The Effect of Weight Loss and Exercise on Cardiovascular Disease Risk Factors in Class II and III Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Cardiovascular Disease Risk Factors
研究概览
简要总结
The purpose of this study is to examine the effect of weight loss and exercise on cardiovascular disease risk factors, specifically inflammation as measured by C-Reactive Protein and cardiac structure and function as measured by cardiac MRI, in Class II and III obese women during a 12 week training intervention.
详细描述
To date, research investigating obesity, inflammation, and cardiovascular disease has utilized lifestyle interventions focused on weight loss and exercise among groups with BMI classifications of normal, overweight and mildly obese. A limitation of recent investigations is the failure to utilize participants who are significantly overweight. Those whose BMI classification extends to Class II and Class III obesity (BMI > 35.0, and BMI > 40.0) have not yet been studied at length, yet these individuals have been shown to be able to substantially improve their cardiovascular risk profiles without attaining a BMI below 25. Inactivity has been linked to increased adiposity and a trend toward higher levels of cardiovascular disease risk. It is necessary to study the relationships between weight loss and weight loss with added physical activity among Class II and Class III obese participants in order to gain a more thorough knowledge of the effects of BMI on circulating markers of inflammation and the cardiac structural and functional changes associated with weight loss among this population. A second limitation of the current research is the use of strictly progressive resistance training protocols. The protocols used have increased constantly in intensity or volume, if not both. Constant increases in intensity tend to lead to overtraining among participants, highlighting a need for more variation of intensity and volume in the training protocol in order to avoid stagnation and overtraining. Finally, no research has studied the specific impact of diet and resistance training on either CRP or cardiovascular adaptations.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •30-55 years of age
- •BMI = 35.0-44.9 kg/m2
排除标准
- •Currently pregnant, pregnant in the past 6 months, or planning on becoming pregnant in the next 6 months.
- •Regularly exercising for greater than 60 minutes per week.
- •Taking prescription or over-the-counter medications that affect body weight, metabolism, blood pressure, or heart rate, such as psychotropic medications (e.g. zoloft, prozac, paxil, xanax) and medications that have metabolic effects (e.g. synthroid, wellbutrin, metformin).
- •Having physical limitations that hinder or prevent exercise.
- •Currently being treated for coronary heart disease, diabetes mellitus, hypertension, or cancer.
- •Having a resting systolic blood pressure of > 150mmHg of diastolic blood pressure of > 100mmHg or currently taking any medications that affect blood pressure or heart rate (i.e. beta blockers).
- •Currently enrolled in an exercise or weight control study or participating in an exercise or weight control study in the past 6 months.
- •Have lost and not regained > 5% body weight in the past 6 months.
- •Currently being treated for any psychological problems or taking any psychotropic medications.
- •Abnormal kidney functions, as per current institutional standard for gadolinium administration.
- •Known allergy to IV gadolinium, or the discovery of an allergic reaction to IV gadolinium at baseline.
结局指标
主要结局
Cardiovascular Disease Risk Factors
时间窗: 0 and 12 weeks
Inflammation as determined by C-Reactive Protein and Cardiac Structure and Function as defined by left ventricular mass, aortic pulse wave velocity, fibrosis, and ejection fraction.
次要结局
- Weight Loss(0 and 12 weeks)