Linking Biomechanical and Imaging Outcomes to Better Understand the Effects of Running on Knee Joint Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilage
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change from Baseline to 12 weeks in T2 relaxation time of the medial femoral cartilage
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral femoral cartilage(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in T1ρ relaxation time of the medial femoral cartilage(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in knee joint loading: flexion moment impulse(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in weekly running distance(Baseline to 12 weeks, averaged weekly)
- Change from Baseline to 12 weeks in T1ρ relaxation time of the medial tibial cartilage(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in T1ρ relaxation time of the lateral tibial cartilage(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in knee joint loading: peak flexion moment(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in knee joint kinematics: peak knee flexion angle(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in knee joint kinematics: knee joint angle excursion(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in knee joint loading: peak knee adduction moment(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in foot strike pattern(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in knee joint loading: knee adduction moment impulse(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in knee symptoms: Knee Osteoarthritis Outcome Score (KOOS)(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in step rate(Baseline, 12 weeks)
- Change from Baseline to 12 weeks in knee symptoms: Visual Analog Scale(Baseline to 12 weeks, averaged weekly)
研究者
Michael Hunt
Associate Professor
University of British Columbia