Fitness, Physical Activity and Movement Analysis in Obese Patients Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- functional capacity
研究概览
简要总结
This study aims to describe the effects of sleeve gastrectomy, the most commonly performed bariatric procedure worldwide, on functional capacity, habitual physical activity, physical fitness (cardiorespiratory and muscular fitness) and gait parameters in severely obese subjects undergoing bariatric surgery. Functional capacity, physical activity, physical fitness and gait parameters will be objectively assessed and compared among candidates seeking sleeve gastrectomy and 6 months after sleeve gastrectomy.
详细描述
This study is a monocentric longitudinal study conducting in obese patients: candidates to sleeve gastrectomy and these same patients 6 months after.The primary aim of this study is to describe the effects of sleeve gastrectomy on habitual physical activity, physical fitness (cardiorespiratory and muscular fitness) and gait parameters in severely obese patients. Functional capacity will be assessed during a 6-min walk test, habitual physical activity with accelerometers during 7-day recordings in habitual life conditions (Actigraph GT3X® and activPAL®), cardiorespiratory fitness during a maximal exercise test on a cycle ergometer with a direct measure of peakVO2, muscle strength with an isokinetic dynamometer (Contrex®), muscle power and postural stability with force platforms (Kistler® and Satel®) and gait parameters with a gait analysis system (GaitRite®). Fatigue, quality of life and joint pain will be assessed with questionnaires (MFI-20, SF36 and WOMAC, respectively).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender
- •Age between 18 and 65 years
- •Planned obesity treatment by sleeve gastrectomy
- •Patient with massive obesity (BMI ≥ 40 kg/m2) or severe obesity (BMI between 35 and 40 kg/m2) with comorbidities
- •Written informed consent
排除标准
- •Subject not affiliated with a social security scheme
- •Regular follow-up not feasible
- •Participation in a structured physical activity program
- •Severe orthopedic problems
- •Disabling neuropathy
- •Recent (< 6 months) coronary event
- •Abnormal cardiac stress test
- •Pregnancy
结局指标
主要结局
functional capacity
时间窗: before and 6 months after sleeve gastrectomy
Difference in functional capacity (6-min walk test distance)
次要结局
- muscle strength ( isokinetic dynamometer (Contrex®))(before and 6 months after sleeve gastrectomy)
- cardiorespiratory fitness ( cycle ergometer )(before and 6 months after sleeve gastrectomy)
- habitual physical activity (Actigraph GT3X® and activPAL®)(before and 6 months after sleeve gastrectomy)