Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT06824805
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2025-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypertension, Ethnicity and Exercise Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'office blood pressure at 30 minutes post exercise', 'timeFrame': '30 minutes postexercsie', 'description': 'office blood pressure at 30 minutes post exercise'}], 'secondaryOutcomes': [{'measure': 'daytime blood pressure', 'timeFrame': 'mean of 8 hours after the intervention', 'description': 'daytime ambulatory blood pressure (8 hours after the intervention)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to investigate the acute effects of a single bout of isometric handgrip exercise (IHG) and a single bout of aerobic endurance exercise (AEX) on blood pressure, both immediately after exercise and during the subsequent activities of daily living in patients with high-normal to grade 1 hypertension of South-Asian or African descent living in Suriname.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age 18 - 65 years\n\n * Patients with high- normal BP (SBP: 130 - 139 mmHg or and DBP: 85 - 89 mmHg) or stage I hypertension (SBP: 140 - 159 mmHg or DBP: 90 - 99 mmHg) according to the ESC/ESH guidelines \\[15\\]\n * Asian or African descent\n * Do not meet the level of physical activity recommended by the WHO based on self-report \\[15\\]\n * Non-medicated patients or patients using a maximum of 2 antihypertensive drugs\n\nExclusion Criteria:\n\n* • Functional or mental limitation limiting the correct execution of an exercise bout\n\n * History of ischemic stroke, autonomic neuropathy, cardiovascular, renal, or pulmonary disease by self-report\n * Diabetes type I or II\n * Pregnancy\n * The presence of exercise induced signs of myocardial ischemia or complex ventricular arrhythmia during CPET\n * Patients using three or more antihypertensive drugs or patients with resistant hypertension'}, 'identificationModule': {'nctId': 'NCT06824805', 'acronym': 'HYPE2X', 'briefTitle': 'Hypertension, Ethnicity and Exercise Trial', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Hypertension, Ethnicity and Exercise Trial', 'orgStudyIdInfo': {'id': '183/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'isometric handgrip exercise', 'description': '4x2 minutes of isometric handgrip exercise', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'seated control session'}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic exercise', 'description': 'aerobic exercise at 40-60% HRres', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'aerobic exercise for 30 minutes at 40-60% HRres', 'armGroupLabels': ['Aerobic exercise', 'isometric handgrip exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paramaribo', 'country': 'Suriname', 'facility': 'Anton De Kom University', 'geoPoint': {'lat': 5.86638, 'lon': -55.16682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Véronique Cornelissen', 'investigatorAffiliation': 'KU Leuven'}}}}