FitJoints: Getting Fit for Hip and Knee Replacement
Recruiting · NCT05100966 · Interventional (participants receive a specific treatment) · Lead sponsor: McMaster University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
4 locations listed.
- Foothill Medical Centre - Alberta Health Services - Calgary, Alberta, Canada
- Juravinski Hospital - Hamilton Health Sciences - Hamilton, Ontario, Canada
- St. Joseph's Healthcare - Hamilton, Ontario, Canada
- University Hospital - London Health Sciences Centre - London, Ontario, Canada