Mobile health pulmonary rehabilitation (m-PR): a randomised controlled equivalence trial

IF 7.7 1区医学 Q1 RESPIRATORY SYSTEM

Thorax Pub Date : 2025-09-24 DOI:10.1136/thorax-2024-222823

Sarah E Brown, Sally Wootton, Marita T Dale, Jennifer A Alison, Andrew S L Chan, Marlien Varnfield, Ian Yang, Michelle Cunich, Zoe J McKeough

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引用次数: 0

Abstract

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. No data are available. The participants of this study did not give written consent for their data to be shared publicly. Further ethics approval would be required for data release after contacting the corresponding author.

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移动健康肺康复（m-PR）：一项随机对照等效试验

背景：移动医疗（mHealth）是一种新型的医疗模式，可以克服肺部康复（PR）的障碍。本研究确定了在改善慢性阻塞性肺疾病（COPD）患者的运动能力和健康状况方面，移动健康PR是否等同于基于中心的PR （CB-PR）。方法采用意向治疗分析的单盲、多中心、随机对照等效试验。参与者完成了8周的移动健康公关，使用移动公关（m-PR）应用程序并通过电话支持，或CB-PR。在基线和干预结束时测量的共同主要结局是6分钟步行距离（6MWD）和COPD评估测试（CAT）评分的变化，等效幅度分别为30 m和2分。90名参与者被随机分配（平均（SD）， m-PR n = 44）：年龄75(7)岁；1秒用力呼气量（FEV1）预测值为58 (15)%；CB-PR n = 46: 75(6)岁；FEV1为55（预测为14）%)，其中38名m-PR参与者和42名CB-PR参与者完成了至少一个主要结局。干预结束时，6MWD组间无差异（平均差异（MD） 13 m， 95% CI - 6至31），表明m- pr与CB-PR等效。CAT评分组间差异显著（MD为- 4.9分，95% CI为- 7.2至- 2.6），两组CI均超过等效边界，表明m-PR的优越性。结论：与CB-PR相比，移动健康PR计划对COPD患者的运动能力和健康状况的改善效果相当。移动健康公关可以作为一种有效的管理选择，为患有慢性阻塞性肺病的人有足够的数字素养。试验注册号ACTRN12619001253190。无数据。这项研究的参与者没有书面同意他们的数据被公开分享。在与通讯作者联系后，数据发布需要进一步的伦理批准。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Thorax 医学-呼吸系统

CiteScore

16.10

自引率

2.00%

发文量

197

审稿时长

1 months

期刊介绍： Thorax stands as one of the premier respiratory medicine journals globally, featuring clinical and experimental research articles spanning respiratory medicine, pediatrics, immunology, pharmacology, pathology, and surgery. The journal's mission is to publish noteworthy advancements in scientific understanding that are poised to influence clinical practice significantly. This encompasses articles delving into basic and translational mechanisms applicable to clinical material, covering areas such as cell and molecular biology, genetics, epidemiology, and immunology.