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

NCT04542668 | Completed

• 1 other identifier: EFEX-OA-02_FINAL_Protocol_v1.2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Acute chances in biomarkers

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

  Acute: 0-4 hours and subacute: 24 hours

Study Arms (2)

Cycling as first intervention

OTHER

Cycling -\> Running -\> Inotropy -\> Resting

Other: Cycling then running; Other: Inotropy; Other: Resting

Running as first intervention

OTHER

Running -\> Cycling -\> Inotropy -\> Resting

Other: Running then cycling; Other: Inotropy; Other: Resting

Interventions

Cycling then running OTHER

Ergometer cycling Treadmill running

Also known as: Exercise

Cycling as first intervention

Running then cycling OTHER

Treadmill running Ergometer cycling

Also known as: Exercise

Running as first intervention

Inotropy OTHER

Adrenaline induced inotropy

Also known as: Exercise simulation

Cycling as first intervention; Running as first intervention

Resting OTHER

Subjects must be minimally physically active

Also known as: Non-Ex

Cycling as first intervention; Running as first intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

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

• Niels Secher, MD, DMSci

  University of Copenhagen

  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: 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.

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: October 8, 2020
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)