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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04542668

Acronym

EFEX-OA-02

Enrollment

Registered

2020-09-09

Start date

2020-10-08

Completion date

2021-06-07

Last updated

2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Brief summary

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.

Interventions

OTHERCycling then running

Ergometer cycling Treadmill running

OTHERRunning then cycling

Treadmill running Ergometer cycling

OTHERInotropy

Adrenaline induced inotropy

OTHERResting

Subjects must be minimally physically active

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

The study period will be 4 weeks. In each week, the subjects will undergo a different physical activity intervention. The order of the interventions will be randomized. The interventions will be separated by a minimum of 4 days. Inteventions: Cycling, Running, exercise-simulation with inotropy and resting.

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Cumulated Osteoarthritis Kellgren-Lawrence radiological grade of at least 2 in the tibio-femoral joints diagnosed by screening X-ray. 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

Medical conditions: 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. Other

Design outcomes

Primary

Measure	Time frame	Description
Acute chances in biomarkers	Acute: 0-4 hours and subacute: 24 hours	Serum and urine biochemical markers of joint related collagens and proteoglycan (not further specified)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026