Telerehabilitation program for COVID-19 survivors (TERECO) - Randomized controlled trial

Objectives To investigate superiority of a telerehabilitation program for Covid-19 (TERECO) over no rehabilitation with regard to exercise capacity, lower-limb muscle strength (LMS), pulmonary function, health-related quality of life (HRQOL), and dyspnoea. Design Parallel-group randomised controlled-trial with 1:1 block-randomisation. Setting Three major hospitals from Jiangsu and Hubei provinces, China. Participants 120 formerly hospitalised Covid-19 survivors with remaining dyspnoea complaints were randomised with 61 allocated to control and 59 to TERECO. Intervention Unsupervised home-based 6-week exercise program comprising breathing control and thoracic expansion, aerobic exercise, and LMS exercise, delivered via smartphone, and remotely monitored with heart rate telemetry. Outcomes Primary outcome was 6-minute walking distance (6MWD) in metres. Secondary outcomes were squat time in seconds; pulmonary function assessed by spirometry; HRQOL measured with SF-12; and mMRC-dyspnoea. Outcomes were assessed at 6 weeks (post-treatment) and 28 weeks (follow-up). Results Adjusted between-group difference in change in 6MWD was 65.45 metres (95% CI 43.8, 87.1; p<0.001) at post-treatment and 68.62 metres (95% CI 46.39, 90.85; p<0.001) at follow-up. Treatment effects for LMS were 20.12 seconds (95% CI 12.34, 27.9; p<0.001) post-treatment and 22.23 seconds (95% CI 14.24, 30.21; p<0.001) at follow-up. No group differences were found for lung function except post-treatment MVV. Increase in SF-12 physical component was greater in the TERECO group with treatment effects estimated as 3.79 (95% CI 1.24, 6.35; p=0.004) at post-treatment and 2.69 (95% CI 0.06, 5.32; p=0.045) at follow-up. Conclusions This trial demonstrated superiority of TERECO over no rehabilitation for 6MWD, LMS, and physical HRQOL. Trial registration: ChiCTR2000031834, URL: http://www.chictr.org.cn/showproj.aspx?proj=52216研究目的：探讨针对新型冠状病毒肺炎（COVID-19）的远程康复项目（TERECO）相较于无康复干预，在运动能力、下肢肌肉力量（lower-limb muscle strength, LMS）、肺功能、健康相关生活质量（health-related quality of life, HRQOL）以及呼吸困难方面的优势。 研究设计：采用1:1区组随机化的平行组随机对照试验。 研究机构：中国江苏省与湖北省的3家三甲医院。 研究对象：120名曾住院治疗且仍存在呼吸困难症状的新冠康复者，按随机分配原则分为对照组（61例）与TERECO组（59例）。 干预措施：通过智能手机实施的非监督式居家6周运动康复方案，涵盖呼吸控制与胸廓扩张训练、有氧运动及下肢肌肉力量训练，并通过心率遥测技术进行远程监测。 结局指标：主要结局指标为6分钟步行距离（6-minute walking distance, 6MWD），单位为米。次要结局指标包括蹲起时长（单位为秒）、肺功能（采用肺量计检测）、采用SF-12量表评估的健康相关生活质量，以及mMRC呼吸困难评分。分别于干预6周后（治疗结束时）与随访28周时评估上述结局指标。 研究结果：治疗结束时，两组6MWD变化值的校正组间差异为65.45米（95%置信区间CI：43.8, 87.1；p<0.001）；随访时该差异为68.62米（95%CI：46.39, 90.85；p<0.001）。下肢肌肉力量的治疗效应在治疗结束时为20.12秒（95%CI：12.34, 27.9；p<0.001），随访时为22.23秒（95%CI：14.24, 30.21；p<0.001）。肺功能方面，除治疗结束时的最大自主通气量（MVV）外，其余指标均未观察到组间差异。SF-12躯体成分评分的提升在TERECO组更为显著，治疗效应在治疗结束时为3.79（95%CI：1.24, 6.35；p=0.004），随访时为2.69（95%CI：0.06, 5.32；p=0.045）。 研究结论：本试验证实，TERECO相较于无康复干预，在6MWD、下肢肌肉力量及躯体健康相关生活质量方面均展现出显著优势。 试验注册编号：ChiCTR2000031834，注册网址：http://www.chictr.org.cn/showproj.aspx?proj=52216