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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05456594
Other study ID # STUDY00003644
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 20, 2022
Est. completion date January 31, 2023

Study information

Verified date November 2023
Source University of Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date January 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. Able to provide informed consent 2. Age of 18 to 55 years 3. Female sex at birth 4. Self-declared breast size of D-G cup (US sizes: D, DD/E, DDD/F, DDDD/G) 5. Bra band size between 32-40" 6. International Physical Activity Questionnaire - Short Form (IPAQ-SF) score of 3 or higher 7. An answer of "NO" to any item of the general health questions of the PARQ+ 8. No history of surgery to: back, neck, or shoulders 9. No history of breast reconstruction 10. No history of spinal cord injury (SCI) Exclusion Criteria: 1. Inability to provide informed consent 2. Age 17 years old or younger or 56 years or older 3. 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 Design


Intervention

Other:
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 conventional bra (bra condition #1).
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 Bounceless bra (bra condition #2a).
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 Shefit bra (bra condition #2b).

Locations

Country Name City State
United States University of Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Houston Bounceless

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biomechanical Data Segmental displacement (m) 1 day
Primary Biomechanical Data Segmental velocity (m/s) 1 day
Primary Biomechanical Data Segmental acceleration (m/s^2) 1 day
Primary Biomechanical Data Gait speed (m/s) 1 day
Primary Biomechanical Data Cadence (Hz) 1 day
Primary Biomechanical Data Muscle activity (mV) 1 day
Primary Pain Measures Qualitative assessment of pain via self report (no units) 1 day
Secondary Anthropometry Height (m) 1 day
Secondary Anthropometry Mass (kg) 1 day
Secondary Anthropometry Percent body fat (%) 1 day
Secondary Glycated Hemoglobin A1c (%) 1 day
Secondary Sex-Hormones Estrone (mg/dL) 1 day
Secondary Sex-Hormones Estradiol (mg/dL) 1 day
Secondary Sex-Hormones Testosterone (mg/dL) 1 day
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