School of Health Sciences, University of Newcastle, Newcastle, New South Wales, Australia.
Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Newcastle, New South Wales, Australia.
Cerebrovasc Dis. 2021;50(5):605-611. doi: 10.1159/000515689. Epub 2021 Apr 23.
Increasing physical activity (PA) and improving diet quality are opportunities to improve secondary stroke prevention, but access to appropriate services is limited. Interventions co-designed with stroke survivors and delivered by telehealth are a potential solution.
The aim of this study is to test the feasibility, safety, and potential efficacy of a 6-month, telehealth-delivered PA and/or dietary (DIET) intervention.
Pilot randomized trial. 80 adults with previous stroke who are living at home with Internet access and able to exercise will be randomized in a 2 × 2 factorial (4-arm) pilot randomized, open-label, blinded outcome assessment trial to receive PA, DIET, PA + DIET, or control interventions via telehealth. The PA intervention aims to support participants to meet the minimum recommended levels of PA (150 min/week moderate exercise), and the DIET intervention aims to support participants to follow the AusMed (Mediterranean-style) diet. The control group receives usual care plus education about PA and healthy eating. The co-primary outcomes are feasibility (proportion and characteristics of eligible participants enrolled and proportion of scheduled intervention sessions attended) and safety (adverse events) at 6 months. The secondary outcomes include recurrent stroke risk factors (blood pressure, physical activity levels, and diet quality), fatigue, mood, and quality of life. Outcomes are measured at 3, 6, and 12 months.
This trial will produce evidence for the feasibility, safety, and potential effect of telehealth-delivered PA and DIET interventions for people with stroke. Results will inform development of an appropriately powered trial to test effectiveness to reduce major risk factors for recurrent stroke.
ACTRN12620000189921.
增加身体活动（PA）和改善饮食质量是改善二级中风预防的机会，但获得适当的服务是有限的。与中风幸存者共同设计并通过远程医疗提供的干预措施是一种潜在的解决方案。
本研究旨在测试为期 6 个月的远程医疗提供的 PA 和/或饮食（DIET）干预措施的可行性、安全性和潜在疗效。
试点随机试验。80 名有既往中风史、居住在有互联网接入的家中且能够进行锻炼的成年人将被随机分为 2×2 析因（4 臂）试验，即接受 PA、DIET、PA+DIET 或远程医疗控制干预。PA 干预旨在支持参与者达到最低推荐 PA 水平（每周 150 分钟中度运动），DIET 干预旨在支持参与者遵循 AusMed（地中海式）饮食。对照组接受常规护理和关于 PA 和健康饮食的教育。主要结局是 6 个月时的可行性（合格参与者的比例和特征、计划干预课程的参与比例）和安全性（不良事件）。次要结局包括复发性中风危险因素（血压、身体活动水平和饮食质量）、疲劳、情绪和生活质量。结果在 3、6 和 12 个月时进行测量。
该试验将为远程医疗提供的 PA 和 DIET 干预措施对中风患者的可行性、安全性和潜在效果提供证据。结果将为开发适当的功效试验提供信息，以测试降低复发性中风主要危险因素的效果。
ACTRN12620000189921。
