A Perspective Randomized Study of Impact of Stress Management Involved Cardiac Rehabilitation on Psychological States and Clinical Outcomes of Patients After Acute Myocardial Infarction or Heart Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- The score of Chinese perceived stress scale decreased.
研究概览
简要总结
The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure.
详细描述
The purposes of this study is to evaluate the improvement of a stress management involved cardiac rehabilitation program on the psychological states, quality of life and clinical outcomes of patients after acute myocardial infarction or heart failure. The investigators performed modified cardiac rehabilitation program involving stress management on the patients who suffered from acute myocardial infarction or severe heart failure who were admitted to the CCU. Then the psychological states, quality of life and clinical outcomes were followed up.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years old with a diagnosis of AMI (include ST segment elevated myocardial infarction and non-ST segment elevated myocardial infarction) or heart failure
排除标准
- •Uncontrolled tachycardia (heart rate at rest >120bpm
- •Uncontrolled polypnea（breath rate at rest >30 breath per minute
- •Uncontrolled respiratory failure （SPO2 ≤90%）
- •Uncontrolled hypertension （pre-exercise SBP>180mmHg or DBP>110mmHg）
- •Weight change in 72 hours >1.8kg
- •Uncontrolled hyperglycemia (Random blood glucose>18mmol/L)
- •Uncontrolled malignant arrhythmia with hemodynamic instability
- •Unoperated pseudoaneurysm、artery dissection
- •Uncontrolled septic shock and septicopyemia
- •Unoperated severe valvular heart disease or acute phase of heart failure caused by myocardial heart disease
- •nervous system disease, motor system diseases and rheumatic diseases considered possibly worsened by exercise
- •Uncooperation of the patients
研究组 & 干预措施
Traditional CR Group
Group received cardiac rehabilitation including education and exercise
干预措施: Traditional CR (Behavioral)
Stress-Modified CR Group
Group received cardiac rehabilitation including education, exercise and stress management
干预措施: Modified CR (Behavioral)
Control Group
Group received education only
干预措施: Education (Behavioral)
结局指标
主要结局
The score of Chinese perceived stress scale decreased.
时间窗: 6 month
The score of Chinese perceived stress scale (CPSS, 0-56, higher means more stress) decreased.
The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (36-Item Short Form Survey) increased
时间窗: 6 month
The score of Medical Outcomes Study Questionnaire Short Form 36 Health Survey (abbreviation form is 36-Item Short Form Survey) increased. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability, The sections consists of Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, and Mental health. The total score of SF 36 Health survey is higher, the quality of life is higher.
The score of anxiety test questionnaire decreased
时间窗: 6 month
The score of anxiety test questionnaire(Generalized Anxiety Disorder,GAD-7, normal range 0-21, partially reflecting the severity of anxiety with the higher score) decreased
The score of patient health questionnaire decreased
时间窗: 6 month
The score of patient health questionnaire (PHQ9, normal range 0-27，indicating the profile of depression with the higher score) decreased
次要结局
- incidence of MACE in patients with heart failure(6 month)
- improvement of exercise capacity(6 month)
- incidence of MACE in patients after acute myocardial infarction(6 month)
- incidence of rehospitalization(6 month)
研究者
Jing Ma
Clincial professor
Chinese PLA General Hospital