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OpenTrials
Completed

NCT Number: NCT04325334

Osteoarthritis Running & Cartilage Assessment

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Motion Analysis and Biofeedback Laboratory, The University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Running volume increase

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Acronym: ORCA

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2020
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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