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等待急性住院心脏手术患者的多模式术前康复:一项初步可行性试验(PreP-ACe)的研究方案

Multimodal prehabilitation in people awaiting acute inpatient cardiac surgery: Study protocol for a pilot feasibility trial (PreP-ACe).

作者信息

Raut Sarah, Hales Aaron, Twiddy Maureen, Dixon Lili, Ngaage Dumbor, Yates David, Danjoux Gerard, Ingle Lee

机构信息

Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom.

Hull and York Medical School, University of Hull, Hull, United Kingdom.

出版信息

PLoS One. 2025 Mar 10;20(3):e0307341. doi: 10.1371/journal.pone.0307341. eCollection 2025.

DOI:10.1371/journal.pone.0307341
PMID:40063583
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11892877/
Abstract

BACKGROUND

The concept of "prehabilitation," or optimising individual physical and mental wellbeing prior to surgery is well established in cancer and orthopaedic populations. However, amongst the cardiac surgery population, the concept is relatively new. Of the few studies available, all focus on the elective surgical population. This pilot feasibility trial is novel as it will focus on the impact of multimodal prehabilitation on the acute inpatient cardiac surgical population.

METHODS

This single centre, prospective, single arm pilot feasibility trial will recruit 20 inpatients awaiting cardiac surgery. Measurements will be collected at the start of the trial (baseline), 7 days after intervention, and 14 days after the intervention or before the day of surgery. The primary outcome measure will be feasibility and practicality of the programme in an acute inpatient population. We will be looking into participant eligibility, acceptability, recruitment rates, completion rates and barriers to implementing a prehabilitation programme. Secondary outcomes include incidence of study-related adverse events, improvement in 6 minutes walk test (6MWT), hand grip strength, quality of life, anxiety scores and spirometry. At the end of the trial, we will be seeking the feedback of the participants on key components of the programme to help us inform future work. We hypothesise that light to moderate structured exercise training is low risk and feasible in patients awaiting inpatient cardiac surgery. The study was approved by Health Research Authority and Heath and Care Research Wales (Yorkshire & the Humber- Bradford Leeds Research Ethics Committee: REC reference 23/YH/0255) on the 8th November 2023.

DISCUSSION

Multimodal prehabilitation could improve individual physical and mental wellbeing whilst awaiting inpatient cardiac surgery. Prehabilitation can provide individuals with a sense of ownership and control over their condition, improve their motivation and independence, and enhance their mental and physical recovery after surgery. Traditionally, patients waiting for cardiac surgery are discouraged from physical activity/ structured exercise training and receive limited information regarding their health. Appropriate physical and psychological support could improve their confidence to mobilise sooner after surgery. This may then facilitate earlier discharge leading to improved hospital bed utilisation and patient flow.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06275100.

摘要

背景

“术前康复”的概念,即在手术前优化个体身心健康,在癌症和骨科患者群体中已得到充分确立。然而,在心脏手术患者群体中,这一概念相对较新。在现有的少数研究中,所有研究都集中在择期手术患者群体上。这项试点可行性试验具有创新性,因为它将关注多模式术前康复对急性住院心脏手术患者群体的影响。

方法

这项单中心、前瞻性、单臂试点可行性试验将招募20名等待心脏手术的住院患者。在试验开始时(基线)、干预后7天以及干预后14天或手术前一天收集测量数据。主要结局指标将是该方案在急性住院患者群体中的可行性和实用性。我们将研究参与者的 eligibility、可接受性、招募率、完成率以及实施术前康复方案的障碍。次要结局包括与研究相关的不良事件发生率、6分钟步行试验(6MWT)、握力、生活质量、焦虑评分和肺活量测定的改善情况。在试验结束时,我们将征求参与者对该方案关键组成部分的反馈,以帮助我们为未来的工作提供信息。我们假设轻度至中度的结构化运动训练在等待住院心脏手术的患者中风险较低且可行。该研究于2023年11月8日获得健康研究管理局以及威尔士健康与护理研究机构(约克郡与亨伯-布拉德福德利兹研究伦理委员会:REC编号23/YH/0255)的批准。

讨论

多模式术前康复可以在等待住院心脏手术期间改善个体身心健康。术前康复可以为个体提供对自身病情的主人翁意识和掌控感,提高他们的积极性和独立性,并增强他们术后的身心恢复。传统上,等待心脏手术的患者不被鼓励进行体育活动/结构化运动训练,并且获得的关于其健康状况的信息有限。适当的身体和心理支持可以提高他们术后更快活动的信心。这进而可能促进更早出院,从而提高医院病床利用率和患者流量。

试验注册

ClinicalTrials.gov NCT06275100。

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本文引用的文献

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Prehabilitation of Cardiac Surgical Patients, Part 1: Anemia, Diabetes Mellitus, Obesity, Sleep Apnea, and Cardiac Rehabilitation.心脏外科患者的预康复,第 1 部分:贫血、糖尿病、肥胖、睡眠呼吸暂停和心脏康复。
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