- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05456594
Comparing Sports Bra Design in Full Busted Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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/).
Conventional 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.
While 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.
Despite 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/).
Unfortunately, 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.
Recently, 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.
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.
References:
Gibson 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77204-6015
- University of Houston
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to provide informed consent
- Age of 18 to 55 years
- Female sex at birth
- Self-declared breast size of D-G cup (US sizes: D, DD/E, DDD/F, DDDD/G)
- Bra band size between 32-40"
- International Physical Activity Questionnaire - Short Form (IPAQ-SF) score of 3 or higher
- An answer of "NO" to any item of the general health questions of the PARQ+
- No history of surgery to: back, neck, or shoulders
- No history of breast reconstruction
- No history of spinal cord injury (SCI)
Exclusion Criteria:
- Inability to provide informed consent
- Age 17 years old or younger or 56 years or older
- Male sex at birth
k. 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Conventional bra
Measurement of kinematic and kinetic data during physical activities while participant is wearing their own conventional bra.
|
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).
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).
|
Active Comparator: Bounceless bra
Measurement of kinematic and kinetic data during physical activities while participant is wearing provided Bounceless bra.
|
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).
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).
|
Active Comparator: Shefit bra
Measurement of kinematic and kinetic data during physical activities while participant is wearing provided Shefit bra.
|
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).
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomechanical Data
Time Frame: 1 day
|
Segmental displacement (m)
|
1 day
|
Biomechanical Data
Time Frame: 1 day
|
Segmental velocity (m/s)
|
1 day
|
Biomechanical Data
Time Frame: 1 day
|
Segmental acceleration (m/s^2)
|
1 day
|
Biomechanical Data
Time Frame: 1 day
|
Gait speed (m/s)
|
1 day
|
Biomechanical Data
Time Frame: 1 day
|
Cadence (Hz)
|
1 day
|
Biomechanical Data
Time Frame: 1 day
|
Muscle activity (mV)
|
1 day
|
Pain Measures
Time Frame: 1 day
|
Qualitative assessment of pain via self report (no units)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometry
Time Frame: 1 day
|
Height (m)
|
1 day
|
Anthropometry
Time Frame: 1 day
|
Mass (kg)
|
1 day
|
Anthropometry
Time Frame: 1 day
|
Percent body fat (%)
|
1 day
|
Glycated Hemoglobin
Time Frame: 1 day
|
A1c (%)
|
1 day
|
Sex-Hormones
Time Frame: 1 day
|
Estrone (mg/dL)
|
1 day
|
Sex-Hormones
Time Frame: 1 day
|
Estradiol (mg/dL)
|
1 day
|
Sex-Hormones
Time Frame: 1 day
|
Testosterone (mg/dL)
|
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003644
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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