Comparing Sports Bra Design in Full Busted Women

NCT05456594 | Completed

• 1 other identifier: STUDY00003644
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Pain; Mastalgia; Back Pain; Back Strain; Back Pain, Low; Neck Pain; Chest Pain; Activity, Motor; Aging Well; Weight, Body; Body Image

Outcome Measures

Primary Outcomes (7)

• Biomechanical Data

  Segmental displacement (m)

  1 day

• Biomechanical Data

  Segmental velocity (m/s)

  1 day

• Biomechanical Data

  Segmental acceleration (m/s\^2)

  1 day

• Biomechanical Data

  Gait speed (m/s)

  1 day

• Biomechanical Data

  Cadence (Hz)

  1 day

• Biomechanical Data

  Muscle activity (mV)

  1 day

• Pain Measures

  Qualitative assessment of pain via self report (no units)

  1 day

Secondary Outcomes (7)

• Anthropometry

  1 day

• Anthropometry

  1 day

• Anthropometry

  1 day

• Glycated Hemoglobin

  1 day

• Sex-Hormones

  1 day

Study Arms (3)

Conventional bra

PLACEBO COMPARATOR

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

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.

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.

Other: Conventional bra; Other: Bounceless bra

Interventions

Conventional bra OTHER

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; Shefit bra

Bounceless bra OTHER

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).

Conventional bra; Shefit bra

Shefit bra OTHER

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).

Bounceless bra; Conventional bra

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Houston: lead
• Bounceless: collaborator

Study Sites (1)

University of Houston

Houston, Texas, 77204-6015, United States

Location

Related Links

• Online Screening Form for Potential Participants

MeSH Terms

Conditions

Mastodynia; Back Pain; Low Back Pain; Neck Pain; Chest Pain; Motor Activity; Body Weight

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study involves use of a cross-sectional observation and analysis of behavior using a cross-over approach in assessing 2 sports bra models.

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 13, 2022
• Study Start: June 20, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)