Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-30 @ 4:35 AM
Study NCT ID:
NCT04542668
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2020-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-07', 'studyFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute chances in biomarkers', 'timeFrame': 'Acute: 0-4 hours and subacute: 24 hours', 'description': 'Serum and urine biochemical markers of joint related collagens and proteoglycan (not further specified)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cumulated Osteoarthritis Kellgren-Lawrence radiological grade of at least 2 in the tibio-femoral joints diagnosed by screening X-ray.\n2. 40 to \\< 75 years of age at time of signing the informed consent.\n3. Body weight \\> 50 and \\< 100 kg and BMI in the range 18.5-35 kg/m2 .\n4. Male or female.\n5. Able to attend all four study sessions and comply with the dietary and activity restrictions.\n6. Able to provide informed consent\n\nExclusion Criteria:\n\nMedical conditions:\n\n1. Osteoarthritis Kellgren-Lawrence radiological grade of 4 in one or both knees.\n2. Cumulated osteoarthritis Kellgren-Lawrence radiological grade no higher than 1.\n3. History of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening.\n4. Previous arthroplasty of knee or hip.\n5. Intention to have major surgery during the timeframe of the study.\n6. 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).\n7. 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.\n8. Active systemic infection.\n9. Active systemic inflammatory or autoimmune disease.\n10. Any sign of previous or current cardiovascular disease.\n11. Not currently an active athlete or highly trained individual.\n\nOther exclusion criteria:\n\n1. Legal incapacity or limited legal capacity.\n2. Inability to communicate or cooperate with the investigator or to comply with the requirements of the entire study.\n3. Categorized as being very difficult to draw blood from, as evaluated by the investigator.\n4. Current alcohol abuse and/or inability to refrain from intake of alcoholic beverages for 24 hours prior to the study intervention.\n5. Other factors, e.g. self-reported drug abuse, which in the opinion of the investigator may interfere with the performance of the study.\n6. Site staff, study staff members and study staff family members.\n7. Other concomitant disease compromising or otherwise significantly affecting ECM turnover in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT04542668', 'acronym': 'EFEX-OA-02', 'briefTitle': 'The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nordic Bioscience A/S'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EFEX-OA-02_FINAL_Protocol_v1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cycling as first intervention', 'description': 'Cycling -\\> Running -\\> Inotropy -\\> Resting', 'interventionNames': ['Other: Cycling then running', 'Other: Inotropy', 'Other: Resting']}, {'type': 'OTHER', 'label': 'Running as first intervention', 'description': 'Running -\\> Cycling -\\> Inotropy -\\> Resting', 'interventionNames': ['Other: Running then cycling', 'Other: Inotropy', 'Other: Resting']}], 'interventions': [{'name': 'Cycling then running', 'type': 'OTHER', 'otherNames': ['Exercise'], 'description': 'Ergometer cycling Treadmill running', 'armGroupLabels': ['Cycling as first intervention']}, {'name': 'Running then cycling', 'type': 'OTHER', 'otherNames': ['Exercise'], 'description': 'Treadmill running Ergometer cycling', 'armGroupLabels': ['Running as first intervention']}, {'name': 'Inotropy', 'type': 'OTHER', 'otherNames': ['Exercise simulation'], 'description': 'Adrenaline induced inotropy', 'armGroupLabels': ['Cycling as first intervention', 'Running as first intervention']}, {'name': 'Resting', 'type': 'OTHER', 'otherNames': ['Non-Ex'], 'description': 'Subjects must be minimally physically active', 'armGroupLabels': ['Cycling as first intervention', 'Running as first intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Niels Secher, MD, DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordic Bioscience A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'NBCD A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}