FitJoints Program for Hip and Knee Osteoarthritis

Recruiting at 3 trial locations

Overseen By George Ioannidis, MSc, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Renal disorder, Neuromuscular disorder, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with osteoarthritis who are awaiting hip or knee replacement surgery by reducing their frailty, a condition of physical weakness and increased vulnerability to health issues. It evaluates whether the FitJoints Multi-modal Intervention—a program featuring exercise, nutrition counseling, and medication review—can enhance recovery after surgery. Participants will either engage in this specialized program or continue with usual care, which includes general health advice. Suitable candidates for this trial are individuals aged 60 or older who are frail and awaiting hip or knee replacement surgery. As an unphased trial, this study provides a unique opportunity to potentially enhance recovery and improve quality of life before surgery.

Will I have to stop taking my current medications?

The trial includes a medication review with prescribing recommendations, but it doesn't specify if you must stop your current medications. It's best to discuss your specific situation with the trial team.

What prior data suggests that the FitJoints multimodal frailty intervention is safe?

Research shows that the FitJoints program is safe and well-tolerated by patients. Previous studies indicate it aids recovery after surgery. The program includes exercise, nutrition advice, and a medication review to prepare patients for joint replacement surgery. Participants in earlier trials reported no major side effects. By building strength and improving health before surgery, the program may reduce pain and weakness. This approach aligns with international guidelines on reducing frailty, defined as weakness and vulnerability due to age or illness. Overall, existing research considers the FitJoints program safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FitJoints Multi-modal Intervention for hip and knee osteoarthritis because it goes beyond typical treatments like pain relievers and physical therapy. This program combines a variety of approaches, potentially offering a more comprehensive solution by integrating physical activity, patient education, and lifestyle modifications. Unlike standard care, which often focuses on individual aspects of treatment, FitJoints aims to address multiple factors of osteoarthritis management simultaneously, possibly leading to better outcomes for patients.

What evidence suggests that the FitJoints multimodal frailty intervention is effective for improving post-operative outcomes in hip and knee osteoarthritis patients?

Research has shown that the FitJoints program, which participants in this trial may receive, might benefit those undergoing hip or knee replacement surgery. Previous participants reported feeling stronger, experiencing less pain, and enjoying a better quality of life. The program includes exercise, advice on healthy eating, and a review of medications. Together, these steps aim to enhance recovery after surgery. Early results suggest this approach can improve recovery, making it a promising choice for those preparing for joint replacement. ^{2 3 4 5 6}

Who Is on the Research Team?

Alexandra Papaioannou

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multimodal Intervention

Participants undergo a multimodal frailty reduction intervention including exercise, nutrition, and medication optimization for 3 to 6 months before surgery

3-6 months

In-person or virtual visits as needed

Surgery

Participants undergo hip or knee joint replacement surgery

Follow-up

Participants are monitored for safety and effectiveness after surgery, with assessments of physical performance, nutrition, and quality of life

3 months

What Are the Treatments Tested in This Trial?

Interventions

• FitJoints Multi-modal 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.

How Is the Trial Designed?

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+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

St. Joseph's Health Care London

Collaborator

Trials

28

Recruited

2,500+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2260134125000192

Getting fit for hip and knee replacement: The Fit-Joints ... This trial provides strong evidence of feasibility and indications of improvements in postoperative clinical outcomes.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40042971/

Getting fit for hip and knee replacement: The Fit-Joints ... This trial provides strong evidence of feasibility and indications of improvements in postoperative clinical outcomes.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05100966

FitJoints: Getting Fit for Hip and Knee Replacement To utilize the FitJoints multimodal frailty intervention to build resilience of patients undergoing joint replacement surgery to improve post-operative outcomes ...

4. trialx.com trialx.com/clinical-trials/listings/237588/fitjoints-getting-fit-for-hip-and-knee-replacement/

FitJoints: Getting Fit for Hip and Knee Replacement The proposed study is the first multi-site randomized controlled trial (RCT) to examine whether a multimodal frailty reduction intervention ...

5. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-018-0316-2

Getting fit for hip and knee replacement: a protocol for the Fit ... This is the first study to examine the feasibility of multi-modal frailty intervention in pre-frail/frail older adults undergoing hip or knee replacement.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6053795/

Getting fit for hip and knee replacement: a protocol for the ... Fit Joints study is a pilot parallel group RCT comparing a 3–10 months, pre-operative multi-modal frailty intervention, and usual care among pre ...