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基于家庭的、个体化的干预措施降低卒中后跌倒风险(FAST):一项随机试验方案。

Home-based, tailored intervention for reducing falls after stroke (FAST): Protocol for a randomized trial.

机构信息

Faculty of Medicine, Health and Human Sciences, 7788Macquarie University, Sydney, Australia.

Faculty of Medicine and Health, 4334The University of Sydney, Sydney, Australia.

出版信息

Int J Stroke. 2021 Dec;16(9):1053-1058. doi: 10.1177/1747493021991990. Epub 2021 Feb 10.

DOI:10.1177/1747493021991990
PMID:33568018
Abstract

RATIONALE

People with stroke experience falls at more than twice the rate of the general older population resulting in high fall-related injuries. However, there are currently no effective interventions that prevent falls after stroke.

AIMS

To determine the effect and cost-benefit of an innovative, home-based, tailored intervention to reduce falls after stroke.

SAMPLE SIZE ESTIMATE

A total of 370 participants will be recruited in order to be able to detect a clinically important between-group difference of a 30% lower rate of falls with 80% power at a two-tailed significance level of 0.05.

METHODS AND DESIGN

alls fter troke rial (FAST) is a multistate, Phase III randomized trial with concealed allocation, blinded assessment, and intention-to-treat analysis. Ambulatory stroke survivors within five years of stroke who have been discharged from formal rehabilitation to the community and who have no significant language impairment will be randomly allocated to receive habit-forming exercise, home safety, and community mobility training or usual care.

STUDY OUTCOMES

The primary outcome is the rate of falls over the previous 12 months. Secondary outcomes are the risk of falling (proportion of fallers), community participation, self-efficacy, balance, mobility, physical activity, depression, and health-related quality of life. Health care utilization will be collected retrospectively at baseline and prospectively to 6 and 12 months.

DISCUSSION

The results of FAST are anticipated to directly influence intervention for stroke survivors in the community. ANZCTR 12619001114134.

摘要

背景

中风患者跌倒的发生率是普通老年人群的两倍以上,导致跌倒相关伤害的发生率较高。然而,目前尚无有效的干预措施可以预防中风后的跌倒。

目的

确定一种创新的、基于家庭的、个性化的干预措施对减少中风后跌倒的效果和成本效益。

样本量估计

总共将招募 370 名参与者,以便能够以 80%的功效和双侧显著性水平 0.05 检测到组间有 30%的跌倒率差异。

方法和设计

all after stroke trial(FAST)是一项多州、III 期随机试验,采用隐蔽分组、盲法评估和意向治疗分析。在中风后五年内已从正规康复出院到社区且无明显语言障碍的活动能力受限的中风幸存者将被随机分配接受习惯形成运动、家庭安全和社区活动能力训练或常规护理。

研究结果

主要结果是前 12 个月的跌倒率。次要结果是跌倒风险(跌倒者比例)、社区参与度、自我效能感、平衡能力、活动能力、身体活动、抑郁和健康相关生活质量。在基线和 6 个月和 12 个月时将回顾性收集医疗保健利用情况,并前瞻性收集。

讨论

FAST 的结果预计将直接影响社区中风幸存者的干预措施。ANZCTR 12619001114134。

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