Dodson John A, Adhikari Samrachana, Schoenthaler Antoinette, Hochman Judith S, Sweeney Greg, George Barbara, Marzo Kevin, Jennings Lee A, Kovell Lara C, Vorsanger Matthew, Pena Stephanie, Meng Yuchen, Varghese Ashwini, Johanek Camila, Rojas Michelle, McConnell Riley, Whiteson Jonathan, Troxel Andrea B
New York University Langone Medical Center, New York.
Geriatrics and Palliative Medicine, College of Medicine, The University of Oklahoma Health Sciences Center, Oklahoma City.
JAMA Netw Open. 2025 Jan 2;8(1):e2453499. doi: 10.1001/jamanetworkopen.2024.53499.
Among older adults with ischemic heart disease, participation in traditional ambulatory cardiac rehabilitation (CR) remains low. While mobile health CR (mHealth-CR) provides a novel opportunity to deliver care, age-specific impairments to technology use may limit uptake, and efficacy data are currently lacking.
To test whether mHealth-CR improves functional capacity in older adults.
DESIGN, SETTING, AND PARTICIPANTS: The RESILIENT phase 2, multicenter, randomized clinical trial recruited patients aged 65 years or older with ischemic heart disease (defined as a hospital visit for myocardial infarction or coronary revascularization) from 5 academic hospitals in New York, Connecticut, and Massachusetts between January 9, 2020, and April 22, 2024.
Participants were randomized 3:1 to mHealth-CR or usual care. mHealth-CR consisted of commercially available software delivered on a tablet computer, coupled with remote monitoring and weekly exercise therapist telephone calls, delivered over a 3-month duration. As RESILIENT was a trial conducted in a routine care setting to inform decision-making, participants in both arms were also allowed to receive traditional CR at their cardiologist's discretion.
The primary outcome was change from baseline to 3 months in functional capacity, measured by 6-minute walk distance (6MWD). Secondary outcomes were health status (12-Item Short Form Health Survey [SF-12]), residual angina, and impairment in activities of daily living.
A total of 400 participants (median age, 71.0 years [range, 65.0-91.0 years]; 291 [72.8%] male) were randomized to mHealth-CR (n = 298) or usual care (n = 102) and included in the intention-to-treat analysis. Of those, 356 participants (89.0%) returned in person for 6MWD assessment at 3 months. For the primary outcome, there was no adjusted difference in 6MWD between participants receiving mHealth-CR vs usual care (15.6 m; 95% CI, -0.3 to 31.5 m; P = .06). Among subgroups, there was an improvement in 6MWD among women (36.6 m; 95% CI, 8.7-64.4 m). There were no differences in any secondary outcomes between groups (eg, adjusted difference in SF-12 physical component scores at 3 months: -1.9 points; 95% CI, -3.9 to 0.2 points). Based on inverse propensity score weighting, there was no effect of mHealth-CR on 6MWD among those who did not attend traditional CR (25.7 m; 95% CI, -8.7 to 60.2 m).
In this randomized clinical trial of mHealth-CR vs usual care, mHealth-CR did not significantly increase 6MWD or result in improvements in secondary outcomes. The findings suggest the older adult population may require more age-tailored mHealth strategies to effectively improve outcomes.
ClinicalTrials.gov Identifier: NCT03978130.
在患有缺血性心脏病的老年人中,参与传统门诊心脏康复(CR)的比例仍然很低。虽然移动健康心脏康复(mHealth-CR)提供了一种提供护理的新机会,但特定年龄的技术使用障碍可能会限制其采用率,而且目前缺乏疗效数据。
测试mHealth-CR是否能改善老年人的功能能力。
设计、设置和参与者:RESILIENT 2期多中心随机临床试验从纽约、康涅狄格州和马萨诸塞州的5家学术医院招募了65岁及以上患有缺血性心脏病(定义为因心肌梗死或冠状动脉血运重建而住院就诊)的患者,时间为2020年1月9日至2024年4月22日。
参与者按3:1随机分配至mHealth-CR组或常规护理组。mHealth-CR包括在平板电脑上提供的商业软件,以及远程监测和每周一次的运动治疗师电话随访,为期3个月。由于RESILIENT是在常规护理环境中进行的一项试验,以提供决策依据,两组参与者也可根据心脏病专家的判断接受传统CR。
主要结局是从基线到3个月时功能能力的变化,通过6分钟步行距离(6MWD)来衡量。次要结局包括健康状况(12项简短健康调查[SF-12])、残余心绞痛和日常生活活动障碍。
共有400名参与者(中位年龄71.0岁[范围65.0 - 91.0岁];291名[72.8%]为男性)被随机分配至mHealth-CR组(n = 298)或常规护理组(n = 102),并纳入意向性分析。其中,356名参与者(89.0%)在3个月时亲自返回进行6MWD评估。对于主要结局,接受mHealth-CR的参与者与接受常规护理的参与者在6MWD方面没有调整后的差异(15.6米;95%置信区间,-0.3至31.5米;P = 0.06)。在亚组中,女性的6MWD有所改善(36.6米;95%置信区间,8.7 - 64.4米)。两组之间在任何次要结局方面均无差异(例如,3个月时SF-12身体成分评分的调整差异:-1.9分;95%置信区间,-