Claes Jomme, Cornelissen Véronique, McDermott Clare, Moyna Niall, Pattyn Nele, Cornelis Nils, Gallagher Anne, McCormack Ciara, Newton Helen, Gillain Alexandra, Budts Werner, Goetschalckx Kaatje, Woods Catherine, Moran Kieran, Buys Roselien
Physiotherapy Department, University Hospitals Leuven, Leuven, Belgium.
Department of Rehabilitation Sciences, University of Leuven, Leuven, Belgium.
J Med Internet Res. 2020 Feb 4;22(2):e14221. doi: 10.2196/14221.
Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon.
The Physical Activity Toward Health (PATHway) system was developed to provide a comprehensive, remotely monitored, home-based CR program for CVD patients. The PATHway-I study aimed to investigate its feasibility and clinical efficacy during phase III CR.
Participants were randomized on a 1:1 basis to the PATHway (PW) intervention group or usual care (UC) control group in a single-blind, multicenter, randomized controlled pilot trial. Outcomes were assessed at completion of phase II CR and 6-month follow-up. The primary outcome was physical activity (PA; Actigraph GT9X link). Secondary outcomes included measures of physical fitness, modifiable cardiovascular risk factors, endothelial function, intima-media thickness of the common carotid artery, and quality of life. System usability and patients' experiences were evaluated only in PW. A mixed-model analysis of variance with Bonferroni adjustment was used to analyze between-group effects over time. Missing values were handled by means of an intention-to-treat analysis. Statistical significance was set at a 2-sided alpha level of .05. Data are reported as mean (SD).
A convenience sample of 120 CVD patients (mean 61.4 years, SD 13.5 years; 22 women) was included. The PATHway system was deployed in the homes of 60 participants. System use decreased over time and system usability was average with a score of 65.7 (SD 19.7; range 5-100). Moderate-to-vigorous intensity PA increased in PW (PW: 127 [SD 58] min to 141 [SD 69] min, UC: 146 [SD 66] min to 143 [SD 71] min; P=.04; effect size of 0.42), while diastolic blood pressure (PW: 79 [SD 11] mmHg to 79 [SD 10] mmHg, UC: 78 [SD 9] mmHg to 83 [SD 10] mmHg; P=.004; effect size of -0.49) and cardiovascular risk score (PW: 15.9% [SD 10.4%] to 15.5% [SD 10.5%], UC: 14.5 [SD 9.7%] to 15.7% [SD 10.9%]; P=.004; effect size of -0.36) remained constant, but deteriorated in UC.
This pilot study demonstrated the feasibility and acceptability of a technology-enabled, remotely monitored, home-based CR program. Although clinical effectiveness was demonstrated, several challenges were identified that could influence the adoption of PATHway.
ClinicalTrials.gov NCT02717806; https://clinicaltrials.gov/ct2/show/NCT02717806.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2017-016781.
心脏康复（CR）作为心血管疾病（CVD）二级预防措施具有高效性。CR的接受率仍不理想（仅30%符合条件的患者接受），而长期坚持积极的生活方式的比例更低。需要创新策略来应对这一现象。
开发了“迈向健康的身体活动（PATHway）”系统，为CVD患者提供全面、远程监测的居家CR项目。PATHway-I研究旨在调查其在心脏康复第三阶段的可行性和临床疗效。
在一项单盲、多中心、随机对照试验中，参与者按1:1比例随机分配至PATHway（PW）干预组或常规护理（UC）对照组。在心脏康复第二阶段结束时和6个月随访时评估结果。主要结果是身体活动（PA；Actigraph GT9X链接）。次要结果包括体能指标、可改变的心血管危险因素、内皮功能、颈总动脉内膜中层厚度和生活质量。仅在PW组评估系统可用性和患者体验。采用带有Bonferroni校正的方差混合模型分析来分析组间随时间的效应。通过意向性分析处理缺失值。设定双侧α水平为0.05的统计学显著性。数据报告为均值（标准差）。
纳入了120名CVD患者的便利样本（平均61.4岁，标准差13.5岁；22名女性）。PATHway系统部署在60名参与者家中。系统使用随时间减少，系统可用性为中等水平，得分为65.7（标准差19.7；范围5 - 100）。PW组中高强度身体活动增加（PW组：从127[标准差58]分钟增加到141[标准差69]分钟，UC组：从146[标准差66]分钟增加到143[标准差71]分钟；P = 0.04；效应大小为0.42），而舒张压（PW组：从79[标准差11]mmHg降至79[标准差10]mmHg，UC组：从78[标准差9]mmHg升至83[标准差10]mmHg；P = 0.004；效应大小为 - 0.49）和心血管风险评分（PW组：从15.9%[标准差10.4%]降至15.5%[标准差10.5%]，UC组：从14.5[标准差9.7%]升至15.7%[标准差10.9%]；P = 0.004；效应大小为 - 0.36）保持不变，但UC组恶化。
这项初步研究证明了一项基于技术、远程监测的居家CR项目的可行性和可接受性。尽管证明了临床有效性，但也发现了一些可能影响PATHway采用的挑战。
ClinicalTrials.gov NCT02717806；https://clinicaltrials.gov/ct2/show/NCT02717806。
国际注册报告识别码（IRRID）：RR2 - 10.1136/bmjopen - 2017 - 016781。
