Effects of Breathing Training on Psychosocial Functioning and Heart Rate Variability in Postmenopausal Women With Depressive Symptoms-3
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Depressive symptoms
研究概览
简要总结
The specific aims of this study are:
- To develop a breathing training protocol specifically designed to improve HRV and psychosocial functioning for postmenopausal women with depressive symptoms,
- To examine the immediate effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms,
- To examine the intermediate-term effects of an 8-week breathing training program on HRV and psychosocial end points in postmenopausal women with depressive symptoms, and
- To determine whether the change in depressive symptoms with breathing training in postmenopausal women is associated with the change in HRV.
详细描述
Postmenopausal women without hormone replacement therapy are associated with higher risk of cardiac morbidity and mortality. They are likely to experience depressive symptoms after menopause, and the comorbidity of depression are related to altered autonomic function. We expect that postmenopausal women with depressive symptoms who receive breathing training will demonstrate decreased depressive symptoms and increased heart rate variability immediately upon and later after completion of training, and optimally contributing to improve autonomic nervous regulation in their later life to prevent undesired cardiac outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Permanent termination of menstruation of natural cause.
- •Cessation of menstrual cycles for more than 12 consecutive months.
- •A score of the Chinese version of Beck Depression Inventory-II of greater than
- •Able to speak Mandarin or Taiwanese.
- •Age from 45 to 64 years.
排除标准
- •Subjects who are clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis, mental deficiency.
- •Subjects who received hormone replacement therapy prescribed by gynecological physicians.
- •Subjects who took cardiac and/or psychotropic medications which may affect the autonomic functions
结局指标
主要结局
Depressive symptoms
时间窗: follow-up (16 weeks from baseline)
次要结局
- Heart rate variability (Resting, reactivity to stress, and recovery from stress)(follow-up (16 weeks from baseline))
研究者
Pei-Shan Tsai
Professor, College of Nursing, Taipei Medical University
National Science Council, Taiwan