Centre for Health and Rehabilitation Technologies, Ulster University, Newtownabbey, UK.
Centre Experimental Medicine, School of Medicine, Dentistry & Biomedical Sciences, Queen's University Belfast, Northern Ireland, UK.
Thorax. 2017 Jul;72(7):594-595. doi: 10.1136/thoraxjnl-2016-208723. Epub 2016 Nov 15.
To investigate the effectiveness of a 6-week exercise programme in patients discharged home following critical illness compared with standard care.
Multicentre prospective phase II randomised controlled trial, with blinded outcome assessment after hospital discharge, following the 6-week intervention and at 6 months.
60 patients (30 per group) aged ≥18 years, mechanically ventilated >96 hours, and not in other rehabilitation, that is, cardiac or pulmonary rehabilitation programmes. Participants in the intervention group completed an individually tailored (personalised) exercise programme.
Primary outcome measure was SF-36 physical functioning following the intervention. Secondary outcomes included a range of performance-based and patient-reported measures.
Improvements in the primary outcome did not differ significantly between groups (mean difference (95% CI) 3.0 (-2.2 to 8.2), p=0.26). The intervention group showed significant improvement compared with the control group (mean difference (95% CI)) in SF-36 role physical (6.6 (0.73 to 12.5), p=0.03); incremental shuttle walk test (83.1 m (8.3 to 157.9), p=0.03); functional limitations profile (-4.8 (-8.7 to -0.9), p=0.02); self-efficacy to exercise (2.2 (0.8 to 3.7), p=0.01) and readiness to exercise (1.3 (0.8 to 1.9), p<0.001). These improvements were not sustained at 6 months except readiness to exercise. Improvements in all other secondary outcome measures were not significant.
There was no statistically significant difference in the primary outcome measure of self-reported physical function following this 6-week exercise programme. Secondary outcome results will help inform future studies.
NCT01463579. (results), https://clinicaltrials.gov/.
比较 6 周运动方案与标准护理在重症疾病出院患者中的疗效。
多中心前瞻性 II 期随机对照试验，在出院后、6 周干预后和 6 个月进行盲法结局评估。
年龄≥18 岁、机械通气>96 小时且未接受其他康复治疗（即心脏或肺康复治疗）的 60 名患者（每组 30 名）。干预组患者完成了个体化的运动方案。
主要结局测量是干预后 SF-36 身体功能。次要结局指标包括一系列基于表现和患者报告的测量。
两组间主要结局的改善无显著差异（平均差异（95%CI）为 3.0（-2.2 至 8.2），p=0.26）。与对照组相比，干预组在 SF-36 角色身体功能（6.6（0.73 至 12.5），p=0.03）；递增穿梭步行测试（83.1 m（8.3 至 157.9），p=0.03）；功能限制谱（-4.8（-8.7 至 -0.9），p=0.02）；运动自我效能感（2.2（0.8 至 3.7），p=0.01）和运动准备（1.3（0.8 至 1.9），p<0.001）方面均有显著改善。这些改善在 6 个月时并未持续，只有运动准备方面仍保持。其他次要结局指标的改善均无统计学意义。
在 6 周运动方案后，自我报告的身体功能主要结局测量无统计学显著差异。次要结局结果将有助于指导未来的研究。
NCT01463579（结果），https://clinicaltrials.gov/。
