Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-02-24 @ 3:53 AM
Study NCT ID:
NCT02602834
Status:
COMPLETED
Last Update Posted:
2016-11-10
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imminently Effect of Interval Training With High Intensity (HIT) After Heart Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-09', 'studyFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in crp with interval training compared to moderate training', 'timeFrame': '1 week'}, {'measure': 'Changes in interleukin levels with interval training compared to moderate training', 'timeFrame': '1 week'}, {'measure': 'Changes in ICAM levels with interval training compared to moderate training', 'timeFrame': '1 week'}, {'measure': 'Changes in MiRNA levels with interval training compared to moderate training', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'Questionnaire of quality of life', 'timeFrame': 'baseline'}, {'measure': 'Oxygen uptake', 'timeFrame': 'baseline', 'description': 'V02 peak measured på exercise test on treadmill.'}, {'measure': 'Questionnaire of physical activity', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exercise test', 'biological markers'], 'conditions': ['Heart Transplantation']}, 'referencesModule': {'references': [{'pmid': '29225901', 'type': 'DERIVED', 'citation': 'Yardley M, Ueland T, Aukrust P, Michelsen A, Bjorkelund E, Gullestad L, Nytroen K. Immediate response in markers of inflammation and angiogenesis during exercise: a randomised cross-over study in heart transplant recipients. Open Heart. 2017 Nov 28;4(2):e000635. doi: 10.1136/openhrt-2017-000635. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'High intensity Interval training (HIT) has repeatedly been documented to have superior positive effects on oxygen uptake and general physical health compared to continuous moderate exercise in healthy individuals and patients with heart disease. Recently, the same effect has been shown in heart transplanted recipients. Which mechanisms that explains this difference is uncertain; the effect can be due to changes in the heart or changes in the peripheral tissue and muscles. To explore these mechanisms the investigators will in this study compare two different exercise modalities, and explore how different biomarkers change in blood, related to exercise.', 'detailedDescription': '15 heart transplanted recipients (and 5 healthy controls) will be included in the study. Each patient will have three study-days.\n\nThe study is designed to be a cross-over study. And randomisation will decide which training they will have som training session 1 and training session 2; Interval or continuous training.\n\nBefore starting the two training sessions they will measure oxygen uptake and baseline blood samples.\n\nDuring each exercise session the patients will take blood samples during and after exercise.\n\nAfter first study admission the patients will have a wash out period for 1 week until first training session, and another week until the last session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (HTx):\n\n* 1-10 years after heart transplantation\n* Lives in Oslo or near Oslo\n* Stable health condition\n* Optimal medical treatment/ medication\n* No limiting physical handicap\n* Written consent\n\nInclusion healthy control:\n\n* No verified heart disease\n* Willing to preform the study\n* Over 18 years\n* Written consent\n\nExclusion Criteria:\n\n* Under 1 year or over 10 year since HTx.\n* Lives far from Oslo\n* Unstable health condition\n* Not optimal medical treatment and/ or medication\n* Limiting physical handicap\n* Under 18 years\n* Not written consent'}, 'identificationModule': {'nctId': 'NCT02602834', 'briefTitle': 'Imminently Effect of Interval Training With High Intensity (HIT) After Heart Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Changes in Blood Measured Before, During and After Exercise in Heart Transplant Recipients. Imminently Effect of Interval Training With High Intensity Compared With Continuous Moderate Intensity', 'orgStudyIdInfo': {'id': '2015/97/REK sør-øst A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HTx', 'description': 'Heart transplant recipients n=15', 'interventionNames': ['Other: interval training', 'Other: moderate exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Healthy controls n=5', 'interventionNames': ['Other: interval training', 'Other: moderate exercise']}], 'interventions': [{'name': 'interval training', 'type': 'OTHER', 'description': '4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.', 'armGroupLabels': ['Control', 'HTx']}, {'name': 'moderate exercise', 'type': 'OTHER', 'description': '30 minutes (moderate intensity) aerobic exercise on treadmill without rest.', 'armGroupLabels': ['Control', 'HTx']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'OUS- Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Lars LG Gullestad, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'OUS-Oslo university hospital rikshospitalet, cardiology department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Health Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD candidate', 'investigatorFullName': 'Marianne Yardley', 'investigatorAffiliation': 'Oslo University Hospital'}}}}