FitJoints: Getting Fit for Hip and Knee Replacement

McMaster University

Status: Enrolling

Conditions: Hip Osteoarthritis; Knee Osteoarthritis

Treatments: Other: FitJoints Multi-modal Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05100966

3732

Details and patient eligibility

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

Enrollment: 192 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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192 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Participants in the control arm will receive usual care which involves patient education that all participants who are scheduled for hip/knee replacement receive at the arthroplasty centre. This may include recommendations to attend fitness classes or discuss nutrition tips and smoking cessation initiatives with their family doctor or other healthcare provider before surgery.

FitJoints Multi-modal Intervention

Active Comparator group

Treatment:

Other: FitJoints Multi-modal Intervention