Clinical trial NCT04325334: Osteoarthritis Running & Cartilage Assessment
Official title: Linking Biomechanical and Imaging Outcomes to Better Understand the Effects of Running on Knee Joint Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
knee
running
magnetic resonance imaging
MRI
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Both runners with and without knee osteoarthritis will be recruited. They will all receive the same intervention.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilage
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in T2 relaxation time of the medial tibial cartilage
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in T2 relaxation time of the lateral femoral cartilage
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in T2 relaxation time of the lateral tibial cartilage
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilage
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in T1ρ relaxation time of the medial tibial cartilage
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral femoral cartilage
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral tibial cartilage
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in knee joint loading: peak knee adduction moment
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in knee joint loading: knee adduction moment impulse
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in knee joint loading: peak flexion moment
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in knee joint loading: flexion moment impulse
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in knee joint kinematics: peak knee flexion angle
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in knee joint kinematics: knee joint angle excursion
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in foot strike pattern
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in step rate
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in knee symptoms: Knee Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, 12 weeks
measure: Change from Baseline to 12 weeks in knee symptoms: Visual Analog Scale
timeFrame: Baseline to 12 weeks, averaged weekly
measure: Change from Baseline to 12 weeks in weekly running distance
timeFrame: Baseline to 12 weeks, averaged weekly
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Motion Analysis and Biofeedback Laboratory, The University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Michael A Hunt, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: