Elevated Blood Pressure Clinical Trial
Official title:
No Time to Pause: Physical Activity to Improve Health and Well-being of Midlife Hispanic Women During the Menopausal Transition
NCT number | NCT06376812 |
Other study ID # | 23-0320 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2026 |
Est. completion date | January 2029 |
This study will test the effects of a physical activity intervention among midlife Hispanic women.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | January 2029 |
Est. primary completion date | January 2029 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Abdominal circumference | Change in abdominal circumference (cm) | Baseline to 6-months | |
Other | Abdominal circumference | Change in abdominal circumference (cm) | Baseline to 12-months | |
Other | Body mass index | Change in body mass index (kg/m2) | Baseline to 6-months | |
Other | Body mass index | Change in body mass index (kg/m2) | Baseline to 12-months | |
Primary | Days the activity monitor was worn | Objectively measured days the wearable activity monitor was worn during the intervention period | Baseline to 6-months | |
Secondary | Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months | Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period | Baseline to 6-months | |
Secondary | Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months | Mean daily minutes of moderate-vigorous intensity physical activity taken from accelerometers for a 7 day period | Baseline to 12-months | |
Secondary | Physical activity as measured by minutes of moderate intensity physical activity at 6 months | Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period | Baseline to 6-months | |
Secondary | Physical activity as measured by minutes of moderate intensity physical activity at 6 months | Mean daily minutes of moderate intensity physical activity taken from accelerometers for a 7 day period | Baseline to 12-months | |
Secondary | Physical activity as measured by minutes of vigorous intensity physical activity at 6 months | Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period | Baseline to 6-months | |
Secondary | Physical activity as measured by minutes of vigorous intensity physical activity at 6 months | Mean daily minutes of vigorous intensity physical activity taken from accelerometers for a 7 day period | Baseline to 12-months | |
Secondary | Physical activity as measured by minutes of light intensity physical activity at 6 months | Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period | Baseline to 6-months | |
Secondary | Physical activity as measured by minutes of light intensity physical activity at 6 months | Mean daily minutes of light intensity physical activity taken from accelerometers for a 7 day period | Baseline to 12-months | |
Secondary | Physical activity as measured by minutes of total physical activity at 6 months | Mean daily minutes of total physical activity taken from accelerometers for a 7 day period | Baseline to 6-months | |
Secondary | Physical activity as measured by minutes of total physical activity at 6 months | Mean daily minutes of total physical activity taken from accelerometers for a 7 day period | Baseline to 12-months | |
Secondary | Systolic blood pressure | Change in systolic blood pressure (mmHg) | Baseline to 6-months | |
Secondary | Systolic blood pressure | Change in systolic blood pressure (mmHg) | Baseline to 12-months | |
Secondary | Diastolic blood pressure | Change in diastolic blood pressure (mmHg) | Baseline to 6-months | |
Secondary | Diastolic blood pressure | Change in diastolic blood pressure (mmHg) | Baseline to 12-months |
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