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Comparing Sports Bra Design in Full Busted Women

Primary Purpose

Breast Pain, Mastalgia, Back Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventional bra
Bounceless bra
Shefit bra
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Pain

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Conventional bra

Bounceless bra

Shefit bra

Arm Description

Measurement of kinematic and kinetic data during physical activities while participant is wearing their own conventional bra.

Measurement of kinematic and kinetic data during physical activities while participant is wearing provided Bounceless bra.

Measurement of kinematic and kinetic data during physical activities while participant is wearing provided Shefit bra.

Outcomes

Primary Outcome Measures

Biomechanical Data
Segmental displacement (m)
Biomechanical Data
Segmental velocity (m/s)
Biomechanical Data
Segmental acceleration (m/s^2)
Biomechanical Data
Gait speed (m/s)
Biomechanical Data
Cadence (Hz)
Biomechanical Data
Muscle activity (mV)
Pain Measures
Qualitative assessment of pain via self report (no units)

Secondary Outcome Measures

Anthropometry
Height (m)
Anthropometry
Mass (kg)
Anthropometry
Percent body fat (%)
Glycated Hemoglobin
A1c (%)
Sex-Hormones
Estrone (mg/dL)
Sex-Hormones
Estradiol (mg/dL)
Sex-Hormones
Testosterone (mg/dL)

Full Information

First Posted
June 29, 2022
Last Updated
November 22, 2022
Sponsor
University of Houston
Collaborators
Bounceless
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1. Study Identification

Unique Protocol Identification Number
NCT05456594
Brief Title
Comparing Sports Bra Design in Full Busted Women
Official Title
Comparing Sports Bra Design in Full Busted Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
Bounceless

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Pain, Mastalgia, Back Pain, Back Strain, Back Pain, Low, Neck Pain, Chest Pain, Activity, Motor, Aging Well, Weight, Body, Body Image

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study involves use of a cross-sectional observation and analysis of behavior using a cross-over approach in assessing 2 sports bra models.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional bra
Arm Type
Placebo Comparator
Arm Description
Measurement of kinematic and kinetic data during physical activities while participant is wearing their own conventional bra.
Arm Title
Bounceless bra
Arm Type
Active Comparator
Arm Description
Measurement of kinematic and kinetic data during physical activities while participant is wearing provided Bounceless bra.
Arm Title
Shefit bra
Arm Type
Active Comparator
Arm Description
Measurement of kinematic and kinetic data during physical activities while participant is wearing provided Shefit bra.
Intervention Type
Other
Intervention Name(s)
Conventional bra
Intervention 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).
Intervention Type
Other
Intervention Name(s)
Bounceless bra
Intervention 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).
Intervention Type
Other
Intervention Name(s)
Shefit bra
Intervention 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).
Primary Outcome Measure Information:
Title
Biomechanical Data
Description
Segmental displacement (m)
Time Frame
1 day
Title
Biomechanical Data
Description
Segmental velocity (m/s)
Time Frame
1 day
Title
Biomechanical Data
Description
Segmental acceleration (m/s^2)
Time Frame
1 day
Title
Biomechanical Data
Description
Gait speed (m/s)
Time Frame
1 day
Title
Biomechanical Data
Description
Cadence (Hz)
Time Frame
1 day
Title
Biomechanical Data
Description
Muscle activity (mV)
Time Frame
1 day
Title
Pain Measures
Description
Qualitative assessment of pain via self report (no units)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Anthropometry
Description
Height (m)
Time Frame
1 day
Title
Anthropometry
Description
Mass (kg)
Time Frame
1 day
Title
Anthropometry
Description
Percent body fat (%)
Time Frame
1 day
Title
Glycated Hemoglobin
Description
A1c (%)
Time Frame
1 day
Title
Sex-Hormones
Description
Estrone (mg/dL)
Time Frame
1 day
Title
Sex-Hormones
Description
Estradiol (mg/dL)
Time Frame
1 day
Title
Sex-Hormones
Description
Testosterone (mg/dL)
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204-6015
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://universityofhouston.iad1.qualtrics.com/jfe/form/SV_9M6NXHOFjYLm38G
Description
Online Screening Form for Potential Participants

Learn more about this trial

Comparing Sports Bra Design in Full Busted Women

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