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Increased Running for Knee Osteoarthritis (ORCA Trial)

N/A
Recruiting
Led By Michael A Hunt, PT, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Control Group: free of any radiographic signs of TFOA according to the Kellgren and Lawrence scale (grade = 0)
Control Group: pain free in both knees for the 12 months prior to recruitment
Must not have
ALL: any history of traumatic knee injury (fracture, severe sprain, meniscus injury)
ALL: presence of an inflammatory arthritic condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether running is safe for people with knee osteoarthritis.

Who is the study for?
This trial is for recreational runners over 40 with mild or moderate knee osteoarthritis, experiencing regular knee pain. It's also open to similar-aged runners without knee issues. Participants must have been running regularly for at least a year and be able to run on a treadmill for 30 minutes.
What is being tested?
The study investigates the safety of increasing running volume in individuals with knee osteoarthritis compared to those without it. The impact on joint health will be monitored, filling a research gap regarding exercise as treatment for this condition.
What are the potential side effects?
Since the intervention involves physical activity (running), potential side effects may include increased joint pain, muscle soreness, or exacerbation of existing osteoarthritis symptoms due to higher exercise intensity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My X-rays show no signs of advanced arthritis.
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I have had no knee pain in either knee for the last 12 months.
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My knee X-ray shows I have mild or moderate arthritis.
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I am over 40 years old.
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I have experienced knee pain most days in the last 3 months, especially when running or doing daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a serious knee injury in the past.
Select...
I have an inflammatory arthritis condition.
Select...
I have had surgery on at least one of my knees.
Select...
I have a health condition that stops me from doing activities like running.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline to 12 weeks in T2 relaxation time of the lateral femoral cartilage
Change from Baseline to 12 weeks in T2 relaxation time of the lateral tibial cartilage
Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilage
+1 more
Secondary study objectives
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral femoral cartilage
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral tibial cartilage
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilage
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Running volume increaseExperimental Treatment1 Intervention
Participants will be be given a running program based on their running mileage on inclusion and supported by regular contacts with the study trainer.

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,376 Total Patients Enrolled
26 Trials studying Osteoarthritis
1,898 Patients Enrolled for Osteoarthritis
Michael A Hunt, PT, PhDPrincipal InvestigatorUniversity of British Columbia
3 Previous Clinical Trials
137 Total Patients Enrolled
3 Trials studying Osteoarthritis
137 Patients Enrolled for Osteoarthritis

Media Library

Running volume increase Clinical Trial Eligibility Overview. Trial Name: NCT04325334 — N/A
Osteoarthritis Research Study Groups: Running volume increase
Osteoarthritis Clinical Trial 2023: Running volume increase Highlights & Side Effects. Trial Name: NCT04325334 — N/A
Running volume increase 2023 Treatment Timeline for Medical Study. Trial Name: NCT04325334 — N/A
~0 spots leftby Dec 2024
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