Respiratory Research@Alfred, Department of Immunology and Pathology, Monash University, Melbourne, Victoria, Australia
Institute for Breathing and Sleep, Melbourne, Victoria, Australia.
Thorax. 2022 Jul;77(7):643-651. doi: 10.1136/thoraxjnl-2021-216934. Epub 2021 Oct 14.
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.
背景：肺康复是治疗慢性呼吸系统疾病患者的有效方法，但只有不到 5%的符合条件的患者接受了肺康复治疗。本研究旨在探讨家庭为基础的远程康复与以中心为基础的肺康复对慢性呼吸系统疾病患者的疗效是否相当。
方法：这是一项多中心、随机对照试验，评估者设盲，为等效性试验设计。来自四个参与研究的中心（一个为农村地区）的慢性呼吸系统疾病患者被纳入研究，并使用隐藏式随机分配方法随机分配到肺康复组或远程康复组。两组患者每周接受两次肺康复治疗，共 8 周。主要结局是康复结束时慢性呼吸系统疾病问卷呼吸困难（CRQ-D）评分的变化，预先设定的等效边际为 2.5 分。随访时间为 12 个月。次要结局包括运动能力、健康相关生活质量、症状、自我效能和心理幸福感。
结果：共有 142 名患者被随机分配到肺康复组或远程康复组，意向治疗分析中分别有 96%和 97%的患者纳入分析。两组患者在任何时间点的任何结局均无显著差异。两组患者在康复结束时呼吸困难和运动能力均有明显改善。然而，我们无法确认远程康复对主要结局（CRQ-D 评分变化）等效，即在康复结束时差异为 1 分（95%CI：-3 至 1），且无法排除远程康复在任何时间点都不如肺康复的可能性（12 个月随访时差异为 1 分，95%CI：-4 至 1）。在康复结束时，远程康复在 6 分钟步行距离上等效（MD：-6m，95%CI：-26 至 15），而在 12 个月时可能优于肺康复（MD：14m，95%CI：-10 至 38）。
结论：远程康复可能并不适用于所有患者，与中心为基础的肺康复等效，但安全且可实现有临床意义的获益。当中心为基础的肺康复不可用时，远程康复可能是一种替代方案。
试验注册号：ACtelerehabilitationN12616000360415。
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