Impact of Bariatric Surgery on Short Term Weight Loss- Related Changes in Gait and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Body Composition, describes change in body composition from pre-op levels
研究概览
简要总结
This is a short term study of the effects of bariatric surgery on body composition, gait parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly obese patients who are already scheduled for a bariatric surgical procedure.
详细描述
This is a prospective, exploratory, short term study of the effects of bariatric surgery on body composition, gait parameters during walking, lower extremity joint pain and quality of life (QOL) in morbidly obese patients. All patients who enroll have already agreed to undergo the bariatric procedure with their respective surgeon; the study team will simply follow specific outcome measures in addition to their normal clinical care at two time points after the surgery (week 4 and month 3).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no urgent need for bariatric procedure
- •21-65 years of age
- •body mass index (BMI) 35 kg/m2 or greater, defined as morbid obesity
- •waist circumference of < 66 inches
- •able to walk independently
排除标准
- •< 21 or > 65 years of age
- •pregnancy; psychiatric conditions; binge eating patterns; Prader-Willi syndrome; drug dependency; dementia or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol
- •uncontrolled diabetes (not using meds)
- •waist circumference of > 66 inches
- •orthopedic conditions that prevent ambulation (severe painful osteoarthritis of the hip or knee)
- •patient is wheelchair bound
结局指标
主要结局
Body Composition, describes change in body composition from pre-op levels
时间窗: Describes change over a period of 4 weeks; measured at pre-op, 2 and 4 weeks following surgery
To track changes in body composition and mass during the study, body weight body fat mass, fat free mass will be collected prior to and 2 and 4 weeks after the bariatric surgery using air plethysmography. Air plethysmography (using the BOD POD®) is a reliable technique of body volume and composition, and has been validated for use in obese individuals and is highly correlated to the gold standard of body composition assessment, underwater weighing.
次要结局
- Gait Analysis, describes change in gait parameters from pre-op levels(Describes changes in gait parameters over a 3 month period; measured at pre-op, 4 weeks and 3 months following surgery.)
- Lower Extremity Joint Pain, describes change from pre-op using a Visual Analog Scale (VAS).(Describes change in lower extremity joint pain over a period of 3 months; measured with a (VAS) at per-op, 4 weeks and 3 months following surgery)
- Medical Outcomes Short Form (SF-36), describes change in perceived quality of life (QOL)(Describes perceived (QOL) over a period of 3 months, measured at pre-op, 4 weeks and 3 months following surgery)