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等待心脏移植患者的心血管预康复——满足临床需求(PREHAB HTx研究)

Cardiovascular Prehabilitation in Patients Awaiting Heart Transplantation- Addressing Clinical Needs (the PREHAB HTx Study).

作者信息

Reed Jennifer L, Tulloch Heather E, Ross Heather, Terada Tasuku, Mistura Matheus, Marçal Isabela Roque, Oh Paul, Chih Sharon

机构信息

University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada.

出版信息

CJC Open. 2025 May 22;7(8):1110-1119. doi: 10.1016/j.cjco.2025.05.009. eCollection 2025 Aug.

Abstract

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 ( Opeak), 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 Opeak, 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), Opeak (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.

摘要

背景

比较为期12周的术前康复(PREHAB)计划与常规护理(UC)对等待心脏移植的成年人功能能力的影响。次要目标包括比较峰值摄氧量(Opeak)、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

进行了一项多中心随机对照试验。参与者被随机分配到PREHAB或UC组。为期12周的PREHAB计划包括每周两次在直立式自行车测力计上进行高强度间歇训练课程、一个压力管理课程和一个营养研讨会。主要结局是从基线到随访12周的功能能力(6分钟步行试验距离)。次要结局包括Opeak、虚弱程度、身体活动、焦虑、抑郁和压力的严重程度、认知功能、QoL和饮食习惯的变化。

结果

试验招募于2018年10月开始,由于2019冠状病毒病大流行,于2020年10月结束。在84名筛查的患者中,17名被招募(年龄:44±9岁,71%为男性),4名被随机分组(PREHAB = 2;UC = 2)。两名患者完成了PREHAB,一名患者完成了UC。整个试验期间退出的原因包括:接受移植;药物和设备禁忌;承诺和旅行限制;以及缺乏兴趣。PREHAB显示出在6分钟步行试验距离(基线[B]:343±120;随访[FU]:465米)、Opeak(B:14.9±0.1;FU:15.8±0.4毫升/千克/分钟)以及使用明尼苏达心力衰竭生活问卷测量的QoL(B:41±33;FU:26±1分)方面有改善的潜力。

结论

事实证明,为等待心脏移植的患者进行PREHAB招募和完成具有挑战性。鉴于等待时间的限制,未来的研究应探讨在列入名单后更早提供的替代PREHAB方案,该方案应解决所报告的参与障碍。

临床试验注册

NCT02957955。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6c97/12399121/026192288314/gr1.jpg

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