
| url | https://bmjopen.bmj.com/content/11/8/e047641.full |
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