Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, 23100, Stockholm, Sweden.
Women's Health and Allied Health Professionals Theme, Medical Unit Occupational Therapy and Physiotherapy, Karolinska University Hospital, Stockholm, Sweden.
BMC Neurol. 2023 Mar 28;23(1):124. doi: 10.1186/s12883-023-03163-0.
Physical activity is essential to improve health and reduce the risk of recurrence of stroke or transient ischemic attack (TIA). Still, people post stroke or TIA are often physically inactive and the availability of physical activity promotion services are often limited. This study builds on an existing Australian telehealth-delivered programme (i-REBOUND- Let's get moving) which provides support for home-based physical activity for people post stroke or TIA. The aim of this study is to test the feasibility, acceptability, and preliminary effects of a mobile Health (mHealth) version of the i-REBOUND programme for the promotion of physical activity in people post stroke or TIA living in Sweden.
One hundred and twenty participants with stroke or TIA will be recruited via advertisement. A parallel-group feasibility randomised controlled trial design with a 1:1 allocation ratio to 1) i-REBOUND programme receiving physical exercise and support for sustained engagement in physical activity through behavioural change techniques, or 2) behavioural change techniques for physical activity. Both interventions will proceed for six months and be delivered digitally through a mobile app. The feasibility outcomes (i.e., reach, adherence, safety and fidelity) will be monitored throughout the study. Acceptability will be assessed using the Telehealth Usability Questionnaire and further explored through qualitative interviews with a subset of both study participants and the physiotherapists delivering the intervention. Clinical outcomes on preliminary effects of the intervention will include blood pressure, engagement in physical activity, self-perceived exercise self-efficacy, fatigue, depression, anxiety, stress and health-related quality of life and will be measured at baseline and at 3, 6 and 12 months after the baseline assessments.
We hypothesise that the mHealth delivery of the i-REBOUND programme will be feasible and acceptable in people post stroke/TIA living in rural and urban regions of Sweden. The results of this feasibility trial will inform the development of full-scale and appropriately powered trial to test the effects and costs of mHealth delivered physical activity for people after stroke or TIA.
ClinicalTrials.gov Identifier: NCT05111951. Registered November 8, 2021.
身体活动对于改善健康和降低中风或短暂性脑缺血发作（TIA）复发风险至关重要。然而，中风或 TIA 后患者通常身体活动不足，并且身体活动促进服务的可用性通常有限。本研究基于澳大利亚现有的远程医疗交付计划（i-REBOUND-让我们动起来），该计划为中风或 TIA 后患者提供家庭身体活动支持。本研究的目的是测试 i-REBOUND 计划的移动健康（mHealth）版本在瑞典居住的中风或 TIA 后患者中促进身体活动的可行性、可接受性和初步效果。
将通过广告招募 120 名中风或 TIA 患者。采用 1:1 分配比的平行组可行性随机对照试验设计，将患者分为 1）i-REBOUND 计划组，通过行为改变技术接受身体锻炼和支持，以维持身体活动的参与度，或 2）身体活动的行为改变技术组。两种干预措施都将持续六个月，并通过移动应用程序以数字方式进行交付。在整个研究过程中，将监测可行性结果（即，可及性、依从性、安全性和保真度）。可接受性将使用远程医疗可用性问卷进行评估，并通过对部分研究参与者和提供干预措施的物理治疗师进行定性访谈进一步探讨。干预初步效果的临床结果包括血压、身体活动参与度、自我感知的运动自我效能感、疲劳、抑郁、焦虑、压力和健康相关生活质量，并将在基线和基线评估后 3、6 和 12 个月进行测量。
我们假设 i-REBOUND 计划的 mHealth 交付在瑞典农村和城市地区的中风/TIA 后患者中是可行和可接受的。这项可行性试验的结果将为测试针对中风或 TIA 后患者的 mHealth 交付身体活动的效果和成本的全面和适当功率试验提供信息。
ClinicalTrials.gov 标识符：NCT05111951。于 2021 年 11 月 8 日注册。
