NCT04542655已完成不适用
An Open-label, Single-center, Randomized, Controlled, Exploratory Study to Investigate the Effect of Weight Bearing Versus Non-weight Bearing Exercise on Collagen and Proteoglycan in Serum and Urine in Patients With Osteoarthritis and Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in biomarkers (exploratory)
研究概览
简要总结
Aim of EFEX-OA-01: To explore how running, cycling and resting acutely influence levels of collagen and proteoglycan in patients with osteoarthritis knee and in young healthy subjects, as reflected by changes in serum and urine biochemical markers originating from joint related collagens and proteoglycans.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for OA patients:
- •Kellgren-Lawrence radiological grade of 1-3 in at least one tibio-femoral joint diagnosed by screening x-ray.
- •35 to < 75 years of age at the time of signing the informed consent form.
- •Bodyweight > 50 and < 150 kg and a BMI in the range 18,5-35 kg/m
- •Are male or female.
- •Is able to meet for all of the four study visits and comply with the dietary and activity restrictions.
- •Can give informed consent.
排除标准
- •for OA patients:
- •Medical conditions:
- •History of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening.
- •Kellgren-Lawrence radiological grade of 4 in at least one tibio-femoral joint
- •Previous arthroplasty of knee or hip.
- •Intention of having major surgery during the timeframe of this study.
- •OA related to eg. dysplasia, aseptic osteonecrosis, acromegaly, Paget disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis (pseudogout) or calcium pyrophosphate deposition disease.
- •Current treatment with beta-receptor adrenergic antagonists (beta-blockers), systemic corticosteroid treatment in doses equivalent to > 10 mg of prednisolone per day, or Vitamin K antagonists, new oral anticoagulants, fractionated and non-fractionated heparin
- •Active systemic infection.
- •Active systemic inflammatory or autoimmune disease.
- •Symptomatic occlusive arterial disease e.g. claudication intermittens.
- •Heart failure > NYHA class II.
- •History of transient ischaemic attack or stroke.
- •ECG findings which, in the opinion of the investigator, compromises patient safety related to HRmax-test.
- •History of coronary artery disease, myocardial infarction, or other serious cardiovascular disease, as evaluated by the investigator.
- •Is not currently active athlete or a highly trained individual.
- •Inclusion criteria for healthy subjects:
- •18 to < 75 years of age at the time of signing the informed consent form.
- •Have a bodyweight within > 50 and < 150 kg and a BMI within the range 18,5-35 kg/m
- •Are male or female.
- •Is able to meet for all of the four study visits and comply with the dietary and activity restrictions.
- •Can give informed consent.
- •Exclusion criteria for healthy subjects:
- •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 of having major surgery during the timeframe of this study.
- •Secondary OA e.g. because of dysplasia, aseptic osteonecrosis, acromegaly, Paget disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis (pseudogout) or calcium pyrophosphate deposition disease.
- •Current treatment with beta-receptor adrenergic antagonists (beta-blockers), systemic corticosteroid treatment in doses equivalent to > 10 mg of prednisolone per day, or Vitamin K antagonists, new oral anticoagulants, fractionated and non-fractionated heparin
- •Any known active systemic infection.
- •Any known active systemic inflammatory or autoimmune disease.
- •Symptomatic occlusive arterial disease e.g. Inermittent claudication.
- •Heart failure > NYHA class II.
- •History of transient ischaemic attack or stroke.
- •History of coronary artery disease, myocardial infarction, or other serious cardiovascular disease, as evaluated by the investigator.
- •ECG findings which, in the opinion of the investigator, compromises patient safety related to HRmax-test.
- •Is not currently active athlete or a highly trained individual.
- •X-ray verified Kellgren-Lawrence grade 1-
- •Is clinically suspected of having hip OA.
- •Other exclusions (all subjects):
- •Legal incapacity or limited legal capacity
- •Inability to communicate or cooperate with the investigator or to comply with the requirements of the entire study.
- •Are 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 24 hours prior to study intervention.
- •Other factors e.g. self-reported drug abuse, which in the opinion of the investigator may interfere with the study conduct.
- •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
研究组 & 干预措施
Cycling first
Other
Ergometer cycling then treadmill running then rest
干预措施: Ergometer Cycling followed by treadmill running (Other)
Cycling first
Other
Ergometer cycling then treadmill running then rest
干预措施: Rest (Other)
Running first
Other
Treadmill running then ergometer cycling then rest
干预措施: Treadmill Running followed by ergometer cycling (Other)
Running first
Other
Treadmill running then ergometer cycling then rest
干预措施: Rest (Other)
结局指标
主要结局
Changes in biomarkers (exploratory)
时间窗: Acute: 0-4 hours and subacute: 24 hours
Serum and urine biochemical markers of collagen and proteoglycan turnover
次要结局
未报告次要终点
研究者
研究点 (1)
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