The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis
NCT ID: NCT04542668
Last Updated: 2021-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-10-08
2021-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Cycling as first intervention
Cycling -\> Running -\> Inotropy -\> Resting
Cycling then running
Ergometer cycling Treadmill running
Inotropy
Adrenaline induced inotropy
Resting
Subjects must be minimally physically active
Running as first intervention
Running -\> Cycling -\> Inotropy -\> Resting
Running then cycling
Treadmill running Ergometer cycling
Inotropy
Adrenaline induced inotropy
Resting
Subjects must be minimally physically active
Interventions
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Cycling then running
Ergometer cycling Treadmill running
Running then cycling
Treadmill running Ergometer cycling
Inotropy
Adrenaline induced inotropy
Resting
Subjects must be minimally physically active
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 40 to \< 75 years of age at time of signing the informed consent.
3. Body weight \> 50 and \< 100 kg and BMI in the range 18.5-35 kg/m2 .
4. Male or female.
5. Able to attend all four study sessions and comply with the dietary and activity restrictions.
6. Able to provide informed consent
Exclusion Criteria
1. Osteoarthritis Kellgren-Lawrence radiological grade of 4 in one or both knees.
2. Cumulated osteoarthritis Kellgren-Lawrence radiological grade no higher than 1.
3. History of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening.
4. Previous arthroplasty of knee or hip.
5. Intention to have major surgery during the timeframe of the study.
6. 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).
7. 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.
8. Active systemic infection.
9. Active systemic inflammatory or autoimmune disease.
10. Any sign of previous or current cardiovascular disease.
11. Not currently an active athlete or highly trained individual.
1. Legal incapacity or limited legal capacity.
2. Inability to communicate or cooperate with the investigator or to comply with the requirements of the entire study.
3. Categorized as being very difficult to draw blood from, as evaluated by the investigator.
4. Current alcohol abuse and/or inability to refrain from intake of alcoholic beverages for 24 hours prior to the study intervention.
5. Other factors, e.g. self-reported drug abuse, which in the opinion of the investigator may interfere with the performance of the study.
6. Site staff, study staff members and study staff family members.
7. Other concomitant disease compromising or otherwise significantly affecting ECM turnover in the opinion of the investigator.
40 Years
75 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
NBCD A/S
INDUSTRY
Nordic Bioscience A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Niels Secher, MD, DMSci
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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Other Identifiers
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EFEX-OA-02_FINAL_Protocol_v1.2
Identifier Type: -
Identifier Source: org_study_id
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