Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT02458456
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2015-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isometric Handgrip Exercise for Blood Pressure Management
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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-14', 'studyFirstSubmitDate': '2015-05-21', 'studyFirstSubmitQcDate': '2015-05-27', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in systolic and diastolic blood pressure', 'timeFrame': 'Baseline and 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Compare and contrast changes in blood pressure between the 5% maximum voluntary contraction (MVC) and 30% MVC hypertensive groups', 'timeFrame': 'Baseline and 8 weeks'}, {'measure': 'Compare and contrast blood pressure changes between the 30% maximum voluntary contraction (MVC) hypertensive and 30% MVC normotensive groups', 'timeFrame': 'Baseline and 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '24582191', 'type': 'BACKGROUND', 'citation': 'Carlson DJ, Dieberg G, Hess NC, Millar PJ, Smart NA. Isometric exercise training for blood pressure management: a systematic review and meta-analysis. Mayo Clin Proc. 2014 Mar;89(3):327-34. doi: 10.1016/j.mayocp.2013.10.030.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is to conduct a randomised controlled trial to assess the effect of performing isometric exercise using a handgrip dynamometer on blood pressure.', 'detailedDescription': 'Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic exercise for lowering blood pressure. A randomised controlled study will be conducted with participants who are either pre-hypertensive, blood pressure between 120/80 and 140/90, or on medication to control their blood pressure. Previous studies have utilised a sedentary control so we intend to use a sham group to determine if it can be used as a working control for future studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Those within the required age limits, both normotensive, pre-hypertensive, and those medicated for blood pressure management.\n\nExclusion Criteria:\n\n* Younger than 30 years and older than 70 years; those deemed not to have the capacity to voluntarily participate, unable to participate under their doctor's recommendation, or with arthritis or carpal tunnel syndrome who may aggravate their condition with handgrip exercise."}, 'identificationModule': {'nctId': 'NCT02458456', 'briefTitle': 'Isometric Handgrip Exercise for Blood Pressure Management', 'organization': {'class': 'OTHER', 'fullName': 'University of New England, Australia'}, 'officialTitle': 'Isometric Handgrip Exercise for Blood Pressure Management. A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'UNewEngland1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'IHG 5% Hypertensive', 'description': 'Participants who are either un-medicated pre-hypertensive or medicated for blood pressure management conducting isometric resistance training using a hand dynamometer at 5% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks.', 'interventionNames': ['Other: Isometric resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'IHG 30% Hypertensive', 'description': 'Participants who are either un-medicated pre-hypertensive or medicated for blood pressure management conducting isometric resistance training using a hand dynamometer at 30% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks.', 'interventionNames': ['Other: Isometric resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'IHG 30% Normotensive', 'description': 'Participants who are normotensive conducting isometric resistance training using a hand dynamometer at 30% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks.', 'interventionNames': ['Other: Isometric resistance training']}, {'type': 'SHAM_COMPARATOR', 'label': 'IHG 5% Normotensive', 'description': 'Participants who are normotensive conducting isometric resistance training using a hand dynamometer at 5% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks.', 'interventionNames': ['Other: Isometric resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'IHG 10% Hypertensive', 'description': 'Participants who are either un-medicated pre-hypertensive or medicated for blood pressure management conducting isometric resistance training using a hand dynamometer at 10% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks.', 'interventionNames': ['Other: Isometric resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'IHG 10% Normotensive', 'description': 'Participants who are normotensive conducting isometric resistance training using a hand dynamometer at 10% of their maximum voluntary contraction. Participants with perform 4 x 2 minutes isometric handgrip exercises 3 times per week under supervision for 8 weeks.', 'interventionNames': ['Other: Isometric resistance training']}], 'interventions': [{'name': 'Isometric resistance training', 'type': 'OTHER', 'description': 'Isometric exercise using a hand dynamometer.', 'armGroupLabels': ['IHG 10% Hypertensive', 'IHG 10% Normotensive', 'IHG 30% Hypertensive', 'IHG 30% Normotensive', 'IHG 5% Hypertensive', 'IHG 5% Normotensive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2351', 'city': 'Armidale', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'University of New England', 'geoPoint': {'lat': -30.50123, 'lon': 151.66553}}], 'overallOfficials': [{'name': 'Neil Smart, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New England'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New England, Australia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Deb Carlson', 'investigatorAffiliation': 'University of New England'}}}}