Denton Francesca, Waddell Alexander, Kite Chris, Hesketh Katie, Atkinson Lou, Cocks Matthew, Jones Helen, Randeva Harpal, Davenport Nathan, Powell Richard, Clark Cain, Kyrou Ioannis, Harwood Amy E, McGregor Gordon
Institute of Health and Wellbeing, Coventry University, Coventry, UK.
Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism (WISDEM), University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
Digit Health. 2023 Feb 15;9:20552076231152176. doi: 10.1177/20552076231152176. eCollection 2023 Jan-Dec.
Long-term adherence to exercise is often poor for people with coronary heart disease (CHD) who have completed supervised, centre-based cardiac rehabilitation. The aim of this study is to assess the feasibility of a remotely prescribed, delivered and monitored cardiac rehabilitation intervention using a wearable device to support long-term adherence to exercise and physical activity during maintenance of cardiac rehabilitation.
After completing cardiac rehabilitation, 30 participants with CHD, will be randomised (1:1) to an intervention ( = 15) or a usual care group ( = 15) in a 12-month feasibility randomised controlled trial (RCT). The intervention will comprise of an exercise consultation, personalised exercise prescription delivered via a wearable activity monitor using biometric feedback, regular monitoring via check-ins, and feedback text-messages for 6-months. Participants will be assessed at baseline (following completion of cardiac rehabilitation) and at three-, six-, and 12-months post-randomisation. The primary outcome will be feasibility, including assessment of eligibility, recruitment, adherence, and acceptability. Secondary outcomes will include exercise capacity, physical activity behaviours, cardiovascular disease risk and quality of life. Semi-structured interviews will be conducted at three-, six-, and 12-months post-randomisation (and with those who drop-out) to explore the acceptability of the study intervention and procedures. A questionnaire will be offered to those who decline participation.
The MAINTAIN study will evaluate the feasibility of conducting a future definitive multi-centre RCT testing a remotely prescribed and monitored long-term mHealth maintenance exercise programme, versus usual care, for people with CHD who have completed cardiac rehabilitation.
ClinicalTrials.gov, NCT05292287. Registered on 22/03/2022.
对于完成了有监督的、基于中心的心脏康复的冠心病患者，长期坚持锻炼的情况往往较差。本研究的目的是评估一种使用可穿戴设备远程开具、提供和监测的心脏康复干预措施的可行性，以支持在心脏康复维持阶段长期坚持锻炼和身体活动。
在一项为期12个月的可行性随机对照试验（RCT）中，30名冠心病患者在完成心脏康复后，将被随机（1:1）分为干预组（n = 15）或常规护理组（n = 15）。干预措施将包括一次运动咨询、通过可穿戴活动监测器利用生物特征反馈提供个性化运动处方、通过签到进行定期监测以及为期6个月的反馈短信。参与者将在基线（心脏康复完成后）以及随机分组后的3个月、6个月和12个月进行评估。主要结局将是可行性，包括对入选资格、招募、依从性和可接受性的评估。次要结局将包括运动能力、身体活动行为、心血管疾病风险和生活质量。将在随机分组后的3个月、6个月和12个月（以及对退出者）进行半结构化访谈，以探讨研究干预措施和程序的可接受性。将向拒绝参与的人提供一份问卷。
MAINTAIN研究将评估未来进行一项确定性多中心RCT的可行性，该RCT将测试一种针对完成心脏康复的冠心病患者的远程开具和监测的长期移动健康维持运动计划与常规护理相比的效果。
ClinicalTrials.gov，NCT05292287。于2022年3月22日注册。
