Stress, Ongoing Self Monitoring and Ischemic Heart Disease Rehabilitation, a Randomized Controlled Trial (SongHeart)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- MDI depression score
研究概览
简要总结
The purpose of the study is to examine if bio feedback guided stress management by daily measurement of pressure pain sensitivity followed by acupressure reduces signs of depression and number clinical stress signs and increases quality of life in patients with stable, ischemic heart disease
详细描述
Primary outcome Measure:
MDI depression score (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory
Secondary outcome measures:
- Clinical stress signs and quality of life measures (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory, on a Clinical Stress Signs score (56 items), SF-36 and WHO-5 questionnaires
- Measure of Pressure Pain Sensitivity by a professional (designated as safety issue: no) The effect of 3 months twice daily measurements of pressure pain sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which acupressure is mandatory
- Measures of heart function: Blood pressure, the Pressure-Pulse Product (heart work), Heart Rate Variability inclusive response to Tilting, BNP (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory
- Measures of the Metabolic Syndrome: HOMA-1, Adiponectin, HBA1C, Lipids, Body Composition (time frame 3 months) (designated as safety issue: no) The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory
Tertiary outcome Measures:
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
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented stable, ischemic heart disease who have finished heart rehabilitation according to the National Guidelines > 6 months ago Actual use of aspirin, statins, and blood pressure medication according to the National Guidelines
- •Age < 75 years
- •Increased pressure pain sensitivity ≥60 as a sign of persistent stress
排除标准
- •Previous diagnosed and treated psychiatric disease besides depression Other Chronic Disease with known significantly reduced life expectancy (as cancer or severe COPD)
- •Other Chronic Disease with known significantly reduced Quality of Life as COPD, chronic pain conditions (but not diabetes or heart disease)
- •Planned heart operation
- •Changed Medication for the Heart (concerning Angina or Heart Failure) within one month
- •Previous use of the Pressure Pain Sensitivity Device followed by treatment with Acupressure
结局指标
主要结局
MDI depression score
时间窗: 3 months
The effect of 3 months twice daily measurements of Pressure Pain Sensitivity on the chest bone as a measure of the actual stress level followed by stress management of which Acupressure is mandatory
次要结局
- Clinical stress signs and quality of life measures(3 months)