Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT06376812
Eligibility Criteria:
Inclusion Criteria:
1. Female
2. Hispanic by self-report
3. Able to speak and read English
4. Sedentary
5. Age 45-50
6. Diagnosed with elevated blood pressure or objectively measured systolic blood pressure 120-139 mmHg and/or diastolic blood pressure 80-89 mmHg averaged from ≥ 2 measures on ≥ 2 outpatient visits
7. Symptoms consistent with the menopause transition (persistent difference of ≥7 days in the length of consecutive cycles; persistence is defined as recurrence within 10 cycles of the first variable length cycle)
8. Apparently healthy
9. Self-reported ability to engage in moderate intensity physical activity
10. Access to a smart device that is compatible with a Fitbit application
Exclusion Criteria:
1. Self-reported physical activity of ≥150 minutes per week
2. Answered yes to any question on the Physical Activity Readiness (PAR-Q+) questionnaire
3. Post-menopausal (12-months without a menstrual cycle)
4. Diagnosed hypertension
5. Cardiovascular, respiratory, neurological, renal, endocrine, gastrointestinal and/or psychiatric diseases, or any cancers
6. Previous hysterectomy, oophorectomy, and/or uterine ablation
7. Medication to treat hypertension, elevated glucose, cholesterol, depression, anxiety, and insomnia
8. Hormonal medication via any route or implants
9. Tamoxifen
10. Pregnant, planning to become pregnant, or breastfeeding
11. Planning to move out of the Galveston/Houston area in the next 18 months
12. Current participation in another physical activity study or program
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
50 Years
Study:
NCT06376812
Study Brief:
Protocol Section:
NCT06376812