Breast PainNCT05456594
Comparing Sports Bra Design in Full Busted Women
A study testing Conventional bra, Bounceless bra and Shefit bra in people with Breast Pain and Mastalgia, run by University of Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Pain, Mastalgia, Back Pain
- What is being tested?
- Conventional bra, Bounceless bra and Shefit bra
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- Inability to provide informed consent
- Age 17 years old or younger or 56 years or older
- Male sex at birth
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Pain, Mastalgia, Back Pain, Back Strain, Back Pain, Low, Neck Pain
- Being tested
- Conventional bra, Bounceless bra, Shefit bra
- Medical subject headings
- Mastodynia, Back Pain, Low Back Pain, Neck Pain, Chest Pain, Motor Activity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional braOther
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 braOther
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 braOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Conventional bra | Placebo comparator | Measurement of kinematic and kinetic data during physical activities while participant is wearing their own conventional bra. Receives: Other: Bounceless bra; Other: Shefit bra |
| Bounceless bra | Active comparator | Measurement of kinematic and kinetic data during physical activities while participant is wearing provided Bounceless bra. Receives: Other: Conventional bra; Other: Shefit bra |
| Shefit bra | Active comparator | Measurement of kinematic and kinetic data during physical activities while participant is wearing provided Shefit bra. Receives: Other: Conventional bra; Other: Bounceless bra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanical Data
Segmental displacement (m)
Measured: 1 day
Biomechanical Data
Segmental velocity (m/s)
Measured: 1 day
Biomechanical Data
Segmental acceleration (m/s^2)
Measured: 1 day
Biomechanical Data
Gait speed (m/s)
Measured: 1 day
Biomechanical Data
Cadence (Hz)
Measured: 1 day
Biomechanical Data
Muscle activity (mV)
Measured: 1 day
Pain Measures
Qualitative assessment of pain via self report (no units)
Measured: 1 day
Secondary outcomes (7)
Anthropometry
Height (m)
Measured: 1 day
Anthropometry
Mass (kg)
Measured: 1 day
Anthropometry
Percent body fat (%)
Measured: 1 day
Glycated Hemoglobin
A1c (%)
Measured: 1 day
Sex-Hormones
Estrone (mg/dL)
Measured: 1 day
Sex-Hormones
Estradiol (mg/dL)
Measured: 1 day
Sex-Hormones
Testosterone (mg/dL)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start20 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Bounceless
- Responsible party
- Principal investigator, Stacey Gorniak, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456594
- Sponsor's protocol ID
- STUDY00003644
- Status last verified
- Nov 2023
- First submitted
- 29 Jun 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Sports Bra Design in Full Busted Women
- ClinicalTrials.gov ID
- NCT05456594
- Acronym / sponsor ID
- STUDY00003644
- Conditions
- Breast Pain, Mastalgia, Back Pain, Back Strain, Back Pain, Low, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- Bounceless
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional bra | Placebo comparator | Other: Bounceless bra, Other: Shefit braMeasurement of kinematic and kinetic data during physical activities while participant is wearing their own conventional bra. |
| Bounceless bra | Active comparator | Other: Conventional bra, Other: Shefit braMeasurement of kinematic and kinetic data during physical activities while participant is wearing provided Bounceless bra. |
| Shefit bra | Active comparator | Other: Conventional bra, Other: Bounceless braMeasurement of kinematic and kinetic data during physical activities while participant is wearing provided Shefit bra. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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"
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Age 17 years old or younger or 56 years or older
- Male sex at birth
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional braThis 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). | Other | Bounceless bra, Shefit bra |
| Bounceless braThis 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). | Other | Conventional bra, Shefit bra |
| Shefit braThis 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). | Other | Bounceless bra, Conventional bra |
Primary outcome
Biomechanical Data
Time frame: 1 day
Segmental displacement (m)
Biomechanical Data
Time frame: 1 day
Segmental velocity (m/s)
Biomechanical Data
Time frame: 1 day
Segmental acceleration (m/s^2)
Biomechanical Data
Time frame: 1 day
Gait speed (m/s)
Biomechanical Data
Time frame: 1 day
Cadence (Hz)
Biomechanical Data
Time frame: 1 day
Muscle activity (mV)
Pain Measures
Time frame: 1 day
Qualitative assessment of pain via self report (no units)
7 secondary outcomes
Anthropometry
Time frame: 1 day
Anthropometry
Time frame: 1 day
Anthropometry
Time frame: 1 day
Glycated Hemoglobin
Time frame: 1 day
Sex-Hormones
Time frame: 1 day
Sex-Hormones
Time frame: 1 day
Sex-Hormones
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Online Screening Form for Potential ParticipantsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional bra, Bounceless bra and Shefit bra in people with Breast Pain and Mastalgia, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomechanical Data (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.