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

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).

本研究确定了 mHealth PR 是否与中心基础 PR (CB-PR) 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等效。

method

Single-blinded, multicentre, randomised controlled equivalence trial using an intention-to-treatanalysis.

单盲、多中心、随机对照等效试验，采用意向治疗分析。

Participants completed 8 weeks of either mHealth PR, using the mobile PR (m-PR) application and supported by telephone calls, or CB-PR.

参与者完成了8周的移动健康肺康复（mHealth PR），使用移动肺康复（m-PR）应用程序，并通过电话支持，或传统肺康复（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.

主要终点指标在基线和干预结束时测量，包括6分钟步行距离（6MWD）和慢性阻塞性肺疾病评估测试（CAT）评分的变化，等效边界分别为30米和2分。

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.

共有90名参与者被随机分配（平均值（标准差）），m-PR组n=44：年龄75（7）岁；第一秒用力呼气容积（FEV1）58（15）%预测值；CB-PR组n=46：年龄75（6）岁；FEV1 55（14）%预测值），其中38名m-PR参与者和42名CB-PR参与者至少完成了一个主要终点指标。

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.

干预结束时，两组间6分钟步行距离（6MWD）无差异（平均差异（MD）13米，95%置信区间-6至31），表明移动式肺康复（m-PR）与传统肺康复（CB-PR）等效。

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.

两组间CAT评分存在显著差异（平均差异（MD）-4.9分，95%置信区间-7.2至-2.6），置信区间的上下限均超过了等效边界，表明移动式肺康复（m-PR）更优。

Conclusions

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.

一项移动健康肺康复(mHealth PR)计划在改善COPD患者的运动能力方面取得了与传统肺康复(CB-PR)相当的效果，并在改善健康状况方面表现更佳。对于具备足够数字素养的COPD患者，mHealth PR可能是一种有效的管理选择。

trial_registration_number

ACTRN12619001253190.

ACTRN12619001253190。