No Time to Pause: Physical Activity to Improve Health and Well-being of Midlife Hispanic Women During the Menopausal Transition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Days the activity monitor was worn
研究概览
简要总结
This study will test the effects of a physical activity intervention among midlife Hispanic women.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hispanic by self-report
- •Able to speak and read English
- •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
- •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)
- •Apparently healthy
- •Self-reported ability to engage in moderate intensity physical activity
- •Access to a smart device that is compatible with a Fitbit application
排除标准
- •Self-reported physical activity of ≥150 minutes per week
- •Answered yes to any question on the Physical Activity Readiness (PAR-Q+) questionnaire
- •Post-menopausal (12-months without a menstrual cycle)
- •Diagnosed hypertension
- •Cardiovascular, respiratory, neurological, renal, endocrine, gastrointestinal and/or psychiatric diseases, or any cancers
- •Previous hysterectomy, oophorectomy, and/or uterine ablation
- •Medication to treat hypertension, elevated glucose, cholesterol, depression, anxiety, and insomnia
- •Hormonal medication via any route or implants
- •Pregnant, planning to become pregnant, or breastfeeding
- •Planning to move out of the Galveston/Houston area in the next 18 months
- •Current participation in another physical activity study or program
结局指标
主要结局
Days the activity monitor was worn
时间窗: Baseline to 6-months
Objectively measured days the wearable activity monitor was worn during the intervention period
次要结局
- Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months(Baseline to 12-months)
- Systolic blood pressure(Baseline to 12-months)
- Physical activity as measured by minutes of light intensity physical activity at 6 months(Baseline to 12-months)
- Physical activity as measured by minutes of moderate intensity physical activity at 6 months(Baseline to 12-months)
- Physical activity as measured by minutes of vigorous intensity physical activity at 6 months(Baseline to 12-months)
- Physical activity as measured by minutes of total physical activity at 6 months(Baseline to 12-months)
- Diastolic blood pressure(Baseline to 12-months)