Supervised Whole Body Vibration Training for the Improvement of Body Composition, Microbiota and Physical Fitness After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Bone mineral density
研究概览
简要总结
Morbid obesity is defined as a complex chronic condition in which a person presents a body mass index above 40 kg/m2. This disease increases the risk of several co-morbidities and entails a reduction in life expectancy of 10 years. Its prevalence is increasing in developed countries and bariatric surgery has been suggested to be one of the best tools to counteract it. Nonetheless, this surgery also presents negative effects such as loss of bone mineral density (BMD) and muscle mass and an increased fracture risk. The aim of the present study is to elucidate the effects of surgery and a whole body vibration training (WBV) on body composition, physical fitness, microbiota and cardiometabolic markers. Twenty eight participants will undergo bariatric surgery and will be randomly allocated into a control group or a WBV group. The whole body vibration group will have a duration of 4 months in which participants will train three times per week (30 minutes per session). Measurements of body composition (dual energy x-ray and peripheral quantitative computed tomography), physical fitness (muscular strength, aerobic fitness and balance), gait biomechanics, cardiometabolic markers, gut microbiota, quality of life and physical activity levels will be registered in four different timepoints (1. Before the intervention, 2) 45 days after the surgery, 3) Six months after the surgery, and 4) 18 months after the surgery. The cost of the surgery and the exercise program will also be calculated to perform a cost-effectiveness analysis.
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
- Single (Outcomes Assessor)
盲法说明
The statistician will only have codes but in the database but will not know which code corresponds to which group.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients that are going to undergo Roux-en-Y gastric bypass with a Body mass index above 40 and below 180 kg.
- •With an age between 18 and 50 years of age
- •Living in the city of Zaragoza
排除标准
- •History of cancer in the last 5 years
- •Have a pacemaker or being diagnosed with a cardiac problem that disables the participant to take place in an exercise program
- •To have suffered an acute myocardial infarction in the last 6 months
- •To present uncontrolled hypertension
- •Fracture in the last year
- •Any other condition that the physician deems as a contraindication for performing supervised physical exercise
- •Menopause
研究组 & 干预措施
Whole body vibration
Participants will undergo a whole body vibration training
干预措施: Whole body vibration training (Device)
Control Group
Participants will not perform an intervention
结局指标
主要结局
Bone mineral density
时间窗: 18 months post-surgery
Bone density measured with dual energy x-ray
Body composition
时间窗: 18 months post-surgery
Body fat and visceral adipose tissue measured with Dual energy X-ray
Bone structure
时间窗: 18 months post-surgery
Radius strength and structure measured with peripheral quantitative computed tomography
Fecal gut microbiota
时间窗: 18 months post-surgery
Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample).
Bone mineral density
时间窗: pre-surgery
Bone density measured with dual energy x-ray
Bone mineral density
时间窗: 2 months post-surgery
Bone density measured with dual energy x-ray
Bone mineral density
时间窗: 6 months post-surgery
Bone density measured with dual energy x-ray
Bone structure
时间窗: pre-surgery
Radius strength and structure measured with peripheral quantitative computed tomography
Bone structure
时间窗: 2 months post-surgery
Radius strength and structure measured with peripheral quantitative computed tomography
Bone structure
时间窗: 6 months post-surgery
Radius strength and structure measured with peripheral quantitative computed tomography
Body composition
时间窗: pre-surgery
Body fat and visceral adipose tissue measured with Dual energy X-ray
Body composition
时间窗: 2 months post-surgery
Body fat and visceral adipose tissue measured with Dual energy X-ray
Body composition
时间窗: 6 months post-surgery
Body fat and visceral adipose tissue measured with Dual energy X-ray
Fecal gut microbiota
时间窗: pre-surgery
Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample).
Fecal gut microbiota
时间窗: 6 months post-surgery
Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample).
次要结局
- Blood glucose(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Balance(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Insulin resistance(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Albumin levels(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Quality of life of participants EUROQOL 5Q(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Physical activity levels(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- International normalised ratio test(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Agility(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Quality of life of participants SF36(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Pain scale(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Objective physical activity levels(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Cholesterol(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Basal metabolic rate(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Frailty status(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Inflammatory markers(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Liver function (ALT)(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Liver function (bilirubin)(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Liver function (GGT)(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Calcium(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Heart rate variability(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Aerobic capacity(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Muscular strength of the upper limbs(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Muscular strength of the lower limbs(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Gait kinematics(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Ankle range of motion(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Liver function (AST)(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Liver function (ALP)(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Hydroxyvitamin D(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Bone alkaline phosphatase(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Leptin(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Adinopectin(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Diet(pre-surgery, 6 months post-surgery)
- Kidney markers(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Folic acid levels(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Phosphorus(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Parathyroid hormone(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Depression, anxiety and stress questionnaire(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Iron metabolism(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
- Vitamin B12 levels(pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery)
研究者
José A. Casajús
Professor
Universidad de Zaragoza