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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks
Awards & highlights

ORCA Trial 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.Check my eligibility
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.See study design
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.

ORCA Trial 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.

ORCA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

ORCA 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
1,415 Previous Clinical Trials
2,466,936 Total Patients Enrolled
26 Trials studying Osteoarthritis
1,887 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this trial being conducted with participants?

"Affirmative. Clinicaltrials.gov has information showing that this medical trial went live as of December 1st 2019, and is actively recruiting participants with the last update occurring on May 16th 2022. The recruitment involves 80 patients from one centre."

Answered by AI

What is the projected outcome of this clinical experiment?

"The primary objective of this trial, which will be monitored over the course of a baseline and 12-week timeframe, is to track changes in T2 relaxation time of the medial tibial cartilage. Secondary objectives include: recording weekly running distances through an online diary; assessing glycosaminoglycan concentration in lateral tibial cartilage with MRI (T1ρ); as well as monitoring for related changes in glycosaminoglycan concentration within the medial femoral cartilage via MRI (T1ρ)."

Answered by AI

Are volunteers currently being recruited for this clinical experiment?

"Affirmative. The information posted on clinicaltrials.gov confirms that this medical study, initially advertised in December 2019, is still recruiting participants. 80 individuals are expected to take part at one site."

Answered by AI
~9 spots leftby Dec 2024