Effect of Individualized Exercise Based on CPET on Multiple Cardiovascular Risk Factors and Cardiopulmonary Function in Elderly Patients With Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- LDL
研究概览
简要总结
The benefits of cardiac rehabilitation have been supported by a large amount of evidence-based medicine. Cardiac rehabilitation can correct cardiovascular risk factors, reduce morbidity and mortality, and improve quality of life.
详细描述
Cardiac rehabilitation includes drug, exercise, nutrition, psychological and behavioral intervention, smoking and alcohol restriction five prescription comprehensive medical measures, so as to improve the symptoms and prognosis of patients. Cardiac rehabilitation can not only delay the progress of the disease and improve the prognosis, but also improve the physical and mental state of patients, which has been recommended by the European Cardiology Association, the American Heart Association and the American Heart Association as Class I in the treatment of cardiovascular disease. Through the comprehensive intervention of patients, their physical, psychological and social functions can be restored to the best state, which can prolong life and significantly improve the quality of life, which is the essence of modern cardiac rehabilitation. Exercise rehabilitation is the core content of cardiac rehabilitation, which refers to the use of appropriate body exercise to help patients promote physical and mental health through exercise prescription and exercise guidance on the basis of comprehensive evaluation. The realization of sports rehabilitation requires a reasonable exercise prescription, which refers to the method of prescribing patients' exercise content and amount of exercise in the form of prescription according to individual physical condition and combining with environment and preference as far as possible. The best exercise prescription should be able to comprehensively promote health-related physical fitness, that is, cardiopulmonary endurance, muscle strength and endurance, flexibility, body composition and neuromotor fitness, and should be formulated in accordance with the principles of FITTVP, including frequency (several times a week), intensity (exertion), time (duration or total time), mode (pattern or type), as well as total and progress.
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
- None
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary heart disease: coronary angiography confirmed patients with coronary heart disease.
- •Age is 60-75 years old, and the clinical sinus rhythm is stable.
- •Left ventricular ejection fraction was> 40%.
- •Informed consent and voluntary participation.
排除标准
- •Patients with severe organic cardiac and lung diseases.
- •Patients with hemiplegia and other physical action disorders.
- •A history of mental illness.
- •Uncontrolled hypertension, and hemodynamic instability.
- •Severe nephropathy and severe peripheral artery disease.
- •Patients with bone and joint diseases who are not suitable for exercise.
- •Uncontrolled endocrine system and other diseases.
- •Antibiotics and anti-diarrheal medications have not been used for at least 3 months.
研究组 & 干预措施
the control group
The patients in the control group were treated with routine rehabilitation nursing, while those in the control group were treated with routine antiplatelet drugs and lipid-lowering drugs after operation. Professional salesmen, according to the specific physical conditions of the patients, formulate corresponding recipes to ensure that the patients have a light diet, low salt, low fat and high nutritional value, and prohibit tobacco and alcohol.
干预措施: optimal medical therapy ：aspirin, clopidogrel, statins. (Drug)
the exercise group
The exercise group was given individualized rehabilitation training intervention on the basis of the control group. After 2 weeks of adaptive exercise training, there were no adverse events and voluntarily continued the participants. Under the guidance of the specialist, the exercise group received moderate and high intensity interval training, 3 times a week, 30-40 minutes each time, including the beginning of 5 minutes of warm-up and the last 5 minutes of cooling-off period.
干预措施: Individual rehabilitation exercise training (Behavioral)
the exercise group
The exercise group was given individualized rehabilitation training intervention on the basis of the control group. After 2 weeks of adaptive exercise training, there were no adverse events and voluntarily continued the participants. Under the guidance of the specialist, the exercise group received moderate and high intensity interval training, 3 times a week, 30-40 minutes each time, including the beginning of 5 minutes of warm-up and the last 5 minutes of cooling-off period.
干预措施: optimal medical therapy ：aspirin, clopidogrel, statins. (Drug)
结局指标
主要结局
LDL
时间窗: one year
low density lipoprotein
VO2peak
时间窗: one year
peak oxygen uptake
Gut microbiome
时间窗: one year
Fecal DNA isolation was performed using the QIA amp Fast DNA Stool Mini Kit (Qiagen, cat. 51604). After DNA extraction, fecal DNA was used for library preparation, and whole-genome shotgun sequencing was performed on the Illumina NovaSeq-6000 plat- form. From the raw metagenomic sequencing data, low-quality reads were discarded by the sequencing facility and reads belonging to human contaminations were removed by mapping the data to the reference genomes using Bowtie2. After filtering, on average, 54.8 million paired reads per sample were obtained for subsequent analysis.
Plasma metabolites profiles
时间窗: one year
Microbial metabolites profiles were generated using MetaPhlAn4 (version 4.0.3).
6MWT
时间窗: one year
6-minute walk test
次要结局
- Plasma metabolites concentration(one year)
研究者
Chen Leilei
Director
The First Affiliated Hospital with Nanjing Medical University