Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-29 @ 9:44 PM
Study NCT ID:
NCT02118350
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2014-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Mat Pilates Training on Blood Pressure of Hypertensive Individuals
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-16', 'studyFirstSubmitDate': '2014-04-16', 'studyFirstSubmitQcDate': '2014-04-16', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '16 weeks', 'description': 'Blood pressure was measured by Ambulatorial Monitoring Blood Pressure before and after trial period and by semiautomatic monitoring before and after a single session of Mat Pilates exercise.'}], 'secondaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': '16 weeks', 'description': 'Heart Rate was measured by Ambulatorial Monitoring Blood Pressure before and after trial period and by semiautomatic monitoring before and after a single session of Mat Pilates exercise.'}, {'measure': 'Anxiety', 'timeFrame': '16 weeks.', 'description': 'Anxiety was analyzed by State-Trait Anxiety Inventory (STAI), before and after trial period.'}, {'measure': 'Stress', 'timeFrame': '16 weeks', 'description': 'Stress was analysed by perceived stress questionnaire, before and after trial period.'}, {'measure': 'Depression', 'timeFrame': '16 weeks', 'description': "Depression was analysed by Beck's Depression Inventory (BDI), before and after trial period."}, {'measure': 'Sleep quality', 'timeFrame': '16 weeks', 'description': 'Sleep quality was analysed by The Pittsburgh Sleep Quality Index (PSQI), before and after trial period.'}, {'measure': 'Perception of Sleep', 'timeFrame': '16 weeks', 'description': 'Perception of Sleep was analysed by Mini Sleep Questionnaire, before and after trial period.'}, {'measure': 'Sleepiness', 'timeFrame': '16 weeks', 'description': 'Sleepiness was analysed by Epworth Sleepiness Scale, before and after trial period.'}, {'measure': 'Quality of Life', 'timeFrame': '16 weeks', 'description': 'Quality of Life was analysed by Questionnaire for Health-Related Quality of Life assessment of hypertensive patients, before and after trial period.'}, {'measure': 'Flexibility', 'timeFrame': '16 weeks', 'description': 'Flexibility was analysed by Bank of wells, before and after trial period.'}, {'measure': 'Strength', 'timeFrame': '16 weeks', 'description': 'Strength was analysed by hydraulic handgrip dynamometer, before and after trial period.'}, {'measure': 'Body weight', 'timeFrame': '16 weeks'}, {'measure': 'Height', 'timeFrame': '16 weeks'}, {'measure': 'Waist circumference', 'timeFrame': '16 weeks'}, {'measure': 'Hip circumference', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The study aimed to evaluate the chronic effects of Mat Pilates Training on blood pressure, heart rate, double product and psychobiological factors in hypertensive medicated women and acute effects of Mat Pilates Exercise on blood pressure of such individuals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertensives women\n* Age 30 to 59 years\n* Nonactive\n* Make use of antihypertensive medication\n\nExclusion Criteria:\n\n* Orthopedic problems or other problem that prevented the exercises\n* Change in drug treatment during protocol\n* Absence in more than 25% of the exercise sessions'}, 'identificationModule': {'nctId': 'NCT02118350', 'briefTitle': 'Effect of Mat Pilates Training on Blood Pressure of Hypertensive Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effect of Mat Pilates Training on Blood Pressure of Hypertensive Individuals', 'orgStudyIdInfo': {'id': 'Pilates'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mat Pilates training', 'description': 'Mat Pilates training performed two times at week for 16 weeks.', 'interventionNames': ['Behavioral: Mat Pilates Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Mat Pilates Training', 'type': 'BEHAVIORAL', 'description': 'Mat Pilates training performed two times at week for 16 weeks.', 'armGroupLabels': ['Mat Pilates training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11060-001', 'city': 'Santos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University of Sao Paulo', 'geoPoint': {'lat': -23.96083, 'lon': -46.33361}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Alessandra Medeiros', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}