Osteoarthritis, KneeEFEX-OA-01NCT04542655
The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis (EFEX-OA-01)
A study testing Ergometer Cycling followed by treadmill running, Treadmill Running followed by ergometer cycling and Rest in people with Osteoarthritis, Knee, run by Nordic Bioscience A/S at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Ergometer Cycling followed by treadmill running, Treadmill Running followed by ergometer cycling and Rest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jan 2019to 14 May 2019
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Kellgren-Lawrence radiological grade of 1-3 in at least one tibio-femoral joint diagnosed by screening x-ray.
- 35 to < 75 years of age at the time of signing the informed consent form.
- Bodyweight > 50 and < 150 kg and a BMI in the range 18,5-35 kg/m2.
- Are male or female.
- Is able to meet for all of the four study visits and comply with the dietary and activity restrictions.
- Can give informed consent.
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- 18 to < 75 years of age at the time of signing the informed consent form.
- Have a bodyweight within > 50 and < 150 kg and a BMI within the range 18,5-35 kg/m2.
- Are male or female.
- Is able to meet for all of the four study visits and comply with the dietary and activity restrictions.
- Can give informed consent.
Who cannot join
- Medical conditions:
- History of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening.
- Kellgren-Lawrence radiological grade of 4 in at least one tibio-femoral joint
- Previous arthroplasty of knee or hip.
- Intention of having major surgery during the timeframe of this study.
- OA related to eg. dysplasia, aseptic osteonecrosis, acromegaly, Paget disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis (pseudogout) or calcium pyrophosphate deposition disease.
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- 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
- Active systemic infection.
- Active systemic inflammatory or autoimmune disease.
- Symptomatic occlusive arterial disease e.g. claudication intermittens.
- Heart failure > NYHA class II.
- History of transient ischaemic attack or stroke.
- ECG findings which, in the opinion of the investigator, compromises patient safety related to HRmax-test.
- History of coronary artery disease, myocardial infarction, or other serious cardiovascular disease, as evaluated by the investigator.
- Is not currently active athlete or a highly trained individual.
- 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 of having major surgery during the timeframe of this study.
- Secondary OA e.g. because of dysplasia, aseptic osteonecrosis, acromegaly, Paget disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis (pseudogout) or calcium pyrophosphate deposition disease.
- 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
- Any known active systemic infection.
- Any known active systemic inflammatory or autoimmune disease.
- Symptomatic occlusive arterial disease e.g. Inermittent claudication.
- Heart failure > NYHA class II.
- History of transient ischaemic attack or stroke.
- History of coronary artery disease, myocardial infarction, or other serious cardiovascular disease, as evaluated by the investigator.
- ECG findings which, in the opinion of the investigator, compromises patient safety related to HRmax-test.
- Is not currently active athlete or a highly trained individual.
- X-ray verified Kellgren-Lawrence grade 1-4.
- Is clinically suspected of having hip OA.
- Other exclusions (all subjects):
- Legal incapacity or limited legal capacity
- Inability to communicate or cooperate with the investigator or to comply with the requirements of the entire study.
- Are 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 24 hours prior to study intervention.
- Other factors e.g. self-reported drug abuse, which in the opinion of the investigator may interfere with the study conduct.
- 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, Single-center, Randomized, Controlled, Exploratory Study to Investigate the Effect of Weight Bearing Versus Non-weight Bearing Exercise on Collagen and Proteoglycan in Serum and Urine in Patients With Osteoarthritis and Healthy Subjects
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Ergometer Cycling followed by treadmill running, Treadmill Running followed by ergometer cycling, Rest
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergometer Cycling followed by treadmill runningOther
Also called Exercise
The participants undergo ergometer cycling, treadmill running and rest.
Treadmill Running followed by ergometer cyclingOther
Also called Exercise
The participants undergo treadmill running, ergometer cycling and rest.
RestOther
Also called Non Exercise
The participants undergo ergometer cycling, treadmill running and rest.
| Study group | Role | What they receive |
|---|---|---|
| Cycling first | Other | Ergometer cycling then treadmill running then rest Receives: Other: Ergometer Cycling followed by treadmill running; Other: Rest |
| Running first | Other | Treadmill running then ergometer cycling then rest Receives: Other: Treadmill Running followed by ergometer cycling; Other: Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in biomarkers (exploratory)
Serum and urine biochemical markers of collagen and proteoglycan turnover
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 start7 Jan 2019
- Primary completion14 May 2019
- Study completion14 May 2019
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
- 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.
