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基于行为改变的移动干预在促进冠心病患者医学康复维持期规律体力活动中的应用:一项对照试验。

A Behavioral Change-Based Mobile Intervention for Promoting Regular Physical Activity in Medical Rehabilitation Maintenance of Patients With Coronary Artery Disease: Controlled Trial.

机构信息

Department of Rehabilitation Sciences, Faculty of Health, University of Witten/Herdecke, Witten, Germany.

DRV Clinic Königsfeld, Center for Medical Rehabilitation, Ennepetal, Germany.

出版信息

J Med Internet Res. 2024 Oct 8;26:e56480. doi: 10.2196/56480.

Abstract

BACKGROUND

Cardiac rehabilitation is known to reduce coronary artery disease (CAD) severity and symptoms, but adoption of a healthy postrehabilitation lifestyle remains challenging. Innovative eHealth solutions could help, but behavioral change-based eHealth maintenance programs for patients with CAD are scarce. RehaPlus+ aims to improve postrehabilitation outcomes with a personalized eHealth intervention built on behavioral change concepts emphasizing healthy lifestyle changes, especially regular physical activity (PA).

OBJECTIVE

This study aims to evaluate the effectiveness of the personalized eHealth program RehaPlus+ for promoting regular PA against usual care.

METHODS

A total of 169 patients with CAD who had undergone stent implantation or bypass surgery were recruited after completing center-based phase II rehabilitation. They were then divided, without blinding, into 2 groups using a quasi-experimental approach: a case manager-assisted 24-week eHealth program (RehaPlus+; n=84) and a conventional physician-assisted outpatient program (usual care; n=85). The study was designed as a noninferiority trial. RehaPlus+ participants received motivational messages twice weekly for 6 months, and the usual care group engaged in a 6-month outpatient program (twenty-four 90-minute strength and endurance training sessions). The primary outcomes, evaluated using the self-assessed Bewegungs- und Sportaktivität questionnaire, were regular PA (≥150 min/wk) and weekly activities of daily living (ADLs) 6 months after rehabilitation. Secondary outcomes involved PA during work and floors climbed weekly (measured by Bewegungs- und Sportaktivität questionnaire), psychological well-being (assessed by the 5-item World Health Organization Well-Being Index), cardiac self-efficacy, health-related quality of life (measured by the 36-Item Short Form Survey), and work ability (using the Work Ability Index).

RESULTS

Data of 105 patients (RehaPlus+: n=44, 41.9%; usual care: n=61, 58.1%; male patients: n=80, 76.2%; female patients: n=25, 23.8%; mean age 56.0, SD 7.3 years) were available at the 6-month follow-up. At 6 months after discharge from phase II cardiac rehabilitation, the RehaPlus+ group exhibited 182 (SD 208) minutes per week of PA and the usual care group exhibited 119 (SD 175) minutes per week of PA (P=.15), with no interaction effect (P=.12). The RehaPlus+ group showed an ADL level of 443 (SD 538) minutes per week compared to the usual care group with 308 (SD 412) minutes per week at the 6-month follow-up, with no interaction effect (P=.84). The differences observed in PA and ADL levels between the RehaPlus+ and usual care groups were within the predefined 1-sided noninferiority margin, indicating that the RehaPlus+ intervention is not inferior to usual care based on these outcomes. There were no differences between the groups for all secondary outcomes (P>.05).

CONCLUSIONS

RehaPlus+ is not inferior to the usual care program, as both groups improved PA and ADLs to a similar extent. These findings emphasize the potential of eHealth interventions to assist in maintaining healthy lifestyles after rehabilitation.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06162793; https://clinicaltrials.gov/study/NCT06162793.

摘要

背景

心脏康复可降低冠心病(CAD)的严重程度和症状,但采用健康的康复后生活方式仍然具有挑战性。创新的电子健康解决方案可能会有所帮助,但针对 CAD 患者的基于行为改变的电子健康维持方案却很少。RehaPlus+ 旨在通过基于强调健康生活方式改变(尤其是定期体育锻炼(PA))的行为改变概念的个性化电子健康干预措施来改善康复后的结果。

目的

本研究旨在评估个性化电子健康计划 RehaPlus+在促进常规 PA 方面相对于常规护理的有效性。

方法

在完成中心第二阶段康复后,共招募了 169 名接受过支架植入或旁路手术的 CAD 患者。然后,他们采用准实验方法分为两组,不进行盲法:一名案例经理协助的 24 周电子健康计划(RehaPlus+;n=84)和常规医生协助的门诊计划(常规护理;n=85)。该研究设计为非劣效性试验。RehaPlus+ 参与者每两周接受两次动机信息,为期 6 个月,而常规护理组则参加了 6 个月的门诊计划(24 次 90 分钟的力量和耐力训练课程)。主要结局通过自我评估的运动和体育活动问卷评估,康复后 6 个月定期进行 PA(≥150 min/wk)和每周日常生活活动(ADL)。次要结局包括工作期间和每周爬楼梯的 PA(通过运动和体育活动问卷测量)、心理健康(使用世界卫生组织幸福感量表评估)、心脏自我效能、健康相关生活质量(使用 36-项简短形式调查)和工作能力(使用工作能力指数)。

结果

在 6 个月的随访中,有 105 名患者(RehaPlus+:n=44,41.9%;常规护理:n=61,58.1%;男性患者:n=80,76.2%;女性患者:n=25,23.8%;平均年龄 56.0,SD 7.3 岁)的数据可用。在第二阶段心脏康复出院后 6 个月,RehaPlus+ 组每周进行 182(SD 208)分钟的 PA,常规护理组每周进行 119(SD 175)分钟的 PA(P=.15),无交互效应(P=.12)。RehaPlus+ 组每周 ADL 水平为 443(SD 538)分钟,而常规护理组为 308(SD 412)分钟,在 6 个月的随访中无交互效应(P=.84)。RehaPlus+ 和常规护理组之间观察到的 PA 和 ADL 水平的差异在预设的单侧非劣效性范围内,表明基于这些结果,RehaPlus+ 干预措施并不逊于常规护理。两组之间的所有次要结局均无差异(P>.05)。

结论

RehaPlus+ 并不逊于常规护理方案,因为两组都将 PA 和 ADLs 改善到相似的程度。这些发现强调了电子健康干预措施在康复后帮助维持健康生活方式的潜力。

试验注册

ClinicalTrials.gov NCT06162793; https://clinicaltrials.gov/study/NCT06162793.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4cd1/11496926/24c566b75d0b/jmir_v26i1e56480_fig1.jpg

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