Effects of Exercise on Body Composition, Cardiovascular Risk Factors and Surgery Complications in Bariatric Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Change in body composition - Body mass index
研究概览
简要总结
Background: Patients awaiting bariatric surgery, apart from suffering higher BMI, show a large number of comorbidities and a low physical fitness. These factors are associated with a longer surgery time, a longer hospital stay and a greater number of operative complications. To reduce these disadvantages, a nutritional intervention is performed to reduce total weight and the comorbidities associated with obesity prior to surgery. However, the prescription of an exercise program, which can be an effective tool to improve these factors, is not usually part of the usual care of these patients.
Objective: To know the effects of a semi-supervised exercise program on body composition, cardiovascular risk factors and operative complications in bariatric patients.
Methods: Approximately 3 months before surgery, 60 patients awaiting bariatric surgery will be recruited. Patients will be randomized into two groups: a) an experimental group (n = 30); b) a control group (n = 30). The experimental group will perform a semi-supervised exercise program, while the control group will only perform the corresponding evaluations. Both groups will be assessed for body composition, cardiovascular risk factors, physical condition, quality of life and physical activity levels at the beginning and at the end of the intervention. In addition, surgery time, hospital length of stay and operative complications will be evaluated in both groups.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-55 years.
- •All patients awaiting bariatric surgery.
排除标准
- •Patients with chronic respiratory diseases
- •Patients with cardiovascular diseases
- •Inability to perform exercise
研究组 & 干预措施
Exercise group
Three months of semi-supervised exercise program in patients awaiting bariatric surgery. Body composition, cardiovascular risk factors, physical fitness, physical activity levels and quality of life will be assessed before and at the end of the study. In addition, surgery time, hospital length of stay and operative complications also will be evaluated.
干预措施: Exercise program (Behavioral)
Control group
The control group only will perform the evaluations of the study.
结局指标
主要结局
Change in body composition - Body mass index
时间窗: Baseline and 3 months, between 8:00 AM and 9:00 AM.
Bioimpedance analysis will be used for establishing body weight and body composition. This variables will be evaluated between 8:00 and 9:00 A.M., after at least 8 hours of fasting, with an empty bladder. Body mass index will be calculated dividing weight in kilograms by squared height in meters. Therefore, body mass index will be expressed as kg·m-2.
Change in glucose and HbA1c levels.
时间窗: Baseline and 3 months, between 8:00 AM and 10:00 AM.
Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.
Change in total cholesterol, HDL cholesterol and LDL cholesterol levels.
时间窗: Baseline and 3 months, between 8:00 AM and 10:00 AM.
Blood samples will be taken after a 12 h of overnight fast. Exercise will be forbidden 48 h before the test.
Change in systolic and diastolic blood pressure.
时间窗: Baseline and 3 months, between 8:00 AM and 9:00 AM.
Systolic and Diastolic Blood pressure will be measured according to established recommendations.
Complications rates
时间窗: Day 30 after surgery.
All the complications suffered by patients will be recorded.
Length of stay.
时间窗: Day 15 after surgery.
The number of days at hospital after bariatric surgery will be recorded.
Change in handgrip strength
时间窗: Baseline and 3 months, between 5:00 PM and 8:00 PM.
Strength levels will be assessed using a hand dynamometer.
次要结局
- Change in physical activity levels.(Baseline and 3 months, seven days.)
- Change in health-related quality of life: sf-36 questionnaire.(Baseline and 3 months.)
- Change in waist and hip circumference.(Baseline and 3 months, between 8:00 AM and 9:00 AM.)
研究者
Jaime Ruiz-Tovar, MD, PhD
Department of Surgery
Hospital General Universitario Elche