Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-09 @ 2:44 PM
Study NCT ID:
NCT05456594
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2022-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Sports Bra Design in Full Busted Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059373', 'term': 'Mastodynia'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study involves use of a cross-sectional observation and analysis of behavior using a cross-over approach in assessing 2 sports bra models.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomechanical Data', 'timeFrame': '1 day', 'description': 'Segmental displacement (m)'}, {'measure': 'Biomechanical Data', 'timeFrame': '1 day', 'description': 'Segmental velocity (m/s)'}, {'measure': 'Biomechanical Data', 'timeFrame': '1 day', 'description': 'Segmental acceleration (m/s\\^2)'}, {'measure': 'Biomechanical Data', 'timeFrame': '1 day', 'description': 'Gait speed (m/s)'}, {'measure': 'Biomechanical Data', 'timeFrame': '1 day', 'description': 'Cadence (Hz)'}, {'measure': 'Biomechanical Data', 'timeFrame': '1 day', 'description': 'Muscle activity (mV)'}, {'measure': 'Pain Measures', 'timeFrame': '1 day', 'description': 'Qualitative assessment of pain via self report (no units)'}], 'secondaryOutcomes': [{'measure': 'Anthropometry', 'timeFrame': '1 day', 'description': 'Height (m)'}, {'measure': 'Anthropometry', 'timeFrame': '1 day', 'description': 'Mass (kg)'}, {'measure': 'Anthropometry', 'timeFrame': '1 day', 'description': 'Percent body fat (%)'}, {'measure': 'Glycated Hemoglobin', 'timeFrame': '1 day', 'description': 'A1c (%)'}, {'measure': 'Sex-Hormones', 'timeFrame': '1 day', 'description': 'Estrone (mg/dL)'}, {'measure': 'Sex-Hormones', 'timeFrame': '1 day', 'description': 'Estradiol (mg/dL)'}, {'measure': 'Sex-Hormones', 'timeFrame': '1 day', 'description': 'Testosterone (mg/dL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Pain', 'Mastalgia', 'Back Pain', 'Back Strain', 'Back Pain, Low', 'Neck Pain', 'Chest Pain', 'Activity, Motor', 'Aging Well', 'Weight, Body', 'Body Image']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://universityofhouston.iad1.qualtrics.com/jfe/form/SV_9M6NXHOFjYLm38G', 'label': 'Online Screening Form for Potential Participants'}]}, 'descriptionModule': {'briefSummary': 'The goal of the current project is to assess performance of the Bounceless Control sports bra versus: (1) the Shefit Ultimate Sports bra, and (2) conventional bra as worn by participants in a variety of athletic activities.', 'detailedDescription': 'Research has shown that during activities such as running and jumping, bare breasts move up and down as much as 12 cm. This is due to insufficient anatomical support within the breasts (https://sma.org.au/resources-advice/injury-fact-sheets/exercise-and-breast-support/).\n\nConventional bras do not provide enough breast support during athletic activities. Additionally, dynamic breast movement induces motion/slippage of conventional bra straps, skin chaffing due to friction, and skin irritation/abrasion/soreness due to impression of metal fixtures (e.g., hooks, underwires, etc.) within the bras. In response to the inadequacies of conventional bras, the first sports bras were invented in 1977. The sports bra (originally known as the "Jogbra") is considered a groundbreaking item which helped remove a major barrier to women\'s participation in athletic activities. The original Jogbra was created by sewing 2 mens athletic supports together.\n\nWhile the design of Jogbra was simple in its original form, updates to modern materials and sewing techniques over the past 45 years has spawned a wide variety of sports bras that are available worldwide. Modern sports bras vary in materials and construction techniques. These features dictate the sizes available for the bras was well as recommended uses for the bras. Most commercially available sport bras are designed for low to medium impact activities in sizes ranging from extra small (US bra size 32A) to extra large (40C). The design of most of these sports bras are similar to the original Jogbra design.\n\nDespite the availability of sports bras in many sizes, materials, and constructions, women with larger breasts (cup sizes C+) still experience excessive breast movement during exercise, even while wearing a sports bra. Such movement is uncomfortable and may be embarrassing. Both breast discomfort and embarrassment are recognized as significant barriers to physical activity in women. Women with larger breast sizes thus require greater support from their sports bra (https://sma.org.au/resources-advice/injury-fact-sheets/exercise-and-breast-support/).\n\nUnfortunately, due to the commercial desire to keep costs as low as possible in production of sports bras, the materials and designs used in most sports bras remain inadequate for women with larger breast sizes. In many cases, women with larger breast continue to wear a conventional bra underneath a sports bra or 2 sports bras together for increased breast support during athletic activities.