Time-Efficient Inspiratory Muscle Strength Training for Reducing Sympathetic Activity and Improving Sleep in Midlife Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in blood pressure
研究概览
简要总结
The purpose of this research is to understand how training the muscles used for breathing (inhalation) affects menopausal hot flashes, sympathetic nerve activity and sleep.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 45-60 with hot flashes.
- •Participants will be recruited from Rochester, MN and surrounding areas.
- •Non-smokers.
- •BMI < 40kg/m^
- •No history of cardiovascular disease, except for hypertension.
排除标准
- •Detailed medical and social histories will be collected. To allow for ecological validity, participants will not be excluded for use of menopausal hormone therapy or medications affecting cardiovascular function so long as they have been on a consistent regimen for ≥3 months and during the study period. This approach to medications is consistent with recent work in this area.
- •Participants will be screened for contraindications to inspiratory muscle strength training including, a history of spontaneous pneumothorax, collapsed lung that has not healed fully, a perforated eardrum that has not healed fully, and/or any other condition of the eardrum.
- •Additional exclusion criteria will include the use of sleep aids (i.e., prescription, melatonin, doxylamine, valerian root, etc.).
研究组 & 干预措施
High-Resistance Inspiratory Muscle Strength Training Group
Subjects will partake in 5 sets of 6 inspiratory maneuvers (total: 30 maneuvers/session) 6 days a week for 6 weeks using the POWERbreathe K3 device to monitor adherence.
干预措施: POWERbreathe K3 device (Device)
High-Resistance Inspiratory Muscle Strength Training Group
Subjects will partake in 5 sets of 6 inspiratory maneuvers (total: 30 maneuvers/session) 6 days a week for 6 weeks using the POWERbreathe K3 device to monitor adherence.
干预措施: High-Resistance Inspiratory Muscle Strength Training (Behavioral)
Low-Resistance Inspiratory Muscle Strength Training Group
Subjects will partake in 5 sets of 6 inspiratory maneuvers (total: 30 maneuvers/session) 6 days a week for 6 weeks using the POWERbreathe K3 device to monitor adherence.
干预措施: Low-Resistance Inspiratory Muscle Strength Training (Behavioral)
Low-Resistance Inspiratory Muscle Strength Training Group
Subjects will partake in 5 sets of 6 inspiratory maneuvers (total: 30 maneuvers/session) 6 days a week for 6 weeks using the POWERbreathe K3 device to monitor adherence.
干预措施: POWERbreathe K3 device (Device)
结局指标
主要结局
Change in blood pressure
时间窗: Baseline, 6 weeks
Measured in millimeters of mercury (mm Hg)
Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency
时间窗: Baseline, 6 weeks
Measured by microneurography reported in burst per minute
Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence
时间窗: Baseline, 6 weeks
Number of bursts recorded via microneurography
次要结局
- Change in Hot Flash Frequency(Baseline, 6 weeks)
- Chang in sleep duration(Baseline, 6 weeks)
- Change in wake after sleep onset(Baseline, 6 weeks)
- Change in Pittsburgh Sleep Quality Index(Baseline, 6 weeks)
研究者
Sarah E. Baker, Ph.D.
Principal Investigator
Mayo Clinic