Getting Fit for Hip and Knee Replacement: The FitJoints Multisite Randomized Controlled Trial of a Multi-modal Intervention in Frail Patients With Osteoarthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Osteoarthritis
- Sponsor
- McMaster University
- Enrollment
- 192
- Locations
- 4
- Primary Endpoint
- Between-group Difference in Physical Performance
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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:
- Physiotherapist supported multi-component exercise program
- Nutrition and protein optimization including dietary counseling
- Medication review with prescribing recommendations
Investigators
Alexandra Papaioannou
Professor, Department of Medicine
McMaster University
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
Outcomes
Primary Outcomes
Between-group Difference in Physical Performance
Time Frame: 3-months post-operative
Assessed by the Short Physical Performance Battery (SPPB), which consists of the following sub-components: * 4-meter walk test (walking speed): measured in seconds, scored 0 to 4 * Chair rise: the ability to rise from a chair without arms: measured in seconds, scored 0 to 4 * Standing balance test: measured in seconds, scored 0 to 4 Sub-component scores will be aggregated to produce an overall SPPB score, with higher scores indicating lower level of frailty \[range 0-12\].
Secondary Outcomes
- Between-group Difference in Physical Activities of Daily Living(3-months post-operative)
- Between-group difference in Sarcopenia(3-months post-operative)
- Between-group Difference in Nutrition(3-months post-operative)
- Between-group Difference in Frailty(3-months post-operative)
- Between-group Difference in Cognition(3-months post-operative)
- Between-group Difference in Number of Post-operative Complications(3-months post-operative)
- Between-group Difference in Knee Function/Pain(3-months post-operative)
- Between-group Difference in Hip Function/Pain(3-months post-operative)
- Between-Group Difference in Instrumental Activities of Daily Living(3-months post-operative)
- Between-group Difference in Health-Related Quality of Life(3-months post-operative)
- Between-group Difference in Number of Hospitalizations(3-months post-operative)
- Between-group Difference in Number of Visits to Physicians/Healthcare Professionals(3-months post-operative)
- Between-group Difference in Number of Emergency Department Visits(3-months post-operative)