Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT02215668
Status:
UNKNOWN
Last Update Posted:
2014-08-13
First Post:
2014-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Physical Exercise in Reducing Pain in Women Undergoing Mammography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-02-01', 'releaseDate': '2015-12-21'}, {'resetDate': '2016-02-29', 'releaseDate': '2016-02-01'}, {'resetDate': '2016-06-16', 'releaseDate': '2016-05-10'}, {'resetDate': '2016-07-29', 'releaseDate': '2016-06-20'}, {'resetDate': '2016-09-23', 'releaseDate': '2016-08-02'}], 'estimatedResultsFirstSubmitDate': '2015-12-21'}}, '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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-11', 'studyFirstSubmitDate': '2014-08-09', 'studyFirstSubmitQcDate': '2014-08-11', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased pain after mammography.', 'timeFrame': 'Decrease in pain after performing mammography, checked10 minutes after the procedure e, measured by visual analog scale.', 'description': 'Following the randomization, approximately 10 minutes after performing a physical exercise in the upper limbs (Group 1) and lower (Group 2), or not performing any physical exercise (Group 0), the woman will be submitted to bilateral mammogram. Ten minutes after the procedure, the assessment of pain during mammography will be measured by the visual analog scale. The mean difference between the measurements of visual analog scale (VAS) will be compared between groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain', 'Side Effects']}, 'descriptionModule': {'briefSummary': 'Mammography is a systematic way in the main programs of screening for breast cancer in women over 40 or 50 years old, according to screening programs, but most research has shown a frequency of discomfort and pain during the examination mammography. This study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. It is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination.', 'detailedDescription': 'This research aims to evaluate the relationship of pre-mammography guided physical activity and pain after the examination, evaluating the impact of the intervention in a group of patients undergoing upper limb exercise (SLE), compared to another group women not subject exposure (MNE), and another group with lower limb exercise (LLE). This study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. It is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination. The results will be checked by study association between the level of physical activity, body mass index, breast density and reducing the pain effect between groups for comparison of means and variances of values of the visual analogue scale (VAS).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women: 20 to 69 years old\n\nExclusion Criteria:\n\n* Cardiovascular disease\n* Mental diseases\n* Pulmonary diseases\n* Steroids use'}, 'identificationModule': {'nctId': 'NCT02215668', 'briefTitle': 'The Effect of Physical Exercise in Reducing Pain in Women Undergoing Mammography', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Impact of Physical Exercise, Aimed at Reducing Pain in Women Who Underwent Mammography.', 'orgStudyIdInfo': {'id': '313.907'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No physical exercise', 'description': 'Women are never subjected to any exercise prior to mammography.'}, {'type': 'EXPERIMENTAL', 'label': 'Physical exercise (Upper limb)', 'description': 'Women will be subjected to physical exercise on upper limb prior to mammography.', 'interventionNames': ['Procedure: Physical exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Women are subjected to physical exercise in the lower limbs prior to mammography', 'interventionNames': ['Procedure: Physical exercise']}], 'interventions': [{'name': 'Physical exercise', 'type': 'PROCEDURE', 'otherNames': ['Physical activity'], 'description': 'Exercise muscle stretching and body warming.', 'armGroupLabels': ['Group 2', 'Physical exercise (Upper limb)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14780000', 'city': 'Barretos', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Altacilio A Nunes, MD; Ph,D', 'role': 'CONTACT', 'email': 'altacilio@fmrp.usp.br', 'phone': '+551636022884'}, {'name': 'Tadeu', 'role': 'CONTACT'}, {'name': 'Tadeu Cardoso, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital do Cancer de Barretos', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}], 'centralContacts': [{'name': 'Altacilio A Nunes, Ph.D', 'role': 'CONTACT', 'email': 'altacilio@fmrp.usp.br', 'phone': '+551636022884'}, {'name': 'Tadeu Cardoso, MSc', 'role': 'CONTACT', 'email': 'tadeucardoso@hotmail.com', 'phone': '+5517981132313'}], 'overallOfficials': [{'name': 'Altacilio A Nunes, MD; Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ribeirao Preto Medical School - USP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full professor; MD; Ph.D.', 'investigatorFullName': 'Altacílio Aparecido Nunes', 'investigatorAffiliation': 'University of Sao Paulo'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-12-21', 'type': 'RELEASE'}, {'date': '2016-02-01', 'type': 'RESET'}, {'date': '2016-02-01', 'type': 'RELEASE'}, {'date': '2016-02-29', 'type': 'RESET'}, {'date': '2016-05-10', 'type': 'RELEASE'}, {'date': '2016-06-16', 'type': 'RESET'}, {'date': '2016-06-20', 'type': 'RELEASE'}, {'date': '2016-07-29', 'type': 'RESET'}, {'date': '2016-08-02', 'type': 'RELEASE'}, {'date': '2016-09-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Altacílio Aparecido Nunes, Full professor; MD; Ph.D., University of Sao Paulo'}}}}