Discipline of Physiotherapy, School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, QLD, Australia.
School of Physiotherapy, Faculty of Health Sciences, Australian Catholic University, Banyo, QLD, Australia.
BMC Neurol. 2018 Jan 30;18(1):13. doi: 10.1186/s12883-018-1015-6.
The level of physical activity undertaken by stroke survivors living in the community is generally low. The main objectives of the IMPACT trial are to determine, in individuals undergoing rehabilitation after stroke, if 8 weeks of high-intensity treadmill training embedded in self-management education (i) results in more physical activity than usual physiotherapy gait training and (ii) is more effective at increasing walking ability, cardiorespiratory fitness, self-efficacy, perception of physical activity, participation, and health-related quality of life as well as decreasing cardiovascular risk, and depression, at 8 and 26 weeks.
A prospective, two-arm, parallel-group, randomised trial with concealed allocation, blinded measurement and intention-to-treat analysis, will be conducted. 128 stroke survivors undergoing rehabilitation who are able to walk independently will be recruited and randomly allocated to either the experimental or control group, who will both undergo gait training for 30 min, three times a week for 8 weeks under the supervision of a physiotherapist. Outcomes will be measured at baseline (Week 0), on completion of the intervention (Week 8) and beyond the intervention (Week 26). This study has obtained ethical approval from the relevant Human Research Ethics Committees.
Improving stroke survivors' walking ability and cardiorespiratory fitness is likely to increase their levels of physical activity. Furthermore, if education in self-management results in sustained high levels of physical activity, this should result in improved participation and quality of life.
This trial was registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12613000744752 ) on 4th July, 2013.
社区中脑卒中幸存者的身体活动水平普遍较低。IMPACT 试验的主要目的是确定在经历脑卒中康复的个体中，8 周的高强度跑步机训练嵌入自我管理教育是否（i）比常规物理治疗步态训练产生更多的身体活动，以及（ii）是否更有效地提高步行能力、心肺适能、自我效能感、身体活动感知、参与度以及健康相关生活质量，同时降低心血管风险和抑郁，在 8 周和 26 周时。
这是一项前瞻性、两臂、平行组、随机试验，采用隐蔽分组、盲法测量和意向治疗分析。将招募 128 名正在接受康复治疗且能够独立行走的脑卒中幸存者，并随机分配到实验组或对照组，两组都将在物理治疗师的监督下进行 30 分钟、每周 3 次的步态训练，共 8 周。在基线（第 0 周）、干预结束时（第 8 周）和干预结束后（第 26 周）进行评估。本研究已获得相关人类研究伦理委员会的伦理批准。
提高脑卒中幸存者的步行能力和心肺适能可能会增加他们的身体活动水平。此外，如果自我管理教育导致持续高水平的身体活动，这应该会导致参与度和生活质量的提高。
该试验于 2013 年 7 月 4 日在澳大利亚和新西兰临床试验注册中心（ACTRN12613000744752）注册。
