Okpara Chinenye, Negm Ahmed, Adachi Jonathan Derrick, Armstrong David, Atkinson Stephanie, Avram Victoria, de Beer Justin, Hladysh Genevieve, Ioannidis George, Kennedy Courtney, Hewston Patricia, Lau Arthur, Lee Justin, Richardson Julie, Marr Sharon, Panju Akbar, Petruccelli Danielle, Thabane Lehana, Winemaker Mitchell, Papaioannou Alexandra
Department of Health Research Methodology, Evidence and Impact, McMaster University, Hamilton, ON, Canada.
Faculty of Rehabilitation Science, University of Alberta, Edmonton, AB, Canada.
J Frailty Aging. 2025 Apr;14(2):100028. doi: 10.1016/j.tjfa.2025.100028. Epub 2025 Mar 4.
Older adults with frailty have high risk for poor postoperative outcomes.
To evaluate the feasibility of a multimodal prehabilitation program in older adults with frailty awaiting hip or knee replacement.
Parallel two-arm randomized controlled pilot trial.
Community-dwelling older adults with frailty awaiting joint replacement aged ≥60 years recruited from the Musculoskeletal Central Intake and Assessment Centre (MSK CIAC), Ontario.
Exercise, protein and vitamin D supplements, and medication review.
Feasibility was assessed based on predefined progression criteria for recruitment, retention, data completion and adherence to intervention components. Clinical outcomes including Oxford Knee and Hip Scores, frailty index, Short Physical Performance Battery and health-related quality of life were collected at baseline, 1-week preoperative, 6-weeks and 6-months postoperative and were evaluated using generalized linear mixed models for repeated measures.
A total of 69 participants were enrolled. Recruitment rate was 35 %. Participants' mean age was 74 (standard deviation (SD): 7.5); 51 % were prefrail and 36 % were frail. Participant retention was 81 %, and data completion was ≥80 %. Mean adherence to strength exercises was 4 days (95 % confidence interval (CI): 3-5 days/week), balance 3 days (95 % CI: 2-4 days/week), and flexibility 3 days (95 % CI: 3-4 days/week). Adherence to vitamin D intake was 82 % (95 % CI: 73-92 %), and medication review consultation completion was 86 % (95 % CI: 68-95 %). These outcomes met the target values for feasibility success. The Oxford Knee Score at 6-months postoperative 8.78 (95 % CI: 0.40-17.16) showed a clinically meaningful and statistically significant difference between treatment groups. There were also indications of clinically relevant changes for frailty and quality of life post-surgery.
This trial provides strong evidence of feasibility and indications of improvements in postoperative clinical outcomes. Challenges to implementation and adherence were identified that can inform modifications to study design for future trials.
ClinicalTrials.gov NCT02885337. Registered August 31, 2016. https://classic.
gov/ct2/show/NCT02885337.
体弱的老年人术后预后不良风险较高。
评估多模式术前康复计划在等待髋关节或膝关节置换的体弱老年人中的可行性。
平行双臂随机对照试验。
从安大略省肌肉骨骼中央摄入与评估中心（MSK CIAC）招募的年龄≥60岁、等待关节置换的社区体弱老年人。
运动、蛋白质和维生素D补充剂以及药物审查。
根据招募、留存、数据完成情况以及对干预措施各组成部分的依从性的预定义进展标准评估可行性。在基线、术前1周、术后6周和6个月收集临床结局，包括牛津膝关节和髋关节评分、体弱指数、简短体能测试电池组以及健康相关生活质量，并使用广义线性混合模型进行重复测量评估。
共纳入69名参与者。招募率为35%。参与者的平均年龄为74岁（标准差（SD）：7.5）；51%为轻度体弱，36%为体弱。参与者留存率为81%，数据完成率≥80%。力量训练的平均依从性为4天（95%置信区间（CI）：3 - 5天/周），平衡训练为3天（95%CI：2 - 4天/周），柔韧性训练为3天（95%CI：3 - 4天/周）。维生素D摄入的依从性为82%（95%CI：73 - 92%），药物审查咨询完成率为86%（95%CI：68 - 95%）。这些结果达到了可行性成功的目标值。术后6个月时牛津膝关节评分为8.78（95%CI：0.40 - 17.16），显示治疗组之间存在具有临床意义且在统计学上有显著差异。术后体弱和生活质量也有临床相关变化的迹象。
本试验为可行性提供了有力证据，并表明术后临床结局有所改善。确定了实施和依从性方面的挑战，可为未来试验的研究设计改进提供参考。
ClinicalTrials.gov NCT02885337。于2016年8月31日注册。https://classic.
gov/ct2/show/NCT02885337。
