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FitJoints Program for Hip and Knee Osteoarthritis
N/A
Recruiting
Led By Alexandra Papaioannou
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 60 years old
Receiving elective unilateral total hip or knee replacement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-months post-operative
Awards & highlights
Study Summary
This trial will help to improve post-operative outcomes for patients undergoing joint replacement surgery who are frail.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the interventions involve non-invasive activities like exercise programs and nutritional counseling rather than medications or surgeries, side effects may include typical exercise-related issues such as muscle soreness but are generally expected to be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Select...
I am scheduled for a hip or knee replacement surgery.
Select...
I am considered pre-frail or frail based on a specific health score.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-months post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-months post-operative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Between-group Difference in Physical Performance
Secondary outcome measures
Between-Group Difference in Instrumental Activities of Daily Living
Between-group Difference in Cognition
Between-group Difference in Frailty
+10 moreTrial Design
2Treatment groups
Active Control
Group I: FitJoints Multi-modal InterventionActive Control1 Intervention
Group II: Usual CareActive Control1 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.
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Who is running the clinical trial?
McMaster UniversityLead Sponsor
881 Previous Clinical Trials
2,597,694 Total Patients Enrolled
Hamilton Health Sciences CorporationOTHER
368 Previous Clinical Trials
300,809 Total Patients Enrolled
St. Joseph's Health Care LondonOTHER
27 Previous Clinical Trials
2,306 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgery is scheduled between 4 to 15 months from now.I am 60 years old or older.I have inflammatory arthritis.I have a neuromuscular disorder.I am scheduled for a hip or knee replacement surgery.My cancer is currently active.I have a kidney condition.I am currently in a trial that involves taking protein supplements.I am considered pre-frail or frail based on a specific health score.
Research Study Groups:
This trial has the following groups:- Group 1: FitJoints Multi-modal Intervention
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can new participants still join this clinical trial?
"Yes, the trial is recruiting patients and has currently enrolled 192 participants from 4 sites. The data on clinicaltrials.gov shows that the study was first posted on 6/14/2022 and was most recently edited on 7/14/2022."
Answered by AI
How many people have been chosen to participate in this trial?
"That is accurate. As per the information available on clinicaltrials.gov, this research project is looking for 192 participants from 4 different hospitals or clinics. The initial posting was on 6/14/2022, with the most recent update being 7/14/2022."
Answered by AI
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