- 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
- Henning Nielsen, MD, DMSci, Principal investigator, Sanos Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542655
- Sponsor's protocol ID
- EFEX-OA_Protocol_Final_v1.1
- Acronym
- EFEX-OA-01
- Status last verified
- Feb 2021
- First submitted
- 27 Aug 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjerre-Bastos JJ, Nielsen HB, Andersen JR, Karsdal M, Boesen M, Mackey AL, Byrjalsen I, Thudium CS, Bihlet AR. A biomarker perspective on the acute effect of exercise with and without impact on joint tissue turnover: an exploratory randomized cross-over study. Eur J Appl Physiol. 2021 Oct;121(10):2799-2809. doi: 10.1007/s00421-021-04751-z. Epub 2021 Jun 22.
PubMed 34156534
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center, Randomized, Controlled, Exploratory Study to Investigate the Effect of Weight Bearing Versus Non-weight Bearing Exercise on Collagen and Proteoglycan in Serum and Urine in Patients With Osteoarthritis and Healthy Subjects
- ClinicalTrials.gov ID
- NCT04542655
- Acronym / sponsor ID
- EFEX-OA-01 / EFEX-OA_Protocol_Final_v1.1
- 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
- 7 Jan 2019 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 14 May 2019 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cycling first | Other | Other: Ergometer Cycling followed by treadmill running, Other: RestErgometer cycling then treadmill running then rest |
| Running first | Other | Other: Treadmill Running followed by ergometer cycling, Other: RestTreadmill running then ergometer cycling then rest |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Kellgren-Lawrence radiological grade of 1-3 in at least one tibio-femoral joint diagnosed by screening x-ray.
- 35 to < 75 years of age at the time of signing the informed consent form.
- Bodyweight > 50 and < 150 kg and a BMI in the range 18,5-35 kg/m2.
- Are male or female.
- Is able to meet for all of the four study visits and comply with the dietary and activity restrictions.
Key exclusion criteria (38 listed)
- History of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening.
- Kellgren-Lawrence radiological grade of 4 in at least one tibio-femoral joint
- Previous arthroplasty of knee or hip.
- Intention of having major surgery during the timeframe of this study.
- OA related to eg. dysplasia, aseptic osteonecrosis, acromegaly, Paget disease, Stickler syndrome, hemochromatosis, gout, chondrocalcinosis (pseudogout) or calcium pyrophosphate deposition disease.
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 |
|---|---|---|
| Ergometer Cycling followed by treadmill runningAlso: ExerciseThe participants undergo ergometer cycling, treadmill running and rest. | Other | Cycling first |
| Treadmill Running followed by ergometer cyclingAlso: ExerciseThe participants undergo treadmill running, ergometer cycling and rest. | Other | Running first |
| RestAlso: Non ExerciseThe participants undergo ergometer cycling, treadmill running and rest. | Other | Cycling first, Running first |
Primary outcome
Changes in biomarkers (exploratory)
Time frame: Acute: 0-4 hours and subacute: 24 hours
Serum and urine biochemical markers of collagen and proteoglycan turnover
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 15 Feb 2021.
- Derived from this study: PubMed 34156534Bjerre-Bastos JJ, Nielsen HB, Andersen JR, Karsdal M, Boesen M, Mackey AL, Byrjalsen I, Thudium CS, Bihlet AR. A biomarker perspective on the acute effect of exercise with and without impact on joint tissue turnover: an exploratory randomized cross-over study. Eur J Appl Physiol. 2021 Oct;121(10):2799-2809. doi: 10.1007/s00421-021-04751-z. Epub 2021 Jun 22.
- 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.
Henning Nielsen, MD, DMSci principal investigator
Sanos Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergometer Cycling followed by treadmill running, Treadmill Running followed by ergometer cycling and Rest 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 11 inclusion and 38 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 15 Feb 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?
Changes in biomarkers (exploratory) (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 NCT04542655, 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 15 Feb 2021.