Feasibility, acceptability, and clinical effectiveness of a technology-enabled cardiac rehabilitation platform (Physical Activity Toward Health-I): randomized controlled trial

摘要: BACKGROUND Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% eligible patients), and long-term adherence to a physically active lifestyle even lower. Innovative strategies are needed counteract this phenomenon. OBJECTIVE The Physical Activity Toward Health (PATHway) system was developed provide comprehensive, remotely monitored, home-based program CVD patients. PATHway-I study aimed investigate its feasibility clinical efficacy during phase III CR. METHODS Participants were randomized on 1:1 basis the PATHway (PW) intervention group or usual care (UC) control in single-blind, multicenter, controlled pilot trial. Outcomes assessed at completion II 6-month follow-up. primary outcome physical activity (PA; Actigraph GT9X link). Secondary outcomes included measures fitness, modifiable risk factors, endothelial function, intima-media thickness common carotid artery, quality life. System usability patients' experiences evaluated only PW. A mixed-model analysis variance with Bonferroni adjustment used analyze between-group effects over time. Missing values handled by means an intention-to-treat analysis. Statistical significance set 2-sided alpha level .05. Data reported mean (SD). RESULTS convenience sample 120 patients (mean 61.4 years, SD 13.5 years; 22 women) included. deployed homes 60 participants. use decreased time average score 65.7 (SD 19.7; range 5-100). Moderate-to-vigorous intensity PA increased PW (PW: 127 [SD 58] min 141 69] min, UC: 146 66] 143 71] min; Pinteraction=.04; effect size 0.42), while diastolic blood pressure 79 11] mmHg 10] mmHg, 78 9] 83 mmHg; Pinteraction=.004; -0.49) 15.9% 10.4%] 15.5% 10.5%], 14.5 9.7%] 15.7% 10.9%]; -0.36) remained constant, but deteriorated UC. CONCLUSIONS This demonstrated acceptability technology-enabled, program. Although effectiveness demonstrated, several challenges identified that could influence adoption PATHway. TRIAL REGISTRATION ClinicalTrials.gov NCT02717806; https://clinicaltrials.gov/ct2/show/NCT02717806. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1136/bmjopen-2017-016781.