Multimodal Prehabilitation of Frail Patients 70 Years and Older Undergoing Elective Knee or Hip Replacement: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Recruitment rate
研究概览
简要总结
Background: Frailty is a geriatric syndrome of reduced physiologic reserve that increases surgical risk and is common among older adults undergoing hip or knee replacement. While prehabilitation has shown promise in enhancing outcomes, evidence from randomized controlled trials (RCTs) in frail orthopedic patients is limited.
Objective: This study aims to evaluate the feasibility and preliminary data on the effectiveness of a multimodal prehabilitation program for frail patients undergoing elective hip or knee arthroplasty.
Methods: A pilot RCT will be conducted at Landspítali-University Hospital. Patients ≥70 years scheduled for surgery with ≥2 months waiting time will be screened for frailty using PRISMA-7, the Clock Drawing Test, and Timed Up & Go. Patients screening positive for any of the three screening tools will be randomized to multimodal prehabilitation or standard of care. The intervention includes comprehensive geriatric assessment, medication review, tailored physiotherapy using the Otago Exercise Programme, and nutritional counseling if at risk of malnutrition. We will conduct an external pilot for feasibility measures (overall enrollment, recruitment, retention, adherence). Secondary outcomes include physical performance, postoperative complications, patient-reported health status (WOMAC scale) and quality of life (EQ-5D-3L ), length of primary hospital stay, discharge location, falls postoperatively, 180-day readmission and 180-day mortality.
Significance: This trial may aid in the design of larger RCT study and provide a signal of the role of multimodal prehabilitation on outcomes, including quality of life and health status among frail arthroplasty patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 70 years or older assigned to undergo hip/knee replacement at Landspítali University Hospital.
- •Inclusion will be offered to patients who have previously presented at the outpatient orthopedic department and been scheduled for an elective (with a waiting period ≥2 months before surgery) hip/knee replacement.
- •Patients who are willing to participate and sign informed consent and are willing to be randomized to the control or intervention arm.
排除标准
- •Patients who screen negative for all frailty tools will be excluded from the study.
- •Patients who are already in active physiotherapy, meeting with a physiotherapist >1 every month, will also be excluded.
- •In addition, those who do not undergo planned surgery, are undergoing redo hip/knee prosthesis replacement will be excluded
研究组 & 干预措施
Prehabilitation group
This arm will undergo the intervention (multimodal prehabilitation).
干预措施: Multimodal Prehabilitation (Other)
Control group
This arm will be the control group and will not undergo the intervention (prehabilitation). The standard of care for patients undergoing elective prosthesis surgery who present at the perioperative services prior to surgery includes a preoperative appointment with a physiotherapist to guide postoperative recovery and the use of assistive devices, a consultation with a nurse to review preoperative hygiene measures such as showering, and a telephone consultation with an anesthetist for preoperative evaluation, risk assessment, and review of routine laboratory tests (e.g., blood work). As part of this process, medications, including blood thinners and anticoagulants, are adjusted as needed. In addition, patients receive education regarding perioperative management and anesthesia, with further work-up performed on an as-needed basis. Usually, patients present within 1-4 weeks before surgery.
结局指标
主要结局
Recruitment rate
时间窗: During the inclusion time period, from enrollment of the first patient to the enrollment of the last patient or up to one year from the start of the study.
Out of all the patients screened the recruitment will be defined the proportion of patients who were randomized
Retention rate
时间窗: The study period, from the randomization to 180-day follow-up
Out of all the patients randomized, the proportion of patients who complete follow-up
Overall enrollment yield
时间窗: During the inclusion time period, from enrollment of the first patient to the enrollment of the last patient or up to one year from the start of the study.
Proportion of all patients invited for frailty screening (≥70 years and scheduled for arthroplasty) who are ultimately randomised into the trial.
Exercise adherence
时间窗: Throughout the prehabilitation period, which is from enrollment to surgery (2-8 months)
Adherence to exercise prehabilitation, defined as completing ≥80% of the prescribed sessions or tasks.
次要结局
- - Preoperative optimization(From enrollment until surgery (approximately 2-8 months))
- Change in health status (joint pain and function)(Before prehabilitation and 3-6 months after surgery.)
- Change in quality of life(Before prehabilitation and 3-6 months after surgery.)
- Nutritional adherence(Throughout the prehabilitation period from enrollment until surgery (2-8 months).)
- Four-stage balance test(At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).)
- 30-second chair stand test(At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).)
- Timed Up and Go test (TUG)(At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).)
研究者
Martin Ingi Sigurdsson
Professor in Anesthesiology and Intensive Care
University of Iceland