Effects of a Home-based Breathing Training on Menopausal Symptoms Among Community Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Menopausal symptoms
研究概览
简要总结
This is a prospective, triple-blinded and randomized controlled trial examining the effects of a home-based breathing training assisted with biofeedback on menopausal symptoms and autonomic functions among community menopausal women. We also examines whether the changes in autonomic functions would be mediators between slow breathing and menopausal symptoms. This study will include menopausal women, aged from 45 to 64, who experienced menopausal symptoms. Participants will be randomly assigned to either an intervention group (n = 80) or a waiting-list control group (n = 80). The intervention group will undergo the home-based breathing training 20 minutes twice daily and participants in the control condition will participate the same breathing training after a four-week waiting list period. The primary outcome measures are menopausal symptoms measured by symptom diaries of menopausal symptoms and the Greene Climacteric Scale (GCS). Secondary outcome measures are autonomic functions expressed by blood pressure (BP), heart rate (HR) and heart rate variability (HRV). Measurements will be taken at baseline, week 4, and week 8.
详细描述
Ditto
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged from 45 to 64, reporting cessation of menstrual cycles with natural causes ≧ 12 consecutive months
- •the Greene Climacteric Scale (GCS) Chinese version scores ≧ 1
排除标准
- •clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis or mental deficiency
- •received hormone replacement therapy prescribed by gynecological physicians
- •took cardiac medications which may affect the autonomic functions, ex., β-blockers, etc.
结局指标
主要结局
Menopausal symptoms
时间窗: Posttest (4 weeks from baseline)
Assessments using the Greene Climacteric Scale (GCS) for self-reported menopausal symptoms
次要结局
- Autonomic functions (Blood pressure)(Posttest (4 weeks from baseline))
- Autonomic functions (heart rate)(Posttest (4 weeks from baseline))
- Autonomic functions (heart rate variability)(Posttest (4 weeks from baseline))
研究者
Yuh-Kae Shyu
Assistant Professor
Ministry of Science and Technology, Taiwan