Rationale Pulmonary rehabilitation is an effective treatment for people with chronic respiratory disease but is delivered to <5% of eligible individuals. This study investigated whether home-based telerehabilitation was equivalent to centre-based pulmonary rehabilitation in people with chronic respiratory disease. Methods A multicentre randomised controlled trial with assessor blinding, powered for equivalence was undertaken. Individuals with a chronic respiratory disease referred to pulmonary rehabilitation at four participating sites (one rural) were eligible and randomised using concealed allocation to pulmonary rehabilitation or telerehabilitation. Both programmes were two times per week for 8 weeks. The primary outcome was change in Chronic Respiratory Disease Questionnaire Dyspnoea (CRQ-D) domain at end-rehabilitation, with a prespecified equivalence margin of 2.5 points. Follow-up was at 12 months. Secondary outcomes included exercise capacity, health-related quality of life, symptoms, self-efficacy and psychological well-being. Results 142 participants were randomised to pulmonary rehabilitation or telerehabilitation with 96% and 97% included in the intention-to-treat analysis, respectively. There were no significant differences between groups for any outcome at either time point. Both groups achieved meaningful improvement in dyspnoea and exercise capacity at end-rehabilitation. However, we were unable to confirm equivalence of telerehabilitation for the primary outcome ΔCRQ-D at end-rehabilitation (mean difference (MD) (95% CI) −1 point (−3 to 1)), and inferiority of telerehabilitation could not be excluded at either time point (12-month follow-up: MD −1 point (95% CI −4 to 1)). At end-rehabilitation, telerehabilitation demonstrated equivalence for 6-minute walk distance (MD −6 m, 95% CI −26 to 15) with possibly superiority of telerehabilitation at 12 months (MD 14 m, 95% CI −10 to 38). Conclusion telerehabilitation may not be equivalent to centre-based pulmonary rehabilitation for all outcomes, but is safe and achieves clinically meaningful benefits. When centre-based pulmonary rehabilitation is not available, telerehabilitation may provide an alternative programme model. Trial registration number ACtelerehabilitationN12616000360415. Data are available upon reasonable request. Will individual participant data be available (including data dictionaries)? Yes. What data in particular will be shared? Individual participant data can be shared after de-identification and once approval has been obtained from the relevant Human Research Ethics Committee. What other documents will be available? Study protocol. When will data be available (start and end dates)? Data will be available indefinitely on a case by case basis, at the discretion of the coordinating principal investigator and relevant Human Research Ethics Committee. With whom? Data will be available on a case by case basis, at the discretion of the coordinating principal investigator and relevant Human Research Ethics Committee. For what types of analyses? Type of analysis data available for will be at the discretion of the relevant Human Research Ethics Committee. By what mechanism will data be made available? Data requests should, in the first instance, be addressed to Professor Anne Holland (anne.holland@monash.edu). Access to data will be subject to approval by the coordinating principal investigator and relevant Human Research Ethics Committee.

中文翻译：

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慢性呼吸系统疾病的远程康复：一项随机对照等效试验

基本原理 肺康复对于慢性呼吸道疾病患者是一种有效的治疗方法，但适用于<5% 的合格个体。本研究调查了以家庭为基础的远程康复是否等同于慢性呼吸道疾病患者的以中心为基础的肺康复。方法 进行了一项多中心随机对照试验，采用评估者盲法，具有等效性。在四个参与地点（一个农村）接受肺康复治疗的慢性呼吸系统疾病患者符合条件，并使用隐蔽分配方式随机分配至肺康复或远程康复。这两个项目每周两次，持续 8 周。主要结果是终末康复时慢性呼吸系统疾病问卷呼吸困难 (CRQ-D) 域的变化，预先指定的等值边际为 2.5 分。随访时间为 12 个月。次要结果包括运动能力、与健康相关的生活质量、症状、自我效能和心理健康。结果 142 名参与者被随机分配接受肺康复或远程康复治疗，意向治疗分析中分别有 96% 和 97% 的参与者。在任一时间点，各组之间的任何结果均无显着差异。两组在最终康复时的呼吸困难和运动能力都取得了有意义的改善。然而，我们无法确认远程康复与最终康复时的主要结果 ΔCRQ-D 的等效性（平均差 (MD) (95% CI) -1 点（-3 至 1）），并且远程康复的劣势不能在任一时间点排除（12 个月随访：MD -1 点（95% CI -4 至 1））。在结束康复时，远程康复证明了 6 分钟步行距离（MD -6 m，95% CI -26 至 15）的等效性，而远程康复在 12 个月时可能具有优势（MD 14 m，95% CI -10 至 38）。结论 远程康复可能不等同于所有结果的基于中心的肺康复，但它是安全的，并且具有临床意义的益处。当无法提供以中心为基础的肺康复时，远程康复可以提供另一种计划模式。试用注册号 ACtelerehabilitationN12616000360415。可根据合理要求提供数据。个人参与者数据是否可用（包括数据字典）？是的。具体将共享哪些数据？个人参与者数据可以在去识别化后共享，并在获得相关人类研究伦理委员会的批准后共享。还会提供哪些其他文件？研究协议。数据何时可用（开始和结束日期）？数据将根据具体情况无限期提供，由协调的首席研究员和相关的人类研究伦理委员会酌情决定。和谁一起？数据将根据具体情况提供，由协调的首席研究员和相关的人类研究伦理委员会酌情决定。适用于哪些类型的分析？可用的分析数据类型将由相关的人类研究伦理委员会自行决定。通过什么机制提供数据？数据请求应该，首先，请联系 Anne Holland 教授 (anne.holland@monash.edu)。对数据的访问需要得到协调的首席研究员和相关的人类研究伦理委员会的批准。