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Clinical Trial Details — Status: Not yet recruiting

Administrative data

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

Study information

Verified date April 2024
Source The University of Texas Medical Branch, Galveston
Contact Lisa Thibodeaux, BSN, RNC-OB
Phone 409-747-1756
Email lbthibod@utmb.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will test the effects of a physical activity intervention among midlife Hispanic women.


Description:

The menopausal transition in midlife is a critical juncture where women experience life transitions and adverse physiological and psychological changes that increase the risk for hypertension and cardiovascular diseases in later life. Physical activity improves blood pressure, biomarkers of hypertension, sleep, mood, and well-being; however, Hispanic women meet physical activity recommendations at lower levels than non-Hispanic White women. The investigator will examine the feasibility of the physical activity intervention among sedentary midlife Hispanic women in the menopausal transition with elevated blood pressure, exploring changes in physical activity and health.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical activity intervention
Physical activity

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston

Outcome

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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