Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT01091194
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2010-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exercise After Heart Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-18', 'studyFirstSubmitDate': '2010-03-18', 'studyFirstSubmitQcDate': '2010-03-22', 'lastUpdatePostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak oxygen uptake (VO2peak)', 'timeFrame': 'Before and after the intervention period of 1 year'}], 'secondaryOutcomes': [{'measure': 'Isokinetic muscle strength of quadriceps and hamstrings', 'timeFrame': 'Before and after the intervention period of 1 year'}, {'measure': 'Quality of life measured by questionnaires', 'timeFrame': 'Before and after the intervention period of 1 year'}, {'measure': 'Myocardial function measured by echocardiography', 'timeFrame': 'Before and after the intervention period of 1 year'}, {'measure': 'Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS)', 'timeFrame': 'Before and after the intervention period of 1 year'}, {'measure': 'Vascular tone and compliance measured by tonometry', 'timeFrame': 'Before and after the intervention period of 1 year'}, {'measure': 'Regular blood screening, lipid profile, inflammatory status, nerve growth factor, biochemical markers for endothelial function, prothrombotic factor, factors connected to vascularization: NT-proBNP and gene expression analysis.', 'timeFrame': 'Before and after the intervention period of 1 year'}, {'measure': 'Analysis of isolated muscle cells from myocardial biopsy', 'timeFrame': 'Before and after the intervention period of 1 year'}, {'measure': 'Reinnervation as judged by autonomic nervous control (Heart Rate Variability)', 'timeFrame': 'Before and after the intervention period of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Transplantation', 'Aerobic Exercise', 'Exercise, Physical', 'Exercise Test', 'Treadmill Test', 'VO2 peak', 'Muscle Strength', 'Quality of Life', 'Reinnervation', 'Heart Rate', 'Myocardial Function'], 'conditions': ['Heart Transplantation']}, 'referencesModule': {'references': [{'pmid': '22900793', 'type': 'RESULT', 'citation': 'Nytroen K, Rustad LA, Aukrust P, Ueland T, Hallen J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Transplant. 2012 Nov;12(11):3134-42. doi: 10.1111/j.1600-6143.2012.04221.x. Epub 2012 Aug 17.'}, {'pmid': '23185084', 'type': 'RESULT', 'citation': 'Rustad LA, Nytroen K, Amundsen BH, Gullestad L, Aakhus S. One year of high-intensity interval training improves exercise capacity, but not left ventricular function in stable heart transplant recipients: a randomised controlled trial. Eur J Prev Cardiol. 2014 Feb;21(2):181-91. doi: 10.1177/2047487312469477. Epub 2012 Nov 26.'}, {'pmid': '22659939', 'type': 'RESULT', 'citation': 'Nytroen K, Rustad LA, Gude E, Hallen J, Fiane AE, Rolid K, Holm I, Aakhus S, Gullestad L. Muscular exercise capacity and body fat predict VO(2peak) in heart transplant recipients. Eur J Prev Cardiol. 2014 Jan;21(1):21-9. doi: 10.1177/2047487312450540. Epub 2012 Jun 1.'}, {'pmid': '32518655', 'type': 'DERIVED', 'citation': 'Nytroen K, Rolid K, Yardley M, Gullestad L. Effect of high-intensity interval training in young heart transplant recipients: results from two randomized controlled trials. BMC Sports Sci Med Rehabil. 2020 Jun 4;12:35. doi: 10.1186/s13102-020-00180-1. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial which will include approximately 50 heart transplant recipients 1-8 years after heart transplantation. The intervention and follow up period is 1 year. The primary purpose is to investigate if systematic, high intensity, interval-based aerobic exercise training results in a greater improvement of exercise capacity (measured by VO2peak) than previously shown in heart transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Norwegian heart transplanted patients \\> 18 years of age\n* 1-8 years after heart transplantation\n* Optimal medical treatment\n* Stable condition\n* Written informed consent\n* Must have access to a physical therapist or personal trainer in their hometown\n* Motivation for exercise\n\nExclusion Criteria:\n\n* Unstable condition\n* In need of revascularization or other invention\n* Infections, open wounds or skin diseases\n* Physical disabilities which prevent participation\n* Other diseases, illnesses or conditions which contradict exercise'}, 'identificationModule': {'nctId': 'NCT01091194', 'acronym': 'TEX', 'briefTitle': 'Effect of Exercise After Heart Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.', 'orgStudyIdInfo': {'id': '10920'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Exercise', 'description': 'Interval-based aerobic exercise', 'interventionNames': ['Other: Interval-based aerobic exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention other than regular follow up hospital visits'}], 'interventions': [{'name': 'Interval-based aerobic exercise', 'type': 'OTHER', 'otherNames': ['physical activity, fitness'], 'description': 'High intensity interval-based aerobic exercise training. Duration: 1 year. Three 8-weeks supervised periods of physical training 3 times per week. Individual training 2 times per week between these periods.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Department of Cardiology, Oslo University Hospital, Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Lars Gullestad, MD,PhD,Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Sor-Ost', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}