Multimodal Prehabilitation of Frail Patients Undergoing Elective Knee or Hip Replacement

Официальное название

Multimodal Prehabilitation of Frail Patients 70 Years and Older Undergoing Elective Knee or Hip Replacement: A Pilot Randomized Controlled Trial

Обзор

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-5L ), 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.

Вмешательства

• Другое Multimodal Prehabilitation
  The intervention will begin ≥2 months before planned surgery and consists of a multimodal prehabilitation program. Participants will undergo geriatric assessment with frailty evaluation, medication review, and optimization of comorbidities as needed. Patients at risk of malnutrition will receive nutritional assessment, counseling, and supplementation when indicated. All participants will receive individualized physiotherapy based on the Otago Exercise Programme, including strength, balance, and

Первичные конечные точки

• Recruitment rate [Срок оценки: 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.]
• Retention rate [Срок оценки: The study period, from the randomization to 180-day follow-up]
• Overall enrollment yield [Срок оценки: 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.]
• Exercise adherence [Срок оценки: Throughout the prehabilitation period, which is from enrollment to surgery (2-8 months)]

Вторичные конечные точки (7)

• - Preoperative optimization [Срок оценки: From enrollment until surgery (approximately 2-8 months)]
• Change in health status (joint pain and function) [Срок оценки: Before prehabilitation and 3-6 months after surgery.]
• Change in quality of life [Срок оценки: Before prehabilitation and 3-6 months after surgery.]
• Nutritional adherence [Срок оценки: Throughout the prehabilitation period from enrollment until surgery (2-8 months).]
• Four-stage balance test [Срок оценки: At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).]
• 30-second chair stand test [Срок оценки: At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).]
• Timed Up and Go test (TUG) [Срок оценки: At baseline (enrollment) and at the end of the prehabilitation period before surgery (2-8 months).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Iceland · 1 центр

• Landspitali University hospital — Reykjavik

Идентификаторы

NCT: NCT07465159 · VSN2512023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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