Bariatric Surgery and Whole Body Vibration TrainingBariatric Surgery
Investigational drug(s) / intervention(s)
Whole body vibration training
Whole body vibration training: 3 times per week of 20 to 30 minute sessions during 16 weeks of training
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Bone mineral density — pre-surgery Bone density measured with dual energy x-ray
Bone mineral density — 2 months post-surgery Bone density measured with dual energy x-ray
Bone mineral density — 6 months post-surgery Bone density measured with dual energy x-ray
Bone mineral density — 18 months post-surgery Bone density measured with dual energy x-ray
Bone structure — pre-surgery Radius strength and structure measured with peripheral quantitative computed tomography
Bone structure — 2 months post-surgery Radius strength and structure measured with peripheral quantitative computed tomography
Bone structure — 6 months post-surgery Radius strength and structure measured with peripheral quantitative computed tomography
Bone structure — 18 months post-surgery Radius strength and structure measured with peripheral quantitative computed tomography
Body composition — pre-surgery Body fat and visceral adipose tissue measured with Dual energy X-ray
Body composition — 2 months post-surgery Body fat and visceral adipose tissue measured with Dual energy X-ray
Body composition — 6 months post-surgery Body fat and visceral adipose tissue measured with Dual energy X-ray
Body composition — 18 months post-surgery Body fat and visceral adipose tissue measured with Dual energy X-ray
Fecal gut microbiota — 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 — 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).
Fecal gut microbiota — 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).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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