Physical Fitness and Macro- and Micro- Nutrient Intake in a Morbidly Obese Bariatric Surgery Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- 1 Month Post-Operative 6 Min Walk Test
研究概览
简要总结
The purpose of this research study is to determine how bariatric surgery affects physical activity and nutrient intake.
This research study is being done because the investigators want to determine better recommendations to provide to bariatric surgery patients.
详细描述
This is a two-pronged study. The first phase is a cross-sectional study design meaning each participant will only be tested once. The investigators wish to test patients from each of the groups listed below to determine CR fitness, activity level, and nutrient intake. The investigators wish to determine if any improvements from bariatric surgery can be maintained over a 2-year period following surgery. If this is the case, our next project will be to track the patients recruited at their new visit longitudinally at all of the five time points listed below.
- New visit with GI Nutrition
- 1 month prior to bariatric surgery (at the time of the patient's initial visit with the surgeon (6-7 months after their new visit))
- 6 months after bariatric surgery
- 12 months after bariatric surgery
- 24 months after bariatric surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Competent patients enrolled in the pre- or post-operative bariatric surgery program at the Center for Nutrition and Weight Management at GMC, Danville, PA.
- •Ability to perform a 6 Minute Walk Test.
- •Aged 18 through
- •Willingness to receive dietary recall phone calls and accessibility to a telephone.
排除标准
- •Patients with severe lung disease requiring oxygen therapy.
- •Pulmonary embolus or pulmonary infarction.
- •Patients with cardiopulmonary disease (e.g., prior myocardial infarction, coronary artery bypass, or vascular stent).
- •Unstable angina.
- •Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise.
- •Patients with any health reason that limits walking.
- •Patients with a temporary injury that limits walking.
- •Patients who use a wheelchair, other assistive device for walking, or have difficulty ambulating during activities of daily living.
- •Patients predetermined to be illiterate or incompetent.
- •Patients who are currently pregnant or have been pregnant at any time since bariatric surgery.
- •Tobacco use.
- •Patients with electronic defibrillators or other embedded electronic medical devices.
- •Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands
- •Patients who have undergone revisional bariatric surgery.
结局指标
主要结局
1 Month Post-Operative 6 Min Walk Test
时间窗: 1 Month Post-Operative
6 Min Walk for Distance
6 Month Post-Operative 6 Min Walk Test
时间窗: 6 Month Post-Operative
6 Min Walk for Distance
12 Month Post-Operative 6 Min Walk Test
时间窗: 12 Month Post-Operative
6 Min Walk for Distance
24 Month Post-Operative 6 Min Walk Test
时间窗: 24 Month Post-Operative
6 Min Walk for Distance
Peak Oxygen Uptake (peak VO2)
时间窗: 36 Month Post-Operative
Measured using an incremental exercise test on an electronically breaked bike and indirect calorimetry.
Pre-Operative 6 Min Walk Test
时间窗: Pre-operative
6 Min Walk for Distance
次要结局
- Pre-operatively Physical activity(Pre-operatively)
- 1 Month Post-Operative Physical activity(1 Month Post-Operative)
- 6 Month Post-Operative Physical activity(6 Month Post-Operative)
- 12 Month Post-Operative Physical activity(12 Month Post-Operative)
- 24 Month Post-Operative Physical activity(24 Month Post-Operative)
- 36 Month Post-Operative Physical activity(36 Month Post-Operative)