The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis (EFEX-OA-01)

Inclusion criteria

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/m2.
• 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 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/m2.
• 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 1-4.
• 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