NCT05100966 FitJoints: Getting Fit for Hip and Knee Replacement
| NCT ID | NCT05100966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McMaster University |
| Condition | Hip Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2022-06-14 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2022-06-14 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Alexandra Papaioannou
PRINCIPAL INVESTIGATOR
McMaster University
Frequently Asked Questions
Who can join the NCT05100966 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Hip Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05100966 currently recruiting?
Yes, NCT05100966 is actively recruiting participants. Contact the research team at papaioannou@hhsc.ca for enrollment information.
Where is the NCT05100966 trial being conducted?
This trial is being conducted at Calgary, Canada, Hamilton, Canada, Hamilton, Canada, London, Canada.
Who is sponsoring the NCT05100966 clinical trial?
NCT05100966 is sponsored by McMaster University. The principal investigator is Alexandra Papaioannou at McMaster University. The trial plans to enroll 192 participants.