FitJoints Program for Hip and Knee Osteoarthritis

Recruiting at3 trial locations

Overseen by Alexandra Papaioannou

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McMaster University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Alexandra Papaioannou

Principal Investigator

McMaster University

Eligibility Criteria

The FitJoints trial is for individuals aged 60 or older who are waiting for hip or knee replacement surgery due to osteoarthritis and have a frailty score of 1-5. They must be facing a wait time of 4 to 15 months for the surgery. Those with inflammatory arthritis, active cancer, renal disorders, current participation in an exercise program or another protein supplement trial, neuromuscular disorders, or language barriers without caregiver support cannot join.

Inclusion Criteria

My surgery is scheduled between 4 to 15 months from now.

I am 60 years old or older.

I am scheduled for a hip or knee replacement surgery.

Exclusion Criteria

I have inflammatory arthritis.

I have a neuromuscular disorder.

Unable to speak or understand English and has no caregiver for translation

Treatment Details

Interventions

• FitJoints Multi-modal Intervention (Behavioural Intervention)

Trial Overview This study tests a multimodal intervention called FitJoints designed to reduce frailty before joint replacement surgery. It includes physiotherapist-led exercises, dietary counseling for better nutrition and protein intake, and medication review. Participants will either receive this intervention for 3-6 months or usual care until their operation date.

Participant Groups

Group I: FitJoints Multi-modal Intervention Active Control 1 Intervention

Group II: Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Evan Stein

McMaster University

Chief Medical Officer since 2015

MD, PhD

Sam

McMaster University

Chief Executive Officer since 2023

MBA from McMaster University

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Dr. Craig A. VanHelder

Hamilton Health Sciences Corporation

Chief Medical Officer since 2023

MD

Tracey MacArthur

Hamilton Health Sciences Corporation

Chief Executive Officer

MSc in Quality Improvement & Patient Safety from the University of Toronto, Honours BA in Psychology from the University of Waterloo, Masters Certificate in Project Management from the Schulich School of Business at York University

St. Joseph's Health Care London

Collaborator

Trials

28

Recruited

2,500+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

Dr. Alex Barron

London Health Sciences Centre

Chief Medical Officer since 2023

MD from Western University

David Musyj

London Health Sciences Centre

Chief Executive Officer

Bachelor of Laws (LLB) from the University of Windsor

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Dr. Verna Yiu

Alberta Health services

Chief Medical Officer

MD

Andre Tremblay

Alberta Health services

Chief Executive Officer

Bachelor's degree in a relevant field