带电子健康支持的照料者介导的锻炼用于卒后早期支持出院（CARE4STROKE）：一项随机对照试验。
Caregiver-mediated exercises with e-health support for early supported discharge after stroke (CARE4STROKE): A randomized controlled trial.
机构信息
Amsterdam Rehabilitation Research Centre, Reade, Amsterdam, The Netherlands.
Department of Rehabilitation Medicine, Amsterdam Neuroscience and Amsterdam Movement Sciences, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
出版信息
PLoS One. 2019 Apr 8;14(4):e0214241. doi: 10.1371/journal.pone.0214241. eCollection 2019.
BACKGROUND AND PURPOSE
We designed an 8-week caregiver-mediated exercise program with e-health support after stroke (CARE4STROKE) in addition to usual care with the aim to improve functional outcome and to facilitate early supported discharge by increasing the intensity of task specific training.
METHODS
An observer-blinded randomized controlled trial in which 66 stroke patient-caregiver couples were included during inpatient rehabilitation. Patients allocated to the CARE4STROKE program trained an additional amount of 150 minutes a week with a caregiver and were compared to a control group that received usual care alone. Primary outcomes: self-reported mobility domain of the Stroke Impact Scale 3.0 (SIS) and length of stay (LOS). Secondary outcomes: motor impairment, strength, walking ability, balance, mobility and (Extended) Activities of Daily Living of patients, caregiver strain of caregivers, and mood, self-efficacy, fatigue and quality of life of both patients and caregivers. Outcomes were assessed at baseline, 8 and 12 weeks after randomization.
RESULTS
No significant between-group differences were found regarding SIS-mobility after 8 (β 6.21, SD 5.16; P = 0.229) and 12 weeks (β 0.14, SD 2.87; P = 0.961), and LOS (P = 0.818). Significant effects in favor of the intervention group were found for patient's anxiety (β 2.01, SD 0.88; P = 0.023) and caregiver's depression (β 2.33, SD 0.77; P = 0.003) post intervention. Decreased anxiety in patients remained significant at the 12-week follow-up (β 1.01, SD 0.40; P = 0.009).
CONCLUSIONS
This proof-of concept trial did not find significant effects on both primary outcomes mobility and LOS as well as the secondary functional outcomes. Treatment contrast in terms of total exercise time may have been insufficient to achieve these effects. However, caregiver-mediated exercises showed a favorable impact on secondary outcome measures of mood for both patient and caregiver.
CLINICAL TRIAL REGISTRATION
NTR4300, URL- http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4300.
背景与目的
我们设计了一项为期 8 周的、以家庭为中心的、结合电子健康支持的卒中后康复锻炼项目（CARE4STROKE），旨在通过增加任务特定训练的强度，改善功能结局并促进早期康复。
方法
在住院康复期间，我们对 66 对卒中患者-照顾者进行了一项盲法随机对照试验。被分配到 CARE4STROKE 项目的患者每周与照顾者一起额外训练 150 分钟，并与仅接受常规护理的对照组进行比较。主要结局：自我报告的卒中影响量表 3.0（SIS）的移动域和住院时间（LOS）。次要结局：患者的运动障碍、力量、步行能力、平衡、移动能力和（扩展）日常生活活动能力，照顾者的压力，以及患者和照顾者的情绪、自我效能、疲劳和生活质量。在随机分组后 8 周和 12 周进行评估。
结果
在 8 周（β 6.21，SD 5.16；P = 0.229）和 12 周（β 0.14，SD 2.87；P = 0.961）时，SIS 移动和 LOS 两组间均无显著差异，且差异无统计学意义（P = 0.818）。干预组患者焦虑（β 2.01，SD 0.88；P = 0.023）和照顾者抑郁（β 2.33，SD 0.77；P = 0.003）的改善有显著效果。患者的焦虑在 12 周随访时仍有显著改善（β 1.01，SD 0.40；P = 0.009）。
结论
本概念验证试验未发现对移动和 LOS 这两个主要结局以及对二级功能结局有显著影响。从总锻炼时间的治疗对比来看，可能不足以达到这些效果。然而，以家庭为中心的锻炼对患者和照顾者的情绪等次要结局有有利影响。
临床试验注册
NTR4300，网址- http://www.trialregister.nl/trialreg/admin/rctview.asp？TC=4300。
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