Clinical trial NCT05100966: FitJoints: Getting Fit for Hip and Knee Replacement
Official title: Getting Fit for Hip and Knee Replacement: The FitJoints Multisite Randomized Controlled Trial of a Multi-modal Intervention in Frail Patients With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Keywords: Frail elderly
Arthroplasty
Pre-rehabilitation
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
name: St. Joseph's Health Care London
name: London Health Sciences Centre
name: Alberta Health services
First posted: 2021-10-29
Enrollment: 192
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Primary outcomes:
measure: Between-group Difference in Physical Performance
timeFrame: 3-months post-operative
Secondary outcomes:
measure: Between-group Difference in Frailty
timeFrame: 3-months post-operative
measure: Between-group Difference in Knee Function/Pain
timeFrame: 3-months post-operative
measure: Between-group Difference in Hip Function/Pain
timeFrame: 3-months post-operative
measure: Between-Group Difference in Instrumental Activities of Daily Living
timeFrame: 3-months post-operative
measure: Between-group Difference in Physical Activities of Daily Living
timeFrame: 3-months post-operative
measure: Between-group difference in Sarcopenia
timeFrame: 3-months post-operative
measure: Between-group Difference in Nutrition
timeFrame: 3-months post-operative
measure: Between-group Difference in Cognition
timeFrame: 3-months post-operative
measure: Between-group Difference in Health-Related Quality of Life
timeFrame: 3-months post-operative
measure: Between-group Difference in Number of Hospitalizations
timeFrame: 3-months post-operative
measure: Between-group Difference in Number of Emergency Department Visits
timeFrame: 3-months post-operative
measure: Between-group Difference in Number of Visits to Physicians/Healthcare Professionals
timeFrame: 3-months post-operative
measure: Between-group Difference in Number of Post-operative Complications
timeFrame: 3-months post-operative
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothill Medical Centre - Alberta Health Services
state: Alberta
city: Hamilton
country: Canada
facility: Juravinski Hospital - Hamilton Health Sciences
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: London
country: Canada
facility: University Hospital - London Health Sciences Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Alexandra Papaioannou
role: PRINCIPAL_INVESTIGATOR
References: