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Clinical Trials/NCT05456594
NCT05456594CompletedNot Applicable

Comparing Sports Bra Design in Full Busted Women

University of Houston2 sites in 1 country33 target enrollmentStarted: June 20, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Locations
2
Primary Endpoint
Pain Measures

Study Overview

Brief 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.

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Pain Measures

Time Frame: 1 day

Qualitative assessment of pain via self report (no units)

Biomechanical Data

Time Frame: 1 day

Segmental displacement (m)

Secondary Outcomes

  • Glycated Hemoglobin(1 day)
  • Anthropometry(1 day)
  • Sex-Hormones(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stacey Gorniak

Associate Professor

University of Houston

Study Sites (2)

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