Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-04 @ 10:43 PM
Study NCT ID:
NCT02995460
Status:
COMPLETED
Last Update Posted:
2018-11-13
First Post:
2016-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interval Training Study in Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-08', 'studyFirstSubmitDate': '2016-12-14', 'studyFirstSubmitQcDate': '2016-12-14', 'lastUpdatePostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient global assesment (PGA)', 'timeFrame': 'Baseline, 3 months (right after intervention), 9 months', 'description': 'PGA is measured as a change between timepoints. PGA is registered by the patient on a visual analog scale.'}, {'measure': 'Maximal oxygen uptake (VO2 max)', 'timeFrame': 'Baseline, 3 months (right after intervention), 9 months', 'description': 'The VO2 max is measured as a change between timepoints'}], 'secondaryOutcomes': [{'measure': 'Total lean mass', 'timeFrame': 'Baseline, 3 months (right after intervention), 9 months', 'description': 'Total lean mass is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).'}, {'measure': 'Total body fat', 'timeFrame': 'Baseline, 3 months (right after intervention), 9 months', 'description': 'Total body fat is measured as a change between timepoints and is measured by dual energy x-ray absorptiometry (DXA).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exercise Therapy'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '29882634', 'type': 'RESULT', 'citation': 'Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Impact of High-Intensity Interval Training on Disease Activity and Disease in Patients With Psoriatic Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2019 Apr;71(4):530-537. doi: 10.1002/acr.23614.'}, {'pmid': '30402265', 'type': 'RESULT', 'citation': 'Thomsen RS, Nilsen TIL, Haugeberg G, Bye A, Kavanaugh A, Hoff M. Effect of high-intensity interval training on cardiovascular disease risk factors and body composition in psoriatic arthritis: a randomised controlled trial. RMD Open. 2018 Oct 11;4(2):e000729. doi: 10.1136/rmdopen-2018-000729. eCollection 2018.'}, {'pmid': '37726677', 'type': 'DERIVED', 'citation': 'Thomsen RS, Nilsen TIL, Haugeberg G, Sitter B, Kavanaugh A, Pedersen SJ, Hoff M. Changes of inflammation in patients with psoriatic arthritis after high intensity interval training assessed by ultrasound and MRI, a randomized controlled trial. BMC Musculoskelet Disord. 2023 Sep 19;24(1):743. doi: 10.1186/s12891-023-06871-3.'}, {'pmid': '29179748', 'type': 'DERIVED', 'citation': 'Chronaiou I, Thomsen RS, Huuse EM, Euceda LR, Pedersen SJ, Hoff M, Sitter B. Quantifying bone marrow inflammatory edema in the spine and sacroiliac joints with thresholding. BMC Musculoskelet Disord. 2017 Nov 28;18(1):497. doi: 10.1186/s12891-017-1861-1.'}]}, 'descriptionModule': {'briefSummary': 'Psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced physical function. Patients have a higher risk of cardiovascular disease and a higher body mass index.\n\nA pilot study in patients with rheumatoid arthritis has shown positive effect on inflammation after 12 weeks of high-intensity interval training.\n\nThe primary aim of this study is to determine whether high-intensity interval training affects the disease activity in psoriatic arthritis. This intervention is believed to result in benefits in terms of inflammation, body composition and risk factors for cardiovascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fulfilling the CASPAR criteria of psoriatic arthritis\n* ability to exercise.\n\nExclusion Criteria:\n\n* Inability to exercise\n* very high disease Activity\n* unstable ischemic cardiovascular disease\n* severe pulmonary disease\n* pregnancy\n* breastfeeding\n* drug- and alcohol addictions'}, 'identificationModule': {'nctId': 'NCT02995460', 'briefTitle': 'Interval Training Study in Psoriatic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Interval Training Study in Psoriatic Arthritis', 'orgStudyIdInfo': {'id': '2012/1646'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'interval training', 'description': '4x4 high intensity interval training was performed on a stationary bicycle with a supervisor twice a week and by one self-training a week.', 'interventionNames': ['Behavioral: interval training']}, {'type': 'NO_INTERVENTION', 'label': 'controls', 'description': 'No change in diet and training habits'}], 'interventions': [{'name': 'interval training', 'type': 'BEHAVIORAL', 'description': '4x4 high intensity interval training', 'armGroupLabels': ['interval training']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Siri Forsmo, md prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Midt-Norge', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}