NCT04542668已完成不适用
An Open-label, Randomized, Cross-over Study to Investigate the Effect of Weight-bearing vs Non-weight-bearing Exercise and Cardiovascular Stress Without Load on Collagen and Proteoglycan in Serum and Urine in Patients With Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Acute chances in biomarkers
研究概览
简要总结
The aim of EFEX-OA-02 is to explore how running, cycling, exercise simulation and resting acutely influence collagen and proteoglycan homeostasis in OA, as reflected by changes in collagen and proteoglycan levels in urine and serum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cumulated Osteoarthritis Kellgren-Lawrence radiological grade of at least 2 in the tibio-femoral joints diagnosed by screening X-ray.
- •40 to < 75 years of age at time of signing the informed consent.
- •Body weight > 50 and < 100 kg and BMI in the range 18.5-35 kg/m2 .
- •Male or female.
- •Able to attend all four study sessions and comply with the dietary and activity restrictions.
- •Able to provide informed consent
排除标准
- •Medical conditions:
- •Osteoarthritis Kellgren-Lawrence radiological grade of 4 in one or both knees.
- •Cumulated osteoarthritis Kellgren-Lawrence radiological grade no higher than
- •History of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening.
- •Previous arthroplasty of knee or hip.
- •Intention to have major surgery during the timeframe of the study.
- •Secondary OA related to e.g. any known trauma including cruciate ligament tears, meniscus tears and cartilage damage, dysplasia, aseptic osteonecrosis, acromegaly, Paget disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis (pseudogout).
- •Current treatment with beta-receptor adrenergic antagonists (beta-blockers), MAO inhibitor, systemic corticosteroid treatment in doses equivalent to > 10 mg prednisolone per day, or vitamin K antagonists, new oral anticoagulants, fractionated and non-fractionated heparin.
- •Active systemic infection.
- •Active systemic inflammatory or autoimmune disease.
- •Any sign of previous or current cardiovascular disease.
- •Not currently an active athlete or highly trained individual.
- •Other exclusion criteria:
- •Legal incapacity or limited legal capacity.
- •Inability to communicate or cooperate with the investigator or to comply with the requirements of the entire study.
- •Categorized as being very difficult to draw blood from, as evaluated by the investigator.
- •Current alcohol abuse and/or inability to refrain from intake of alcoholic beverages for 24 hours prior to the study intervention.
- •Other factors, e.g. self-reported drug abuse, which in the opinion of the investigator may interfere with the performance of the study.
- •Site staff, study staff members and study staff family members.
- •Other concomitant disease compromising or otherwise significantly affecting ECM turnover in the opinion of the investigator.
结局指标
主要结局
Acute chances in biomarkers
时间窗: Acute: 0-4 hours and subacute: 24 hours
Serum and urine biochemical markers of joint related collagens and proteoglycan (not further specified)
次要结局
未报告次要终点
研究者
研究点 (2)
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