Effects of Controlled Physical Activity on the Fitness, Body Composition and Quality of Life of Obese Women Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Maximum oxygen consumption (VO2 max)
研究概览
简要总结
Bariatric surgery indeed leads to significant weight loss, reduces mortality risk, obesity-associated comorbidities (Wolfe et al., 2016) and improves functional physical abilities (Herring et al., 2016). Because these benefits are related to decreased energy intake, the investigators aim to optimize them by combining them with supervised adapted physical activity practice.
So, the aim of this clinical trial is to measure the effects of a physical training program on physical fitness, body composition and quality of life of obese women who have undergone bariatric surgery.
详细描述
Upon hospitalization for their bariatric surgery (bypass or sleeve), subjects will sign their informed consent and be included in the study. Six weeks' post-surgery, the subjects will be randomized in one of the 2 groups (Control group CG or Adapted Physical Activity group APAG). Patients in both groups will have 3 postoperative visits one at 6 weeks (V1), one at 18 weeks (V2) and one at 30 weeks (V3). During these visits, they will undergo the same assessments (body composition, physical condition, quality of life). Patients in the CG will receive standard hospital management. Patients in APAG will follow the same management and will also follow a 3-month physical activity program 3 times a week between V1 and V2. Then, between V2 and V3, no APA program will be offered to both groups.
The subjects will evaluate during each visit V1, V2 and V3:
- body composition,
- physical condition,
- quality of life
- daily physical activity
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
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women between 18 and 55 years old
- •undergoing bariatric surgery (a "bypass gastric" or a "sleeve")
- •not practicing a supervised physical activity
- •having read and signed an informed consent prior to the start of the trial
- •being affiliated to a social security system
排除标准
- •Women with a contraindication to physical activity
- •any medical contraindication to the practice of stress tests.
- •unable to go to the hospital regularly
- •having a significant functional limitation that does not allow her to perform the 6-minute walk test
- •with an intellectual disability and/or psychiatric illness
- •does not speak and/or understand French
- •pregnant woman
- •under guardianship or curatorship
- •participating in another clinical research
结局指标
主要结局
Maximum oxygen consumption (VO2 max)
时间窗: Week 30
The VO2 max is measured during an effort test with progressively increasing and maximum load which consists in making the subject pedal against an increasing load
次要结局
- Heart rate(Week 30)
- Perception of the effort(Week 36)
- Impact of obesity on the physical, psycho-social, dietary well-being and dieting experience assessed using the Quality of Life, Obesity and Diet Scale (QOLDS)(Week 30)
- Walking distance(Week 30)
- grip strength(week 30)
- Hormonal measurements(week 30)
- Maximum voluntary force of the quadriceps(week 30)
- Body composition(week 30)
- Metabolic measurements(week 30)