The GORUN Study: Gradual Onset of RUNning and Knee Joint Health in Novice Runners
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- T2 relaxation time - medial tibia
研究概览
简要总结
Knee osteoarthritis (OA) is a debilitating disease affecting millions worldwide. Exercise is a core treatment for knee OA, and is advocated by all clinical guidelines. Running is a common exercise that is accessible and evokes a number of positive physical and psychological benefits. However, the appropriateness of recreational running in the presence of knee OA is unclear.
A growing literature base appears to suggest that running may not be deleterious to the health - especially at the knee joint - of people with knee OA. Our recent research has focused on examining a number of health outcomes relevant to knee OA in older individuals with knee OA, but has been limited to experienced runners. This study will address that limitation by focusing on how novice (new) runners respond to a new running program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •have been running consistently for no more than six months at time of enrolment, with a cumulative weekly volume of less than 5 kilometres OR have yet to take up recreational running consistently
- •are comfortable running and walking on a treadmill for at least 30 minutes
- •Inclusion criteria (knee osteoarthritis (OA) group):
- •have definitive knee OA as diagnosed using x-rays
- •report having experienced frequent knee pain over the past 3 months
- •Inclusion criteria (Control group):
- •have no evidence of knee OA based on x-rays
- •have had pain-free knees for at least the past 3 months
排除标准
- •have an inflammatory arthritic condition (e.g. gout or rheumatoid arthritis)
- •have a presence of any health condition (other than OA in the knee OA group) affecting normal movement or that precludes engaging in moderate to high impact activities such as running
- •Additionally, exclusion criteria based on MRI safety:
- •cannot safely fit into the MRI scanner
- •presence of metallic implants (including pace makers, brain aneurysm clips, stents, cochlear implants, artificial heart valves, and prostheses)
- •recent surgery or tattoos within the past 6 weeks
- •current or possible pregnancy
- •electrical stimulator for nerves or bones
- •infusion pumps
- •shrapnel or other metallic fragments
- •non-removable metallic jewellry
研究组 & 干预措施
Healthy control
Pain-free Individuals without radiographic evidence of knee osteoarthritis who will receive the running program intervention
干预措施: Running volume increase (Behavioral)
Knee osteoarthritis group
Individuals with knee pain and radiographic evidence of knee osteoarthritis who will receive the running program intervention
干预措施: Running volume increase (Behavioral)
结局指标
主要结局
T2 relaxation time - medial tibia
时间窗: Baseline and 6 months
Magnetic resonance imaging (MRI) of the knee cartilage will be used to measure the exponential decay/dephasing of transverse magnetization of protons, known as T2 relaxation time (measured in milliseconds). Cartilage will be segmented into a number of regions of interest, with relaxation times calculated separately for each region of interest.
T2 relaxation time - medial femur
时间窗: Baseline and 6 months
Magnetic resonance imaging (MRI) of the knee cartilage will be used to measure the exponential decay/dephasing of transverse magnetization of protons, known as T2 relaxation time (measured in milliseconds). Cartilage will be segmented into a number of regions of interest, with relaxation times calculated separately for each region of interest.
T2 relaxation time - patella
时间窗: Baseline and 6 months
Magnetic resonance imaging (MRI) of the knee cartilage will be used to measure the exponential decay/dephasing of transverse magnetization of protons, known as T2 relaxation time (measured in milliseconds). Cartilage will be segmented into a number of regions of interest, with relaxation times calculated separately for each region of interest.
次要结局
- T1rho relaxation time - medial tibia(Baseline and 6 months)
- T1rho relaxation time - medial femur(Baseline and 6 months)
- T1rho relaxation time - patella(Baseline and 6 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) - pain subscale(Baseline and 6 months)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) - function in daily living subscale(Baseline and 6 months)
研究者
Michael Hunt
Professor
University of British Columbia