\n\nRecently, 2 companies (Shefit and Bounceless) have attempted to address this issue in the marketplace. Shefit is the larger of the 2 companies working to offer more supportive sports bra options. A recent study of sports bra performance in women with breast sizes ranging from AA-DD found that the Shefit Ultimate Sports bra performed similar to other sports bras offered by large manufacturers of athletic equipment (e.g., Nike, Underarmor) (Gibson et al. 2019). The Bounceless project was omitted from such testing. The Bounceless Control sports bra offers additional support beyond the Shefit Ultimate Sports bra as it is a long line (additional fabric that extends below the bust) sports bra with an internal breast band to support breasts during activity while also preventing multidirectional accelerations of breast material during activity.\n\nThe goal of the current project is to assess performance of the Bounceless Control sports bra versus: (1) the Shefit Ultimate Sports bra, and (2) conventional bra as worn by participants in a variety of athletic activities.\n\nReferences:\n\nGibson TM, Balendra N, Ustinova KI, Langenderfer JE. Reductions in Kinematics from Brassieres with Varying Breast Support. International Journal of Exercise Science. 2019;12(1):402-411.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to provide informed consent\n2. Age of 18 to 55 years\n3. Female sex at birth\n4. Self-declared breast size of D-G cup (US sizes: D, DD/E, DDD/F, DDDD/G)\n5. Bra band size between 32-40"\n6. International Physical Activity Questionnaire - Short Form (IPAQ-SF) score of 3 or higher\n7. An answer of "NO" to any item of the general health questions of the PARQ+\n8. No history of surgery to: back, neck, or shoulders\n9. No history of breast reconstruction\n10. No history of spinal cord injury (SCI)\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Age 17 years old or younger or 56 years or older\n3. Male sex at birth\n\nk. Self-declared breast size of smaller than D cup or larger than G cup (US sizes) d. Bra band size outside of the range 32-40" e. IPAQ-SF score of 2 or lower f. An answer of "YES" to any item of the general health questions of the PARQ+ g. Diagnosis of Type I Diabetes, Diagnosis of Type II Diabetes, Type III Diabetes, Latent Autoimunne diabetes in adults (LADA), or current Gestational Diabetes h. History of limb amputation (upper or lower extremity) i. Presence of open pressure sores on the upper or lower extremities j. History of breast augmentation, reconstruction, or mastectomy k. Currently pregnant or lactating/breastfeeding l. History of surgery to: back, neck, or shoulders m. History of the following neurological diseases: Cerebrovascular accident (CVA, stroke), Alzheimer\'s Disease (AD), Dementia (of any form), Huntington\'s Disease, Traumatic Brain Injury (TBI), Spinal cord injury (SCI), Multiple Sclerosis (MS), Parkinson\'s Disease (PD), Polio, Paraproteinaemic Demyelinating Neuropathy (PDN) and/or Monoclonal Gammopathy of Undetermined Significance (MGUS), Myasthenia Gravis, Muscular Dystrophy, Rheumatoid Arthritis, Guillain-Barré Syndrome, Charcot-Marie-Tooth Disorder or other hereditary neuropathies, or pain in the extremities (shoulder, elbows, wrist, fingers, hips, knees, ankles, or feet) that severely limit activities of daily living.'}, 'identificationModule': {'nctId': 'NCT05456594', 'briefTitle': 'Comparing Sports Bra Design in Full Busted Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Comparing Sports Bra Design in Full Busted Women', 'orgStudyIdInfo': {'id': 'STUDY00003644'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional bra', 'description': 'Measurement of kinematic and kinetic data during physical activities while participant is wearing their own conventional bra.', 'interventionNames': ['Other: Bounceless bra', 'Other: Shefit bra']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bounceless bra', 'description': 'Measurement of kinematic and kinetic data during physical activities while participant is wearing provided Bounceless bra.', 'interventionNames': ['Other: Conventional bra', 'Other: Shefit bra']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Shefit bra', 'description': 'Measurement of kinematic and kinetic data during physical activities while participant is wearing provided Shefit bra.', 'interventionNames': ['Other: Conventional bra', 'Other: Bounceless bra']}], 'interventions': [{'name': 'Conventional bra', 'type': 'OTHER', 'description': 'This study involves use of a cross-sectional observation and analysis of behavior using a cross-over approach in assessing breast motion while using a conventional bra (bra condition #1).', 'armGroupLabels': ['Bounceless bra', 'Shefit bra']}, {'name': 'Bounceless bra', 'type': 'OTHER', 'description': 'This study involves use of a cross-sectional observation and analysis of behavior using a cross-over approach in assessing breast motion while using a provided Bounceless bra (bra condition #2a).', 'armGroupLabels': ['Conventional bra', 'Shefit bra']}, {'name': 'Shefit bra', 'type': 'OTHER', 'description': 'This study involves use of a cross-sectional observation and analysis of behavior using a cross-over approach in assessing breast motion while using a provided Shefit bra (bra condition #2b).', 'armGroupLabels': ['Bounceless bra', 'Conventional bra']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204-6015', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bounceless', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stacey Gorniak', 'investigatorAffiliation': 'University of Houston'}}}}