Osteoarthritis Running & Cartilage Assessment (ORCA)

November 27, 2023 updated by: Michael Hunt, University of British Columbia

Linking Biomechanical and Imaging Outcomes to Better Understand the Effects of Running on Knee Joint Health

Knee osteoarthritis (OA) is a debilitating disease affecting millions of Canadians. Exercise is a core treatment for knee OA, and is advocated by all clinical guidelines. However, the safety of recreational running in the presence of knee OA is unclear. There are no studies available to provide direct data to appropriately inform runners and clinicians whether running should be advocated for joint health. Our research study will address this gap.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Recruiting
        • Motion Analysis and Biofeedback Laboratory, The University of British Columbia
        • Contact:
        • Principal Investigator:
          • Michael A Hunt, PT, PhD
        • Sub-Investigator:
          • Jean-Francois Esculier, PT, PhD
        • Sub-Investigator:
          • David R Wilson, DPhil
        • Sub-Investigator:
          • Alexander Rauscher, PhD
        • Sub-Investigator:
          • Jack Taunton, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

ALL:

  • aged greater than 40 years
  • recreational runners who run at least twice per week for a total of at least 10 km, and have done so for a minimum of 12 months
  • comfortable running on a treadmill for 30 minutes.

TFOA Group:

  • exhibit radiographic evidence of mild or moderate tibiofemoral osteoarthritis (TFOA) according to the Kellgren and Lawrence OA classification scale (grade ≥ 2)
  • report knee pain on most days of the previous 3 months (during running and activities of daily living).

Control Group:

  • free of any radiographic signs of TFOA according to the Kellgren and Lawrence scale (grade = 0)
  • pain free in both knees for the 12 months prior to recruitment.

Exclusion Criteria:

ALL:

  • any history of traumatic knee injury (fracture, severe sprain, meniscus injury)
  • presence of an inflammatory arthritic condition
  • presence of any health condition (other than OA in the TFOA group) affecting normal movement or precludes engaging in moderate to high impact activities such as running
  • use of any oral or injected corticosteroids or viscosupplementation in the previous 6 months
  • any history of surgery in either knee
  • standard contra-indications to magnetic resonance imaging (MRI).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Running volume increase
Participants will be be given a running program based on their running mileage on inclusion and supported by regular contacts with the study trainer.
Participants will receive a 12-week running program to increase their running volume by approximately 10% per week on average, and in accordance with the "10% rule" advocated to minimize injury rates. For the purpose of this study, participants will run using their habitual technique - i.e. no specific instructions on 'how' to run will be provided; rather, they will simply be instructed on 'how much' to run.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilage
Time Frame: Baseline, 12 weeks
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
Baseline, 12 weeks
Change from Baseline to 12 weeks in T2 relaxation time of the medial tibial cartilage
Time Frame: Baseline, 12 weeks
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
Baseline, 12 weeks
Change from Baseline to 12 weeks in T2 relaxation time of the lateral femoral cartilage
Time Frame: Baseline, 12 weeks
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
Baseline, 12 weeks
Change from Baseline to 12 weeks in T2 relaxation time of the lateral tibial cartilage
Time Frame: Baseline, 12 weeks
T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. This constant is assessed using MRI.
Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilage
Time Frame: Baseline, 12 weeks
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Baseline, 12 weeks
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial tibial cartilage
Time Frame: Baseline, 12 weeks
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Baseline, 12 weeks
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral femoral cartilage
Time Frame: Baseline, 12 weeks
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Baseline, 12 weeks
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral tibial cartilage
Time Frame: Baseline, 12 weeks
T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: peak knee adduction moment
Time Frame: Baseline, 12 weeks
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: knee adduction moment impulse
Time Frame: Baseline, 12 weeks
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: peak flexion moment
Time Frame: Baseline, 12 weeks
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint loading: flexion moment impulse
Time Frame: Baseline, 12 weeks
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint kinematics: peak knee flexion angle
Time Frame: Baseline, 12 weeks
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Baseline, 12 weeks
Change from Baseline to 12 weeks in knee joint kinematics: knee joint angle excursion
Time Frame: Baseline, 12 weeks
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Baseline, 12 weeks
Change from Baseline to 12 weeks in foot strike pattern
Time Frame: Baseline, 12 weeks
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Baseline, 12 weeks
Change from Baseline to 12 weeks in step rate
Time Frame: Baseline, 12 weeks
Participants will run on an instrumented treadmill in their habitual running shoes while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and treadmill-embedded force platforms.
Baseline, 12 weeks
Change from Baseline to 12 weeks in knee symptoms: Knee Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline, 12 weeks
Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis. The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.
Baseline, 12 weeks
Change from Baseline to 12 weeks in knee symptoms: Visual Analog Scale
Time Frame: Baseline to 12 weeks, averaged weekly
Knee pain during and after running will be assessed for each training. The minimum value is "No Pain" and the maximum value is "Worst Pain Imaginable". Each week of training will be averaged.
Baseline to 12 weeks, averaged weekly
Change from Baseline to 12 weeks in weekly running distance
Time Frame: Baseline to 12 weeks, averaged weekly
Participants will record their weekly running distance using an online diary.
Baseline to 12 weeks, averaged weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael A Hunt, PT, PhD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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