NCT02333903撤回不适用
Effects of an Adapted Physical Activity Program on Health and Physical Condition After Sleeve Gastrectomy
Lille Catholic University2 个研究点 分布在 1 个国家开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change in the ratio of lean mass losses over total body mass losses
研究概览
简要总结
This study compares the ratio of lean mass losses over total body mass losses between patients undergoing sleeve gastrectomy followed by physical activity training versus patients undergoing sleeve gastrectomy only
详细描述
This study will assess prospectively and objectively the potential benefits of a personalized and specific rehabilitation program designed for patients who undergone sleeve gastrectomy. This strategy will help to reduce fat mass and to limit lean mass loss, in order to prevent in the short term the overweight recurrence. Also,the improvement of physical and metabolic status is expected.
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
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI >40 kg/m² or BMI>35kg/m² with comorbidities qualifying for bariatric surgery
- •Stable obesity or obesity evolving for more than 5 years
- •Patient cleared by the surgeon for sleeve gastrectomy one month before recruitment
- •Absence of contraindication for a sub-maximal stress test
- •Performance of a polysomnography before surgery
- •Signed informed consent
- •Patient benefiting from Health Care Coverage
排除标准
- •Absence of preliminary and regular medical check-ups mandatory before sleeve gastrectomy
- •Anticipated difficulty for patient follow-up
- •Mental diseases (psychosis, depression, suicidal behavior or history)
- •Eating disorders
- •Lack of informed consent or cooperation
- •Unsufficient patient commitment
- •Patient under judiciary protection
- •Patient not able to comply with any or all the research procedures over time including physical activity
- •Patient excluded from the french database of volunteers for clinical trials
结局指标
主要结局
Change in the ratio of lean mass losses over total body mass losses
时间窗: 1 month, 6 months, 12 months after surgery
Percentage of lean mass loss compared to total body weight loss measured with bioimpedancemetry and dual energy X-Rays absorptiometry (DXA) at 1, 6 and 12 months after surgery
次要结局
- Changes of insulinemia values(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Changes of creatinemia values(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Changes in systolic blood pressure(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Change in the Body Mass Index (BMI)(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Changes in the lipid profile(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Changes of glycemia values(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Changes of HbA1C values(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Changes of albuminemia values(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Change in the body composition analysis with segmental analysis(1 month, 6 months, 12 months after surgery)
- Change in the qualitative evaluation of physical activity.(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Change in the quantitative evaluation of physical activity.(1 month, 6 months and 12 months after surgery)
- Sub-maximal stress testing(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Change in the quantitative evaluation of the sleep quality(Before and 12 months after surgery)
- Change in the qualitative evaluation of the sleep quality(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Change in the energy balance(1 month, 6 months, 12 months after surgery)
- Change in the 6 min Walking test(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Change in the quantitative self esteem evaluation(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
- Change in the quantitative evaluation of the health related quality of life(1 month, 3 months, 6 months, 9 months and 12 months after surgery)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Efficiency of Physical Activity on the Physical Condition of Elderly WomenAgingNCT01558401Universidade Federal de Sao Carlos120
已完成
不适用
The Effect of the Physical Activity Program Developed According to the Precede-Proceed Model on the Physical Activity Level and Physical Activity Behavior of Elementary School StudentsPhysical ActivityPhysical Activity LevelsPhysical Activity BehaviorNCT06623604Muğla Sıtkı Koçman University89
已完成
不适用
Effects of a Weight Reduction and Lifestyle Program in Older AdultsFunctional DisabilityPhysical InactivityObesityNCT00714506University of Pittsburgh36
已完成
不适用
Adapted Physical Activity Education in Patients With Neurocognitive DisorderNeurocognitive DisordersNCT05866822Centre Hospitalier Universitaire de Nice30
撤回
早期 1 期
Diet and Exercise in Overweight Children PostburnBurnsObesityNCT00537160Shriners Hospitals for Children