等待心脏移植患者的心血管康复-解决临床需求(PREHAB HTx研究)

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
Jennifer L. Reed R. Kin, PhD , Heather E. Tulloch PhD , Heather Ross MD , Tasuku Terada PhD , Matheus Mistura MSc , Isabela Roque Marçal MSc , Paul Oh MD , Sharon Chih MBBS, PhD
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引用次数: 0

摘要

比较12周预康复(PREHAB)计划与常规护理(UC)对心脏移植成人功能能力的影响。次要目的包括比较摄氧量峰值(V˙o2峰值)、虚弱程度、身体活动、心理健康、认知功能、生活质量(QoL)和饮食习惯。方法采用多中心随机对照试验。参与者随机分为PREHAB组和UC组。为期12周的PREHAB项目包括每周两次的高强度间歇训练,使用直立式自行车测力计,一次压力管理课程和一次营养研讨会。主要终点是从基线到12周随访的功能能力(6分钟步行测试距离)。次要结局包括V˙o2峰值、虚弱、身体活动、焦虑、抑郁和压力的严重程度、认知功能、生活质量和饮食习惯的变化。结果试验招募于2018年10月开始,由于COVID-19大流行,于2020年10月结束。在筛选出的84例患者中,17例被招募(年龄:44±9岁,71%为男性),4例被随机分组(PREHAB = 2;Uc = 2)。2例患者完成PREHAB, 1例患者完成UC。在整个试验过程中退出的原因包括:接受移植;药物和器械禁忌症;承诺和旅行限制;以及缺乏兴趣。PREHAB显示出改善6分钟步行测试距离的潜力(基线[B]: 343±120;随访[FU]: 465 m), V˙o2峰(B: 14.9±0.1;FU: 15.8±0.4 mL/kg/min),使用明尼苏达心力衰竭患者生活问卷测量生活质量(B: 41±33;FU: 26±1分)。结论在心脏移植患者中招募并完成PREHAB是具有挑战性的。考虑到等待时间的限制,未来的研究应审查在上市后不久提供的替代PREHAB方案,以解决所报告的参与障碍。临床试验注册号nct02957955。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation— Addressing Clinical Needs (the PREHAB HTx Study)

Background

To compare the effects of a 12-week prehabilitation (PREHAB) program vs usual care (UC) on functional capacity in adults listed for heart transplantation. Secondary aims included comparing peak oxygen uptake (V˙O2peak), frailty, physical activity, mental health, cognitive function, quality of life (QoL), and dietary habits.

Methods

A multicentre randomized controlled trial was conducted. Participants were randomized to PREHAB or UC. The 12-week PREHAB program included twice weekly high-intensity interval training sessions on an upright cycle ergometer, a stress management course, and a nutrition workshop. The primary outcome was functional capacity (6-minute walk test distance) from baseline to 12 weeks of follow-up. Secondary outcomes included changes in V˙O2peak, frailty, physical activity, severity of anxiety, depression, and stress, cognitive function, QoL, and dietary habits.

Results

Trial recruitment began in October 2018 and closed, due to the COVID-19 pandemic, in October 2020. Of 84 patients screened, 17 were recruited (age: 44 ± 9 years, 71% male), and 4 were randomized (PREHAB = 2; UC = 2). Both patients completed PREHAB, and 1 patient completed UC. Reasons for dropout throughout the trial included the following: receiving a transplant; medication and device contraindications; commitment and travel constraints; and lack of interest. PREHAB showed potential for improvements in the 6-minute walk test distance (Baseline [B]: 343 ± 120; follow-up [FU]: 465 m), V˙O2peak (B: 14.9 ± 0.1; FU: 15.8 ± 0.4 mL/kg/min), and QoL measured using the Minnesota Living with Heart Failure Questionnaire (B: 41 ± 33; FU: 26 ± 1 points).

Conclusions

Recruitment for and completion of PREHAB for patients listed for heart transplantation proved challenging. Given wait-time limitations, future research should examine alternative PREHAB programming, offered sooner following listing, that addresses reported barriers to participation.

Clinical Trial Registration

NCT02957955.
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来源期刊
CJC Open
CJC Open Medicine-Cardiology and Cardiovascular Medicine
CiteScore
3.30
自引率
0.00%
发文量
143
审稿时长
60 days
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