Thurston Charlotte, Humphries Sophia, Bezuidenhout Lucian, Johansson Sverker, Holmlund Lisa, von Koch Lena, English Coralie, Moulaee Conradsson David
Division of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
Women's Health and Allied Health Professionals Theme, Medical Unit Allied Health Professionals, Karolinska University Hospital, Stockholm, Sweden.
Int J Stroke. 2025 Aug;20(7):801-811. doi: 10.1177/17474930251315628. Epub 2025 Jan 30.
Physical activity is a key component of secondary stroke prevention. Mobile health (mHealth) interventions show promise for enhancing post-stroke physical activity, but most studies have combined mHealth with onsite services. This study evaluated the feasibility and acceptability of a fully digitalized mHealth intervention for physical activity among individuals post-stroke or transient ischemic attack (TIA) in Sweden.
In this two-arm feasibility randomized controlled trial, adults with stroke or TIA were randomized to one of the following 6-month interventions: (1) the experiment group, receiving mHealth-delivered supervised exercise (two sessions weekly during months 1 to 3, one session weekly during months 4 to 6) and behavioral change techniques for physical activity (including two individual counseling and six follow-up sessions) or (2) the control group, receiving two mHealth-delivered individual counseling and three follow-up sessions. Feasibility (reach, retention, adherence, fidelity, safety) and acceptability were assessed according to pre-specified progression criteria.
Of 114 participants, 105 (92%) completed the 6-month intervention and 102 (89%) completed the 12-month follow-up assessment. The intervention reached individuals from 20 of 21 Swedish regions. Sixty-eight percent of participants had a stroke (of which 96% were mild), 64% were female, and the average age was 71 years (standard deviation = 9). Ninety-five percent were born in Sweden, had a high level of education (61%), and an average daily step count of 6451 steps. Completion of outcome measures included digital questionnaires (98%), sensor-derived physical activity (92%), and blood pressure monitoring (97%). A total of 1781 supervised exercise sessions were delivered to the experiment group, with an adherence rate of 76%, and adherence to individual counseling and follow-up sessions was 96%. Ninety-five adverse events were recorded, of which 16 were related to the intervention (predominantly pain or muscle soreness) but non-serious. Overall satisfaction with the mobile app was 71%, and 76% of the experiment group believed the app could partly replicate in-person visits.
The mHealth intervention was overall feasible and acceptable; however, there is a need to develop recruitment procedures to increase diversity of included participants regarding socioeconomic status and physical activity level, prior to a phase 3 trial.
ClinicalTrials.gov (NCT05111951).
体育活动是二级卒中预防的关键组成部分。移动健康（mHealth）干预措施在增强卒中后体育活动方面显示出前景，但大多数研究将移动健康与现场服务相结合。本研究评估了一项针对瑞典卒中或短暂性脑缺血发作（TIA）患者进行体育活动的全数字化移动健康干预措施的可行性和可接受性。
在这项双臂可行性随机对照试验中，患有卒中或TIA的成年人被随机分配到以下6个月干预措施之一：（1）实验组，接受移动健康提供的监督锻炼（第1至3个月每周两次，第4至6个月每周一次）以及体育活动行为改变技术（包括两次个体咨询和六次随访）；或（2）对照组，接受两次移动健康提供的个体咨询和三次随访。根据预先指定的进展标准评估可行性（覆盖范围、留存率、依从性、保真度、安全性）和可接受性。
114名参与者中，105名（92%）完成了6个月的干预，102名（89%）完成了12个月的随访评估。干预覆盖了瑞典21个地区中的20个地区的个体。68%的参与者曾患卒中（其中96%为轻度），64%为女性，平均年龄为71岁（标准差 = 9）。95%的参与者出生在瑞典，教育程度较高（61%），平均每日步数为6451步。结局指标的完成情况包括数字问卷（98%）、传感器测量的体育活动（92%）和血压监测（97%）。实验组共进行了1781次监督锻炼课程，依从率为76%，个体咨询和随访的依从率为96%。记录了95起不良事件，其中16起与干预相关（主要是疼痛或肌肉酸痛），但不严重。对移动应用程序的总体满意度为71%，76%的实验组认为该应用程序可以部分替代面对面就诊。
移动健康干预总体上是可行且可接受的；然而，在进行3期试验之前，需要制定招募程序，以增加纳入参与者在社会经济地位和体育活动水平方面的多样性。
ClinicalTrials.gov（NCT05111951）。
