FitJoints: Getting Fit for Hip and Knee Replacement

Официальное название

Getting Fit for Hip and Knee Replacement: The FitJoints Multisite Randomized Controlled Trial of a Multi-modal Intervention in Frail Patients With Osteoarthritis

Обзор

Total hip or knee replacement is an important and cost-effective surgical intervention to relieve pain and improve independence and function in patients with osteoarthritis. The number of people waiting for elective surgeries has spiked in the COVID-19 pandemic. Prior to COVID-19, up to 40% of patients receiving joint replacement were frail and this number is rapidly increasing with longer wait-times and deconditioning associated with COVID-19 physical distancing. There is an urgent need to be responsive to the evolving challenges of healthcare. The proposed study is the first multi-site randomized controlled trial (RCT) to examine whether a multimodal frailty reduction intervention before surgery will improve postsurgical outcomes for this population. The COVID-19 adapted hybrid model includes a multimodal frailty intervention that may be implemented either in person or virtually and is aligned with international consensus guidelines on frailty reduction. To utilize the FitJoints multimodal frailty intervention to build resilience of patients undergoing joint replacement surgery to improve post-operative outcomes. The investigators hypothesize the FitJoints multimodal frailty intervention, with exercise, nutrition and medication optimization, will reduce frailty and pain while improving function and quality of life. Building upon the success of the FitJoints feasibility study (n=69) in Hamilton, Ontario, in the proposed multi-site RCT (n=192), older adults (≥60 years) undergoing hip or knee joint replacement surgery who are frail will be randomized to either the 3 to 6-months of multimodal intervention or usual care until the date of their surgery at multiple sites (Hamilton Health Sciences \& St Joseph's Healthcare Hamilton, ON; London Health Science Centre, London, ON; Foothills Hospital, Calgary, AB),The FitJoints evidence-based, multimodal intervention includes a hybrid model that can be implemented either in person or virtually: 1. Physiotherapist supported multi-component exercise program 2. Nutrition and protein optimization including dietary counseling 3. Medication review with prescribing recommendations

Вмешательства

• Другое FitJoints Multi-modal Intervention
  Exercise: The study physiotherapist will prescribe an exercise program tailored to the participant's individual ability and preference with functional movements to mimic activities of daily living. Nutritional consultation and protein supplement: The site research assistant will coach participants to improve their nutrition, determine their daily protein target, and provide educational tools on how to achieve their target. Protein supplements will be provided to participants. Vitamin D: Partic

Первичные конечные точки

• Between-group Difference in Physical Performance [Срок оценки: 3-months post-operative]

Вторичные конечные точки (12)

• Between-group Difference in Frailty [Срок оценки: 3-months post-operative]
• Between-group Difference in Knee Function/Pain [Срок оценки: 3-months post-operative]
• Between-group Difference in Hip Function/Pain [Срок оценки: 3-months post-operative]
• Between-Group Difference in Instrumental Activities of Daily Living [Срок оценки: 3-months post-operative]
• Between-group Difference in Physical Activities of Daily Living [Срок оценки: 3-months post-operative]
• Between-group difference in Sarcopenia [Срок оценки: 3-months post-operative]
• Between-group Difference in Nutrition [Срок оценки: 3-months post-operative]
• Between-group Difference in Cognition [Срок оценки: 3-months post-operative]
• Between-group Difference in Health-Related Quality of Life [Срок оценки: 3-months post-operative]
• Between-group Difference in Number of Hospitalizations [Срок оценки: 3-months post-operative]
• Between-group Difference in Number of Emergency Department Visits [Срок оценки: 3-months post-operative]
• Between-group Difference in Number of Visits to Physicians/Healthcare Professionals [Срок оценки: 3-months post-operative]

Критерии участия

Критерии включения

• Pre-frail (score of 1 or 2) or frail (score of 3-5)
• ≥ 60 years old
• Receiving elective unilateral total hip or knee replacement
• Waiting time for surgery is estimated to be between 4 to 15 months

Критерии исключения

• Renal disorder
• A neuromuscular disorder
• Active cancer
• Inflammatory arthritis
• Unable to speak or understand English and has no caregiver for translation
• Participating in another trial that involves protein supplementation
• Participating in an exercise program

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

Двойное слепое

Основная цель

Профилактика

Центры проведения

Канада · 4 центра

• Foothill Medical Centre - Alberta Health Services — Calgary
• Juravinski Hospital - Hamilton Health Sciences — Hamilton
• St. Joseph's Healthcare — Hamilton
• University Hospital - London Health Sciences Centre — London

Идентификаторы

NCT: NCT05100966 · 3732

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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