Anesthesiology and Pain Medicine, Ottawa Hospital Research Institute Clinical Epidemiology Program, Ottawa, Ontario, Canada
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
BMJ Open. 2022 Aug 8;12(8):e064165. doi: 10.1136/bmjopen-2022-064165.
Frailty is a strong predictor of adverse postoperative outcomes. Prehabilitation may improve outcomes after surgery for older people with frailty by addressing physical and physiologic deficits. The objective of this trial is to evaluate the efficacy of home-based multimodal prehabilitation in decreasing patient-reported disability and postoperative complications in older people with frailty having major surgery.
We will conduct a multicentre, randomised controlled trial of home-based prehabilitation versus standard care among consenting patients >60 years with frailty (Clinical Frailty Scale4) having elective inpatient major non-cardiac, non-neurologic or non-orthopaedic surgery. Patients will be partially blinded; clinicians and outcome assessors will be fully blinded. The intervention consists of 3 weeks of prehabilitation (exercise (strength, aerobic and stretching) and nutrition (advice and protein supplementation)). The study has two primary outcomes: in-hospital complications and patient-reported disability 30 days after surgery. Secondary outcomes include survival, lower limb function, quality of life and resource utilisation. A sample size of 750 participants (375 per arm) provides >90% power to detect a minimally important absolute difference of 8 on the 100-point patient-reported disability scale and a 25% relative risk reduction in complications, using a two-sided alpha value of 0.025 to account for the two primary outcomes. Analyses will follow intention to treat principles for all randomised participants. All participants will be followed to either death or up to 1 year.
Ethical approval has been granted by Clinical Trials Ontario (Project ID: 1785) and our ethics review board (Protocol Approval #20190409-01T). Results will be disseminated through presentation at scientific conferences, through peer-reviewed publication, stakeholder organisations and engagement of social and traditional media.
NCT04221295.
衰弱是不良术后结局的有力预测因素。预康复可以通过解决身体和生理缺陷，改善衰弱老年人手术后的结局。本试验的目的是评估家庭为基础的多模式预康复对减少衰弱患者主要手术后患者报告的残疾和术后并发症的效果。
我们将对同意进行择期住院非心脏、非神经或非骨科大手术的 60 岁以上衰弱（临床虚弱量表 4 级）患者进行家庭为基础的预康复与标准护理的多中心、随机对照试验。患者将部分接受盲法；临床医生和结局评估者将完全接受盲法。干预措施包括 3 周的预康复（运动（力量、有氧和伸展）和营养（建议和蛋白质补充））。该研究有两个主要结局：住院期间并发症和手术后 30 天患者报告的残疾。次要结局包括生存、下肢功能、生活质量和资源利用。750 名参与者（每组 375 名）的样本量提供了 >90%的效能，以检测 100 分患者报告残疾量表上 8 分的最小临床重要差异和并发症的 25%相对风险降低，使用双侧 alpha 值 0.025 来考虑两个主要结局。所有随机参与者都将按照意向治疗原则进行分析。所有参与者将随访至死亡或最长 1 年。
临床试验安大略省（项目 ID：1785）和我们的伦理审查委员会（协议批准号 20190409-01T）已批准伦理。结果将通过在科学会议上的演讲、同行评议出版物、利益相关者组织以及社会和传统媒体的参与来传播。
NCT04221295。
