Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-31 @ 4:02 AM
Study NCT ID:
NCT07147595
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Effect of Isometric Exercise on Blood Pressure in Patients With Hypertension
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bood pressure', 'timeFrame': 'Assessments (systolic/diastolic pressure) will be performed at baseline and after 4 weeks of training (post-intervention).', 'description': 'Bood pressure (systolic and diastolic) measured by Ambulatory Blood Pressure Monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension (HTN)', 'Hypertension Arterial']}, 'descriptionModule': {'briefSummary': 'International recommendations support dynamic or isometric strength training as an adjunct to aerobic exercise. Given the lack of consensus, this study aims to evaluate the chronic effects of isometric exercise, performed through handgrip or isometric knee extension, as a hypotensive strategy in adults with hypertension.', 'detailedDescription': 'This study is designed as a randomized, controlled, evaluator-blinded clinical trial, conducted entirely at the Laboratory of Clinical Investigation (LCI) of the Cardiology Institute of Rio Grande do Sul / University Foundation of Cardiology (ICFUC). The project follows all recommendations of the CONSORT Statement.\n\nMale and female participants aged 40 to 70 years, with blood pressure ≥ 120/80 mmHg, will be enrolled. After signing informed consent, participants will complete a questionnaire to assess their habitual physical activity level and will undergo isometric handgrip or isometric knee extension training for 4 weeks. Blood pressure will be assessed at baseline and after the intervention using ambulatory blood pressure monitoring (ABPM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with controlled hypertension under medication. Sedentary or physically inactive individuals.\n\nExclusion Criteria:\n\nPregnant women. Unstable angina. Heart failure classified as NYHA class II, III, or IV. Recent cardiovascular event within the last 3 months. Chronic renal insufficiency. Diabetes mellitus. History of malignant disease with a life expectancy of less than 2 years. Orthopedic, physical, or mental limitations that prevent the performance of physical exercise.'}, 'identificationModule': {'nctId': 'NCT07147595', 'briefTitle': 'Chronic Effect of Isometric Exercise on Blood Pressure in Patients With Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiologia do Rio Grande do Sul'}, 'officialTitle': 'Chronic Effect of Isometric Exercise on Blood Pressure in Patients With Controlled Hypertension: a Randomized Clinical Trail', 'orgStudyIdInfo': {'id': 'UP5965-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Isometric handgrip exercise', 'description': 'Small Mass Muscle - isometric handgrip exercise', 'interventionNames': ['Procedure: Isometric handgrip exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Isometric knee extension exerice', 'description': 'Large Mass Muscule - isometric knee extension exercise', 'interventionNames': ['Procedure: Isometric knee extension exercise']}], 'interventions': [{'name': 'Isometric handgrip exercise', 'type': 'PROCEDURE', 'description': 'Participants will train 3 times per week for 4 weeks. Each session will consist of four sets of 2-minute contractions sustained at 30% of maximum voluntary contraction (MVC), performed with a handgrip device for each arm, with 1-minute rest intervals between sets and between arms.', 'armGroupLabels': ['Isometric handgrip exercise']}, {'name': 'Isometric knee extension exercise', 'type': 'PROCEDURE', 'description': 'Participants will train 3 times per week for 4 weeks. Each session will consist of four sets of 2-minute contractions sustained at 30% of maximum voluntary contraction (MVC), performed with adjustable ankle weights for each leg, with 1-minute rest intervals between sets and between legs.', 'armGroupLabels': ['Isometric knee extension exerice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90620-001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Instituto de Cardiologia do Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Alexandre Lehnen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Cardiologia do Rio Grande do Sul'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Cardiologia do Rio Grande do Sul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Patricia Caetano', 'investigatorAffiliation': 'Instituto de Cardiologia do Rio Grande do Sul'}}}}