FitJoints: Getting Fit for Hip and Knee Replacement
- Conditions
- Hip OsteoarthritisKnee Osteoarthritis
- Interventions
- Other: FitJoints Multi-modal Intervention
- Registration Number
- NCT05100966
- Lead Sponsor
- McMaster University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 192
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FitJoints Multi-modal Intervention FitJoints Multi-modal Intervention -
- Primary Outcome Measures
Name Time Method Between-group Difference in Physical Performance 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 Outcome Measures
Name Time Method Between-group Difference in Physical Activities of Daily Living 3-months post-operative Ability to carry out physical activities of daily living as operationalized by the Older American Resources \& Services (OARS) questionnaire. Higher scores indicate greater ability to perform physical activities of daily living \[range 0-14\].
Between-group difference in Sarcopenia 3-months post-operative Assessed by the SARC-F - Self-reported strength, assistance with walking, rising from a chair, climbing stairs and falls. Higher scores indicate greater level of sarcopenia, with scores equal to or greater than 4 predictive of sarcopenia and poorer outcomes \[range 0-10\].
Between-group Difference in Nutrition 3-months post-operative Assessed by the Mini Nutritional Assessment (MNA). Higher scores indicate better nutritional status (\<17 malnourished, 17-23.5 at risk of malnutrition, 24-30 normal nutritional status) \[range 0-30\].
Between-group Difference in Frailty 3-months post-operative Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty \[range 0-1\].
Between-group Difference in Cognition 3-months post-operative Ottawa-3DY-cognitive assessment - recall of day of week, date, year, spell WORLD backwards. Score of 4 indicates normal mental status, \<4 indicates impaired mental status \[range 0-4\].
Between-group Difference in Number of Post-operative Complications 3-months post-operative Any post-op complications (e.g. number of infections, peri-prosthetic fractures, bleeding) will be recorded.
Between-group Difference in Knee Function/Pain 3-months post-operative Patient-reported knee function/pain, assessed by the Oxford Knee Score. Higher scores indicate better knee functionality \[range 0-48\].
Between-group Difference in Hip Function/Pain 3-months post-operative Patient-reported hip function/pain, assessed by the Oxford Hip Score. Higher scores indicate better hip functionality \[range 0-48\].
Between-Group Difference in Instrumental Activities of Daily Living 3-months post-operative Ability to carry out instrumental activities of daily living as operationalized by the Older American Resources \& Services (OARS) questionnaire. Higher scores indicate greater ability to perform instrumental activities of daily living \[range 0-14\].
Between-group Difference in Health-Related Quality of Life 3-months post-operative Quality of life questionnaire (EQ-5D-5L) which consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).Between-group Difference in Number of Hospitalizations 3-months post-operative Number of hospitalizations will be recorded. Higher numbers of hospitalizations indicates higher healthcare utilization.
Between-group Difference in Number of Visits to Physicians/Healthcare Professionals 3-months post-operative Number of visits to physicians and other healthcare professionals will be recorded. Higher number of visits indicates higher healthcare utilization.
Between-group Difference in Number of Emergency Department Visits 3-months post-operative Number of emergency department visits will be recorded. Higher number of emergency department visits indicates higher healthcare utilization.
Trial Locations
- Locations (4)
Foothill Medical Centre - Alberta Health Services
🇨🇦Calgary, Alberta, Canada
Juravinski Hospital - Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
University Hospital - London Health Sciences Centre
🇨🇦London, Ontario, Canada
St. Joseph's Healthcare
🇨🇦Hamilton, Ontario, Canada