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Osteoarthritis Running & Cartilage Assessment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04325334
Acronym
ORCA
Enrollment
74
Registered
2020-03-27
Start date
2019-12-01
Completion date
2024-10-04
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis, knee, running, magnetic resonance imaging, MRI

Brief summary

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.

Interventions

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.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Both runners with and without knee osteoarthritis will be recruited. They will all receive the same intervention.

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilageBaseline, 12 weeksT2 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.
Change from Baseline to 12 weeks in T2 relaxation time of the medial tibial cartilageBaseline, 12 weeksT2 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.
Change from Baseline to 12 weeks in T2 relaxation time of the lateral femoral cartilageBaseline, 12 weeksT2 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.
Change from Baseline to 12 weeks in T2 relaxation time of the lateral tibial cartilageBaseline, 12 weeksT2 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

MeasureTime frameDescription
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial tibial cartilageBaseline, 12 weeksT1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral femoral cartilageBaseline, 12 weeksT1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral tibial cartilageBaseline, 12 weeksT1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Change from Baseline to 12 weeks in knee joint loading: peak knee adduction momentBaseline, 12 weeksParticipants 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.
Change from Baseline to 12 weeks in knee joint loading: knee adduction moment impulseBaseline, 12 weeksParticipants 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.
Change from Baseline to 12 weeks in knee symptoms: Knee Osteoarthritis Outcome Score (KOOS)Baseline, 12 weeksValidated 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.
Change from Baseline to 12 weeks in knee joint loading: flexion moment impulseBaseline, 12 weeksParticipants 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.
Change from Baseline to 12 weeks in knee joint kinematics: peak knee flexion angleBaseline, 12 weeksParticipants 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.
Change from Baseline to 12 weeks in knee joint kinematics: knee joint angle excursionBaseline, 12 weeksParticipants 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.
Change from Baseline to 12 weeks in foot strike patternBaseline, 12 weeksParticipants 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.
Change from Baseline to 12 weeks in step rateBaseline, 12 weeksParticipants 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.
Change from Baseline to 12 weeks in knee joint loading: peak flexion momentBaseline, 12 weeksParticipants 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.
Change from Baseline to 12 weeks in knee symptoms: Visual Analog ScaleBaseline to 12 weeks, averaged weeklyKnee 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.
Change from Baseline to 12 weeks in weekly running distanceBaseline to 12 weeks, averaged weeklyParticipants will record their weekly running distance using an online diary.
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilageBaseline, 12 weeksT1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026