Osteoarthritis Running & Cartilage Assessment

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Behavioral: Running volume increase

• Registration Number: NCT04325334
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Running volume increase	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilage	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.
Change from Baseline to 12 weeks in T2 relaxation time of the lateral tibial cartilage	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.
Change from Baseline to 12 weeks in T2 relaxation time of the medial tibial cartilage	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.
Change from Baseline to 12 weeks in T2 relaxation time of the lateral femoral cartilage	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 Outcome Measures

Name	Time	Method
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilage	Baseline, 12 weeks	T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Change from Baseline to 12 weeks in knee joint loading: flexion moment impulse	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.
Change from Baseline to 12 weeks in weekly running distance	Baseline to 12 weeks, averaged weekly	Participants will record their weekly running distance using an online diary.
Change from Baseline to 12 weeks in T1ρ relaxation time of the medial tibial cartilage	Baseline, 12 weeks	T1ρ 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 cartilage	Baseline, 12 weeks	T1ρ 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 cartilage	Baseline, 12 weeks	T1ρ provides an indication of glycosaminoglycan concentration in cartilage assessed using MRI.
Change from Baseline to 12 weeks in knee joint loading: peak flexion moment	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.
Change from Baseline to 12 weeks in knee joint kinematics: peak knee flexion angle	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.
Change from Baseline to 12 weeks in knee joint kinematics: knee joint angle excursion	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.
Change from Baseline to 12 weeks in knee joint loading: peak knee adduction moment	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.
Change from Baseline to 12 weeks in foot strike pattern	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.
Change from Baseline to 12 weeks in knee joint loading: knee adduction moment impulse	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.
Change from Baseline to 12 weeks in knee symptoms: Knee Osteoarthritis Outcome Score (KOOS)	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.
Change from Baseline to 12 weeks in step rate	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.
Change from Baseline to 12 weeks in knee symptoms: Visual Analog Scale	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.

Trial Locations

Locations (1)

Motion Analysis and Biofeedback Laboratory, The University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada