Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-18 @ 12:48 AM
Study NCT ID:
NCT03757169
Status:
UNKNOWN
Last Update Posted:
2018-11-30
First Post:
2018-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two randomized groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2018-11-21', 'studyFirstSubmitQcDate': '2018-11-27', 'lastUpdatePostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change at ambulatory blood pressure monitoring', 'timeFrame': 'Change from the baseline ambulatory blood pressure monitoring at 12 weeks', 'description': '24h of monitoring blood pressure'}], 'secondaryOutcomes': [{'measure': 'Change at blood pressure', 'timeFrame': 'Change from the baseline brachial blood pressure at 12 weeks', 'description': 'Three measurement of brachial blood pressure'}, {'measure': 'Chance at Apnea-Hypopnea Index (AHI)', 'timeFrame': 'Change from the baseline AHI at 12 weeks', 'description': 'Index obtained by the Polysomnography to detect the level of Apnea-Hypopnea Index. The higher level, the worse the disease. The value of the AHI between 5 to 15 events/hour means mild disease. AHI between 16 to 30 events/hour means moderate disease, and more than 30 events/hour means severe disease.'}, {'measure': 'Change at Pulse wave velocity', 'timeFrame': 'Change from the baseline pulse wave velocity at 12 weeks', 'description': 'To evaluate the pulse wave velocity (femoral, carotid and aortic) to detect the occurrence of arterial disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['training', 'hand grip', 'exercise'], 'conditions': ['Obstructive Sleep Apnea', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) is a common clinical condition, involving the development of arterial hypertension. A Meta analysis study have shown that isometric hand grip training promotes blood pressure reduction. It is going to be conducted a clinical trail to determine the effects of hand grip training in OSA patients to change the arterial hypertension.', 'detailedDescription': 'Background: obstructive sleep apnea (OSA) is a common clinical condition, involving the development of arterial hypertension. Meta analysis study have shown that isometric hand grip strength promotes blood pressure reduction, and its reduction is higher than that observed after aerobic training. Objective: to analyze the effects of the isometric hand grip on blood pressure changes of patients with uncontrolled arterial hypertension with OSA. Methods: a randomized controlled trial involving 18 adults with OSA and uncontrolled arterial hypertension of both sexes, randomized between control group (receive general guidelines) and hand grip group. 12 weeks of training with load equivalent to 30% of maximum voluntary capacity was performed. All participants will be submitted for evaluation of blood pressure (BP) central and brachial, pulse wave velocity, full polysomnography,before and after the study protocol (the change from the baseline at 12 weeks). Expected results: the authors believe that hand grip training can change (reduce) blood pressure in patient with OSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OSA diagnose based on polysomnography,\n* Apnea-Hypopnea Index (AHI) \\> 5,\n* arterial hypertension (systolic arterial pressure \\> 140 mmHg or diastolic arterial pressure \\> 90 mmHg)\n\nExclusion Criteria:\n\n* other heart disease'}, 'identificationModule': {'nctId': 'NCT03757169', 'acronym': 'OSA', 'briefTitle': 'Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pernambuco'}, 'officialTitle': 'Effect of Isometric Hand Grip Training on Blood Pressure of Hypertensive Patients With Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'isopress03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Verbal informations about the disease, and exercise behavior, and nutrition.', 'interventionNames': ['Other: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hand grip group', 'description': 'Three supervised sessions por week: 4 series (2 at each arm) of two minutes of isometric hand grip contraction at 30% of maximal voluntary contraction. Between series there will be two minutes to rest.', 'interventionNames': ['Other: Hand grip isometric contraction']}], 'interventions': [{'name': 'Hand grip isometric contraction', 'type': 'OTHER', 'description': 'The patients at the Hand Grip group will perform 12 weeks of hand grip exercises, three times/week for 16 minutes with time to rest.', 'armGroupLabels': ['Hand grip group']}, {'name': 'Control', 'type': 'OTHER', 'description': 'The patients will receive verbal orientations about the OSA and the arterial hypertension.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50.100-060', 'city': 'Recife', 'state': 'Pernambuco', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Rodrigo Pedrosa, PhD', 'role': 'CONTACT', 'email': 'rppedrosa@terra.com.br', 'phone': '+55 81 31817179'}, {'name': 'Flávio MD Andrade, Ms', 'role': 'CONTACT', 'phone': '+ 55 81 99635 54 17'}], 'facility': 'Pronto Socorro Cardiológico de Pernambuco - Procape', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}], 'centralContacts': [{'name': 'Flávio MD Andrade, Ms', 'role': 'CONTACT', 'email': 'flaviomacielandrade@yahoo.com.br', 'phone': '+55 81 99635 5417'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pernambuco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of sleep laboratory and heart emergency room of Pernambuco , Principal Investigator.', 'investigatorFullName': 'Rodrigo Pinto Pedrosa', 'investigatorAffiliation': 'University of Pernambuco'}}}}