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OpenTrials
Completed

NCT Number: NCT04542668

The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

Medical conditions:

  • Osteoarthritis Kellgren-Lawrence radiological grade of 4 in one or both knees.
  • Cumulated osteoarthritis Kellgren-Lawrence radiological grade no higher than 1.
  • 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.

Treatment and study plan

Cycling then running

Other

Ergometer cycling Treadmill running

Other names: Exercise

Running then cycling

Other

Treadmill running Ergometer cycling

Other names: Exercise

Inotropy

Other

Adrenaline induced inotropy

Other names: Exercise simulation

Resting

Other

Subjects must be minimally physically active

Other names: Non-Ex

Primary outcomes

  1. Acute chances in biomarkers

    Time frame: Acute: 0-4 hours and subacute: 24 hours

    Serum and urine biochemical markers of joint related collagens and proteoglycan (not further specified)

Sponsors and collaborators

Lead sponsor

Nordic Bioscience A/S

Industry

Collaborators

  • NBCD A/S
  • University of Copenhagen

Registry information

Official study title

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

Acronym: EFEX-OA-02

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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