Osteoarthritis, KneeEFEX-OA-02NCT04542668
The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis
A study testing Cycling then running, Running then cycling and Inotropy in people with Osteoarthritis, Knee, run by Nordic Bioscience A/S at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Cycling then running, Running then cycling and Inotropy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Oct 2020to 7 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Cycling then running, Running then cycling, Inotropy, Resting
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling then runningOther
Also called Exercise
Ergometer cycling Treadmill running
Running then cyclingOther
Also called Exercise
Treadmill running Ergometer cycling
InotropyOther
Also called Exercise simulation
Adrenaline induced inotropy
RestingOther
Also called Non-Ex
Subjects must be minimally physically active
| Study group | Role | What they receive |
|---|---|---|
| Cycling as first intervention | Other | Cycling -> Running -> Inotropy -> Resting Receives: Other: Cycling then running; Other: Inotropy; Other: Resting |
| Running as first intervention | Other | Running -> Cycling -> Inotropy -> Resting Receives: Other: Running then cycling; Other: Inotropy; Other: Resting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute chances in biomarkers
Serum and urine biochemical markers of joint related collagens and proteoglycan (not further specified)
Measured: Acute: 0-4 hours and subacute: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start8 Oct 2020
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Bioscience A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Copenhagen, NBCD A/S
- Responsible party
- Sponsor
- Investigators
- Niels Secher, MD, DMSci, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542668
- Sponsor's protocol ID
- EFEX-OA-02_FINAL_Protocol_v1.2
- Acronym
- EFEX-OA-02
- Status last verified
- Jun 2021
- First submitted
- 27 Aug 2020
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjerre-Bastos JJ, Sejersen C, Nielsen HB, Boesen M, Secher NH, Distajo G, Flood V, Henrotin Y, Uebelhoer M, Krustrup P, Kitchen CC, Thudium CS, Andersen JR, Bihlet AR. The Impact of Weight-bearing Exercise, Non-Weight-bearing Exercise, and Cardiovascular Stress on Biochemical Markers of Cartilage Turnover in Patients With Mild to Moderate Knee Osteoarthritis - A Sequential, Cross-Over, Clinical Study. Cartilage. 2025 Jun;16(2):159-168. doi: 10.1177/19476035241258170. Epub 2024 Jun 9.
PubMed 38853398
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04542668
- Acronym / sponsor ID
- EFEX-OA-02 / EFEX-OA-02_FINAL_Protocol_v1.2
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nordic Bioscience A/SIndustry (pharma, biotech, devices)
- Collaborators
- University of Copenhagen, NBCD A/S
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cycling as first intervention | Other | Other: Cycling then running, Other: Inotropy, Other: RestingCycling -> Running -> Inotropy -> Resting |
| Running as first intervention | Other | Other: Running then cycling, Other: Inotropy, Other: RestingRunning -> Cycling -> Inotropy -> Resting |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycling then runningAlso: ExerciseErgometer cycling Treadmill running | Other | Cycling as first intervention |
| Running then cyclingAlso: ExerciseTreadmill running Ergometer cycling | Other | Running as first intervention |
| InotropyAlso: Exercise simulationAdrenaline induced inotropy | Other | Cycling as first intervention, Running as first intervention |
| RestingAlso: Non-ExSubjects must be minimally physically active | Other | Cycling as first intervention, Running as first intervention |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Derived from this study: PubMed 38853398Bjerre-Bastos JJ, Sejersen C, Nielsen HB, Boesen M, Secher NH, Distajo G, Flood V, Henrotin Y, Uebelhoer M, Krustrup P, Kitchen CC, Thudium CS, Andersen JR, Bihlet AR. The Impact of Weight-bearing Exercise, Non-Weight-bearing Exercise, and Cardiovascular Stress on Biochemical Markers of Cartilage Turnover in Patients With Mild to Moderate Knee Osteoarthritis - A Sequential, Cross-Over, Clinical Study. Cartilage. 2025 Jun;16(2):159-168. doi: 10.1177/19476035241258170. Epub 2024 Jun 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Secher, MD, DMSci principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling then running, Running then cycling and Inotropy in people with Osteoarthritis, Knee, run by Nordic Bioscience A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute chances in biomarkers (time frame: Acute: 0-4 hours and subacute: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04542668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.