Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-30 @ 5:28 AM
Study NCT ID:
NCT02301559
Status:
UNKNOWN
Last Update Posted:
2014-11-26
First Post:
2014-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of the Method Pilates in Women With Primary Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026241', 'term': 'Exercise Movement Techniques'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2014-11-16', 'studyFirstSubmitQcDate': '2014-11-25', 'lastUpdatePostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain, Visual analog scale', 'timeFrame': 'two months', 'description': 'Effects of pilates method in pain'}, {'measure': 'Quality of health, score Short Form-36', 'timeFrame': 'two months', 'description': 'Effects of pilates method in quality of health'}], 'secondaryOutcomes': [{'measure': 'Flexibility, finger-ground test', 'timeFrame': 'two months', 'description': 'Effects of pilates method in flexibility'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Primary dysmenorrhea is the result of hypercontractility and uterine vascular ischemia is the most common gynecologic complaints in young women. According to the intensity of symptoms may impair daily living, work and leisure activities. Pilates brings the concept of moving the body for the recovery, maintenance and promotion of health through exercises that stimulate circulation, improving physical conditioning, flexibility and proper postural alignment, and promote improvement in the levels of body awareness, coordination and muscle control. In this sense, the objective is to investigate the effects of pilates in the symptomatology of primary dysmenorrhea. This is a study to be developed with students of Physical Therapy from the State University of Piauí-UESPI presenting with primary dysmenorrhea compatible clinical picture. A questionnaire will be used for research. The students with the framework of dysmenorrhea that meet the inclusion criteria will be assessed for anthropometric parameters, pain, flexibility, indirect assessment of contraction of transversus abdominis and quality of life before and after the treatment protocol using the pilates method, often 3 weekly meetings, totaling 20 sessions.', 'detailedDescription': 'The objective is to investigate the effects of pilates in the symptomatology of primary dysmenorrhea. This is a study to be developed with students of Physical Therapy from the State University of Piauí-UESPI presenting with primary dysmenorrhea compatible clinical picture. A questionnaire will be used for research. The students with the framework of dysmenorrhea that meet the inclusion criteria will be assessed for anthropometric parameters, pain, flexibility, indirect assessment of contraction of transversus abdominis and quality of life before and after the treatment protocol using the pilates method, often 3 weekly meetings, totaling 20 sessions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary\n* Female\n* 18-25 years old\n* Enrolled in Physiotherapy course at the State University of Piauí- UESPI, with symptoms compatible with primary, nulliparous dysmenorrhoea, who have regular menstrual cycle and who agree to participate spontaneously in the research, by signing a term of informed consent (Appendix a) in accordance with Resolution 466/2012.\n* Participation in the survey did not veto the use of analgesic or contraceptive by the participants.\n* All are oriented to maintaining the habits of life - food, work and leisure activities, medications - during the exercises\n\nExclusion Criteria:\n\n* Will not be included in the selected research volunteers that do not show symptoms and characteristics consistent with primary dysmenorrhoea according to the questionnaire, and those who accept not participate and / or not signing the consent form sample.\n* As criteria for inclusion are also not chronic back pain, regular physical activity (3 or more times per week), women with pathological picture associated or malformation of the pelvic organs (secondary dysmenorrhea), or those that make use of device Intra- uterus (IUD).\n* Will be excluded from the sample participants who submit two consecutive absences to care.'}, 'identificationModule': {'nctId': 'NCT02301559', 'briefTitle': 'The Influence of the Method Pilates in Women With Primary Dysmenorrhea', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual do PiauÍ'}, 'officialTitle': 'The Influence of the Method Pilates in Life Quality, Intensity of Pain and Flexibility of Women With Primary Dysmenorrhea', 'orgStudyIdInfo': {'id': '04008402357J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilates Group', 'description': 'Pilates Group, Pilates exercises, 20 sessions, lasting 40 minutes each, 3 times per week. Soil and ball exercises, with emphasis on the pelvic region. The program began with the work of breathing and postural correction, with warm-up exercises or preparatory, followed by the framework of classical movements of the method.', 'interventionNames': ['Behavioral: Pilates exercises']}], 'interventions': [{'name': 'Pilates exercises', 'type': 'BEHAVIORAL', 'description': 'Pilates exercises with emphasis on pelvic region', 'armGroupLabels': ['Pilates Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64000000', 'city': 'Teresina', 'state': 'Piauí', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Juliany M A da Fonseca, Principal', 'role': 'CONTACT', 'email': 'juliany.markes@hotmail.com', 'phone': '(86)81644967'}], 'facility': 'Universidade Estadual do Piaui', 'geoPoint': {'lat': -5.08917, 'lon': -42.80194}}], 'centralContacts': [{'name': 'Juliany M A da Fonseca, Principal', 'role': 'CONTACT', 'email': 'juliany.markes@hotmail.com', 'phone': '(86) 81644967'}, {'name': 'Juliany M A da Fonseca, Principal', 'role': 'CONTACT', 'email': 'juliany.markes@hotmail.com', 'phone': '(86)81644967'}], 'overallOfficials': [{'name': 'Juliany M A da Fonseca, Principal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Estadual do PiauÍ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual do PiauÍ', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'academic physiotherapy', 'investigatorFullName': 'Juliany Marques Abreu da Fonseca', 'investigatorAffiliation': 'Universidade Estadual do PiauÍ'}}}}