Hormones, Outcomes, and Pain Pathways in Exercise Study
Part of paid clinical trials in Houston, Texas.
- Sponsor
- University of Houston
- Study ID
- NCT07579182
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Activity, Motor
- Back Pain
- Back Pain, Low
- Breast Pain
- Chest Pain
- Gonadal Steroid Hormones
- Healthy Aging
- Inflammation
- Mastalgia
- Neck Pain
- Neuromuscular Manifestations
- Neuronal Plasticity
- Weight, Body
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Accepted
Interventions
- Interventional Sports bra — OTHERThis study involves use of observation and analysis of behavior in assessing breast motion and associated health outcomes while using a provided interventional sports bra of participant choice (Bounceless bra or Shefit Ultimate bra) for 3 months.
Study Details
The goal of the proposed project is to evaluate a mechanical intervention (sports bras designed specifically for full busted women) to alleviate neck, shoulder, arm, and back pain in full-busted women and investigate the contribution of non-mechanical pathways associated with this type of pain in women. Specifically, the investigators will investigate how sex-hormones, inflammation, and remapping of specific regions of the brain contribute to the manifestation of neck, shoulder, arm, and back pain in full-busted women across the lifespan.
Key Dates
- Start date
- May 17, 2026
- Status verified
- May 2026
- Primary completion
- Jun 30, 2029
- Completion
- Sep 30, 2029
Study Design
- Enrollment
- 140 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- No Intervention: ControlWomen with bra cup sizes A - C. Control group will undergo measurement of kinematic and kinetic data during physical activities at baseline. Study questionnaires, pain measures, body composition, brain activity, and blood-based biomarkers will be collected at baseline. Physical activity will be tracked via smartwatch for 3 months after baseline.
- Experimental: Interventional Sports BraWomen with bra cup sizes D - I. Intervention group will undergo measurement of kinematic and kinetic data during physical activities at baseline and 3 months after receiving their interventional sports bras. Study questionnaires, pain measures, body composition, brain activity, and blood-based biomarkers will be collected at baseline and 3 months after receiving the interventional sports bras. Physical activity will be tracked via smartwatch for 3 months after baseline.
Primary Outcome Measure
Pain Measures [ Time Frame: Baseline and 3 months after baseline ]
Central Contacts
- Stacey L Gorniak, PhD713-743-4802
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Houston | Houston | Texas | 77204 | Stacey L Gorniak, PhD (PRINCIPAL_INVESTIGATOR) |
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