Rationale Pulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR). Objective To investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV1 <50% eligible for routine hospital-based, outpatient PR. Methods In this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60 min, three times weekly) or conventional PR (90 min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks’ follow-up from baseline. The primary analysis was based on the intention-to-treat principle. Measurements and main results The primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD age 68±9 years, FEV1 33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95% CI: −6.6 to 24.9)) or at 22 weeks’ follow-up (−5.3 metres (95% CI: −28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (χ2 test p<0.01). Conclusion PTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design. Trial registration number ClinicalTrials.gov (NCT02667171), 28 January 2016.

中文翻译：

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有监督的肺远程康复与重度 COPD 肺康复的比较：一项随机多中心试验

基本原理 肺康复 (PR) 是 COPD 患者的一种有效、关键的标准治疗方法。然而，据报告参加人数低、出席人数不足和辍学率高。有必要对通过替代方法获得的好处进行调查，例如肺远程康复 (PTR)。目的 探讨 PTR 在 6 分钟步行距离（6MWD）上是否优于常规 PR，其次在符合常规住院治疗的 COPD 患者的呼吸道症状、生活质量、体力活动和下肢肌肉功能方面，门诊公关。方法 在这项单盲、多中心、优势随机对照试验中，患者被分配 1:1 至 10 周的基于组的 PTR（60 分钟，每周 3 次）或常规 PR（90 分钟，每周两次）。评估由不知情的评估员在基线、干预结束和从基线开始的 22 周随访时进行。主要分析基于意向治疗原则。测量和主要结果 主要结果是 6MWD 从基线到 10 周的变化；134 名参与者（74 名女性，平均±SD 年龄 68±9 岁，FEV1 预测值 33%±9%，6MWD 327±103 米）被纳入并随机分组。分析显示干预后（9.2 米（95% CI：-6.6 至 24.9））或 22 周随访（-5.3 米（95% CI：-28.9 至 18.3））的 6MWD 变化没有组间差异）。完成 PTR 干预的参与者 (n=57) 比传统 PR (n=43) 多（χ2 检验 p<0.01）。结论 PTR 在 6MWD 上并不优于传统 PR，我们发现组间没有差异。随着更多参与者完成 PTR，在非劣效性设计中，监督 PTR 将与传统 PR 进行比较。试验注册号 ClinicalTrials.gov (NCT02667171)，2016 年 1 月 28 日。