Thorax · 2026
Mobile health pulmonary rehabilitation (m-PR): a randomised controlled equivalence trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Brown Sarah E, Wootton Sally, Dale Marita T, Alison Jennifer A, Chan Andrew S L, Varnfield Marlien, Yang Ian, Cunich Michelle, McKeough Zoe J
Аннотация
BACKGROUND: Mobile health (mHealth) is a novel model of care that may overcome barriers to pulmonary rehabilitation (PR) access. This study determined if mHealth PR was equivalent to centre-based PR (CB-PR) in improving exercise capacity and health status in people with chronic obstructive pulmonary disease (COPD).
METHOD: Single-blinded, multicentre, randomised controlled equivalence trial using an intention-to-treat analysis. Participants completed 8 weeks of either mHealth PR, using the mobile PR (m-PR) application and supported by telephone calls, or CB-PR. Co-primary outcomes, measured at baseline and end-intervention, were change in 6 minute walk distance (6MWD) and COPD assessment test (CAT) score, with an equivalence margin of 30 m and 2 points, respectively.
RESULTS: 90 participants were randomised (mean (SD), m-PR n = 44: age 75 (7) years; forced expiratory volume in one second (FEV1) 58 (15) % predicted; CB-PR n = 46: age 75 (6) years; FEV1 55 (14) % predicted) with 38 m-PR participants and 42 CB-PR participants completing at least one primary outcome. At end-intervention, there was no between-group difference in 6MWD (mean difference (MD) 13 m, 95% CI -6 to 31), indicating equivalence of m-PR to CB-PR. There was a significant between-group difference in CAT score (MD -4.9 points, 95% CI -7.2 to -2.6), with both limits of the CI exceeding the equivalence margin, indicating superiority of m-PR.
CONCLUSION: An mHealth PR programme resulted in equivalent improvements in exercise capacity and superior improvements in health status when compared with CB-PR in people with COPD. mHealth PR could be effective as a management option for people with COPD with adequate digital literacy.
TRIAL REGISTRATION NUMBER: ACTRN12619001253190.
METHOD: Single-blinded, multicentre, randomised controlled equivalence trial using an intention-to-treat analysis. Participants completed 8 weeks of either mHealth PR, using the mobile PR (m-PR) application and supported by telephone calls, or CB-PR. Co-primary outcomes, measured at baseline and end-intervention, were change in 6 minute walk distance (6MWD) and COPD assessment test (CAT) score, with an equivalence margin of 30 m and 2 points, respectively.
RESULTS: 90 participants were randomised (mean (SD), m-PR n = 44: age 75 (7) years; forced expiratory volume in one second (FEV1) 58 (15) % predicted; CB-PR n = 46: age 75 (6) years; FEV1 55 (14) % predicted) with 38 m-PR participants and 42 CB-PR participants completing at least one primary outcome. At end-intervention, there was no between-group difference in 6MWD (mean difference (MD) 13 m, 95% CI -6 to 31), indicating equivalence of m-PR to CB-PR. There was a significant between-group difference in CAT score (MD -4.9 points, 95% CI -7.2 to -2.6), with both limits of the CI exceeding the equivalence margin, indicating superiority of m-PR.
CONCLUSION: An mHealth PR programme resulted in equivalent improvements in exercise capacity and superior improvements in health status when compared with CB-PR in people with COPD. mHealth PR could be effective as a management option for people with COPD with adequate digital literacy.
TRIAL REGISTRATION NUMBER: ACTRN12619001253190.