Osteoarthritis, Knee
Conditions
Brief summary
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.
Interventions
OTHERErgometer Cycling followed by treadmill running
The participants undergo ergometer cycling, treadmill running and rest.
OTHERTreadmill Running followed by ergometer cycling
The participants undergo treadmill running, ergometer cycling and rest.
OTHERRest
The participants undergo ergometer cycling, treadmill running and rest.
Sponsors
University of Copenhagen
NBCD A/S
Nordic Bioscience A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Participants will be randomized to an order of exercise-intervention: cycling, running. This will be followed by a resting intervention. Interventions are planned 1 week apart. Blood will be sampled before, immediately after and again at 1, 2, 3 and 24 hours after intervention start. Spot urine is sampled before, after and the next day.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
for OA patients: 1. Kellgren-Lawrence radiological grade of 1-3 in at least one tibio-femoral joint diagnosed by screening x-ray. 2. 35 to \< 75 years of age at the time of signing the informed consent form. 3. Bodyweight \> 50 and \< 150 kg and a BMI in the range 18,5-35 kg/m2. 4. Are male or female. 5. Is able to meet for all of the four study visits and comply with the dietary and activity restrictions. 6. Can give informed consent.
Exclusion criteria
for OA patients: Medical conditions: 1. History of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening. 2. Kellgren-Lawrence radiological grade of 4 in at least one tibio-femoral joint 3. Previous arthroplasty of knee or hip. 4. Intention of having major surgery during the timeframe of this study. 5. OA related to eg. dysplasia, aseptic osteonecrosis, acromegaly, Paget disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis (pseudogout) or calcium pyrophosphate deposition disease. 6. 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 7. Active systemic infection. 8. Active systemic inflammatory or autoimmune disease. 9. Symptomatic occlusive arterial disease e.g. claudication intermittens. 10. Heart failure \> NYHA class II. 11. History of transient ischaemic attack or stroke. 12. ECG findings which, in the opinion of the investigator, compromises patient safety related to HRmax-test. 13. History of coronary artery disease, myocardial infarction, or other serious cardiovascular disease, as evaluated by the investigator. 14. Is not currently active athlete or a highly trained individual. Inclusion criteria for healthy subjects: 1. 18 to \< 75 years of age at the time of signing the informed consent form. 2. Have a bodyweight within \> 50 and \< 150 kg and a BMI within the range 18,5-35 kg/m2. 3. Are male or female. 4. Is able to meet for all of the four study visits and comply with the dietary and activity restrictions. 5. Can give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in biomarkers (exploratory) | Acute: 0-4 hours and subacute: 24 hours | Serum and urine biochemical markers of collagen and proteoglycan turnover |
Countries
Denmark
Outcome results
None listed