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El ensayo clínico NCT06376812 para Presión arterial elevada, Perimenopausia está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT06376812 es un ensayo intervencionista para Presión arterial elevada, Perimenopausia. Su estado actual es: reclutando. El ensayo se inició el 20 de febrero de 2025, con el objetivo de reclutar a 40 participantes. Dirigido por The University of Texas Medical Branch, Galveston, se espera que finalice el 1 de enero de 2029. Los datos se actualizaron por última vez en ClinicalTrials.gov el 19 de noviembre de 2025.
Resumen
This study will test the effects of a physical activity intervention among midlife Hispanic women.
Descripción detallada
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.
Título oficial

No Time to Pause: Physical Activity to Improve Health and Well-being of Midlife Hispanic Women During the Menopausal Transition

Condiciones médicas
Presión arterial elevadaPerimenopausia
Otros ID del ensayo
  • 23-0320
Número del NCT
NCT06376812
Inicio del ensayo (real)
2025-02-20
Última actualización
2025-11-19
Fecha de finalización (estimada)
2029-01
Inscripción (prevista)
40
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
Physical activity
Women's health
Minority health
Behavior change
Hypertension prevention
Objetivo principal
Prevención
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalPhysical activity intervention
Multi-level intervention to increase physical activity
Intervención de actividad física
Physical activity
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Days the activity monitor was worn
Objectively measured days the wearable activity monitor was worn during the intervention period
Baseline to 6-months
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
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
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
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
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
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
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
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
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
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
Systolic blood pressure
Change in systolic blood pressure (mmHg)
Baseline to 6-months
Systolic blood pressure
Change in systolic blood pressure (mmHg)
Baseline to 12-months
Diastolic blood pressure
Change in diastolic blood pressure (mmHg)
Baseline to 6-months
Diastolic blood pressure
Change in diastolic blood pressure (mmHg)
Baseline to 12-months
Criterios de elegibilidad

Criterios de edad
Adulto
Edad mínima
45 Years
Criterios de sexo
Mujer
  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

  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
The University of Texas Medical Branch, Galveston logoThe University of Texas Medical Branch, Galveston
Contactos centrales del ensayo
Contacto: Lisa Thibodeaux, BSN, RNC-OB, 409-747-1756, [email protected]
1 Sitios del ensayo en 1 países

Texas

University of Texas Medical Branch, Galveston, Galveston, Texas, 77555, United States
Lisa Thibodeaux, Contacto, [email protected]
Elizabeth Lorenzo, PhD, Investigador principal
Reclutando