The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis (EFEX-OA-01)

NCT04542655 | Completed

• 1 other identifier: EFEX-OA_Protocol_Final_v1.1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Changes in biomarkers (exploratory)

  Serum and urine biochemical markers of collagen and proteoglycan turnover

  Acute: 0-4 hours and subacute: 24 hours

Study Arms (2)

Cycling first

OTHER

Ergometer cycling then treadmill running then rest

Other: Ergometer Cycling followed by treadmill running; Other: Rest

Running first

OTHER

Treadmill running then ergometer cycling then rest

Other: Treadmill Running followed by ergometer cycling; Other: Rest

Interventions

Ergometer Cycling followed by treadmill running OTHER

The participants undergo ergometer cycling, treadmill running and rest.

Also known as: Exercise

Cycling first

Treadmill Running followed by ergometer cycling OTHER

The participants undergo treadmill running, ergometer cycling and rest.

Also known as: Exercise

Running first

Rest OTHER

The participants undergo ergometer cycling, treadmill running and rest.

Also known as: Non Exercise

Cycling first; Running first

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kellgren-Lawrence radiological grade of 1-3 in at least one tibio-femoral joint diagnosed by screening x-ray.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nordic Bioscience A/S: lead
• University of Copenhagen: collaborator
• NBCD A/S: collaborator

Study Sites (1)

Sanos Clinic

Herlev, 2730, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34156534 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Henning Nielsen, MD, DMSci

  Sanos Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: January 7, 2019
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)