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英国接受髋关节和膝关节置换手术的虚弱患者的预康复:一项随机对照试验的联合 PREP 可行性研究。

Prehabilitation for frail patients undergoing hip and knee replacement in the UK: Joint PREP feasibility study for a randomised controlled trial.

机构信息

Bristol Medical School, University of Bristol, Bristol, UK.

National Institute for Health and Care Research Applied Research Collaboration West at University Hospitals Bristol and Weston NHS Foundation Trust, United Kingdom, Bristol, UK.

出版信息

BMJ Open. 2024 Sep 17;14(9):e084678. doi: 10.1136/bmjopen-2024-084678.

Abstract

OBJECTIVE

To determine the feasibility of conducting a randomised controlled trial (RCT) to evaluate a prehabilitation programme for frail patients undergoing total hip replacement (THR) or total knee replacement (TKR).

DESIGN

Randomised feasibility study with embedded qualitative work.

SETTING

Three National Health Service hospitals.

PARTICIPANTS

Adults aged ≥65 years, frail and scheduled for primary THR or TKR.

INTERVENTION

Appointment with a physiotherapist to individualise a home-based exercise programme. Participants were encouraged to do the home exercises daily for 12 weeks pre-operative and were provided with a daily protein supplement. Participants were supported by six telephone calls over the 12-week intervention period.

OUTCOME MEASURES

Eligibility and recruitment rates, intervention adherence, data completion rates of patient-reported outcome measures, retention rates and acceptability of the trial and intervention. Qualitative interviews were conducted with participants and non-participants and analysed using thematic analysis.

RESULTS

Between December 2022 and August 2023, 411 patients were sent a screening pack. Of the 168 patients who returned a screening questionnaire, 79 were eligible and consented to participate, and 64 were randomised. Of the 33 participants randomised to the intervention, 26 attended the intervention appointment. Eighteen participants (69%) received all six intervention follow-up telephone calls. Nineteen participants (73%) completed an intervention adherence log; 13 (68%) adhered to the exercise programme and 11 (58%) adhered to the protein supplementation. The overall retention rate was 86% (55/64 overall) at 12 weeks. The 12-week follow-up questionnaire was returned by 46 of the 55 participants (84%) who were sent a questionnaire. Interviews with 19 patients found that the trial processes and intervention were generally acceptable, but areas of potential improvements were identified.

CONCLUSIONS

This study demonstrated that a larger study is possible and has identified improvements to optimise the design of an RCT.

TRIAL REGISTRATION NUMBER

ISRCTN11121506.

摘要

目的

确定开展一项随机对照试验(RCT)以评估虚弱患者接受全髋关节置换术(THR)或全膝关节置换术(TKR)的预康复计划的可行性。

设计

随机可行性研究,嵌入定性工作。

设置

三家国民保健制度医院。

参与者

年龄≥65 岁、虚弱且计划接受初次 THR 或 TKR 的成年人。

干预措施

预约物理治疗师制定个体化的家庭运动计划。鼓励参与者在术前 12 周内每天进行家庭锻炼,并提供每日蛋白质补充剂。在 12 周的干预期间,参与者接受了 6 次电话支持。

结果

2022 年 12 月至 2023 年 8 月期间,共向 411 名患者发送了筛选包。在返回筛选问卷的 168 名患者中,有 79 名符合条件并同意参与,64 名患者被随机分组。在随机分配到干预组的 33 名参与者中,26 名参加了干预预约。18 名参与者(69%)接受了所有 6 次干预随访电话。19 名参与者(73%)完成了干预依从性日志;13 名(68%)坚持了运动计划,11 名(58%)坚持了蛋白质补充。12 周时的总体保留率为 86%(55/64 人)。在被发送问卷的 55 名参与者中,有 46 名(84%)返回了 12 周随访问卷。对 19 名患者的访谈发现,试验过程和干预措施总体上是可以接受的,但也确定了一些可以改进的地方。

结论

本研究表明更大规模的研究是可行的,并确定了优化 RCT 设计的改进措施。

试验注册号

ISRCTN11121506。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/668d/11409239/1292c7047dc8/bmjopen-14-9-g001.jpg

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