EFFECT of PYRAMIDAL TRAINING on EPICARDIAL FAT for CORONARY ARTERY DISEASE PREVENTION
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Epicardial adipose tissue thickness.
研究概览
简要总结
To show the effect of pyramidal training for coronary artery disease prevention on:
-Epicardial fat, BMI, Waist circumference (WC), Lipid profile, Quality of life and Mediterranean Diet Adherence.
详细描述
Back Ground: Coronary heart disease (CHD) is a type of ischemic heart disease characterized by atherosclerotic plaque accumulation in the coronary arteries.Obesity leads to coronary artery disease (CAD) in part through an inflammatory process that accelerates atherosclerotic plaque formation which may start as early as childhood. Epicardial adipose tissue (EAT) is the Visceral adipose tissue (VAT) of the heart .EAT has unique embryologic, anatomic, and histologic features, including smaller adipocytes and higher prevalence of immune cells when compared to subcutaneous adipose tissue (SAT).
Purpose: To show the effect of pyramidal training for coronary artery disease prevention on:
-Epicardial fat, BMI, Waist circumference (WC), Lipid profile, Quality of life and Mediterranean Diet Adherence.
Methods: This study is Randomize Control Trail that will be carried out on 50 females' patients and will be selected from the Outpatient clinics at Pharos University. Patient will be randomly assigned to two groups.
Experimental group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fifty females' patients with class I obesity (BMI 30 to 34.9 kg/m2, Waist circumference > 88 cm).
- •Their age ranges from 30-40 years old.
- •Dyslipidemia and lipid profile as follow (total cholesterol high: 240 mg/dl, HDL less than 40 mg/dl, LDL high: 160-189 mg/dL and triglycerides high: 200-499 mg/dl).
- •All patients will be clinically and medically stable when attending the study.
排除标准
- •Patients with conditions will be excluded such as:
- •Musculoskeletal problems.
- •Chronic pulmonary disease.
- •Missed more than two weeks of the program or want to terminate the program.
- •Unstable angina.
- •Acute illness.
- •Uncontrolled cardiac arrhythmia.
- •Decompensated heart failure.
- •Cognitive impairment or mental disorders.
- •Systolic blood pressure higher than 180, and/or diastolic blood pressure over 100mmHg.
- •Multiple food allergies/intolerances or gastrointestinal difficulties of the prescribed diet.
- •Cancer (have special nutritional and training needs).
研究组 & 干预措施
Experimental group:
This group will include 25 patients who will receive pyramidal aerobic training by treadmill for 40 minutes per session (three sessions per week) for (12 weeks) in addition to Mediterranean diet.
干预措施: Pyramidal training (Other)
Experimental group:
This group will include 25 patients who will receive pyramidal aerobic training by treadmill for 40 minutes per session (three sessions per week) for (12 weeks) in addition to Mediterranean diet.
干预措施: Mediterranean diet (Other)
Control group
This group will include 25 patients who will receive Mediterranean diet for (12 weeks).
干预措施: Mediterranean diet (Other)
结局指标
主要结局
Epicardial adipose tissue thickness.
时间窗: 12 weeks
The echo measurements for EATT will be taken in standard parasternal view in the left lateral decubitus position by an experienced cardiologist, and the mean values between long- and short-axis views will record. The EAT is identify as the echo-free space between the outer wall of the myocardium and the visceral layer of the pericardium. The thickness is measure perpendicularly on the free wall of the right ventricle at end systole in three to ten cardiac cycles
次要结局
- (lipid profile) Blood test(12 weeks)
- Anthropometric measurements(12 weeks)
- Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)(12 weeks)
- 14-Item Mediterranean Diet Adherence Screener (MEDAS)(12 weeks)
研究者
Rawda Mohamed Ahmed Mohamed El Komy
Principle investigator
Cairo University