Whole Body Vibration After Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Supervised Whole Body Vibration Training for the Improvement of Body Composition, Microbiota and Physical Fitness After Bariatric Surgery

Conditions
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Bariatric Surgery and Whole Body Vibration Training, Bariatric Surgery

Intervention / Treatment
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* Device: Whole body vibration training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole body vibration<br>Participants will undergo a whole body vibration training | Device: Whole body vibration training<br>* 3 times per week of 20 to 30 minute sessions during 16 weeks of training<br>* Other names: Exercise;|
| No Intervention: Control Group<br>Participants will not perform an intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density | Bone density measured with dual energy x-ray | pre-surgery | 
| Bone mineral density | Bone density measured with dual energy x-ray | 2 months post-surgery | 
| Bone mineral density | Bone density measured with dual energy x-ray | 6 months post-surgery | 
| Bone mineral density | Bone density measured with dual energy x-ray | 18 months post-surgery | 
| Bone structure | Radius strength and structure measured with peripheral quantitative computed tomography | pre-surgery | 
| Bone structure | Radius strength and structure measured with peripheral quantitative computed tomography | 2 months post-surgery | 
| Bone structure | Radius strength and structure measured with peripheral quantitative computed tomography | 6 months post-surgery | 
| Bone structure | Radius strength and structure measured with peripheral quantitative computed tomography | 18 months post-surgery | 
| Body composition | Body fat and visceral adipose tissue measured with Dual energy X-ray | pre-surgery | 
| Body composition | Body fat and visceral adipose tissue measured with Dual energy X-ray | 2 months post-surgery | 
| Body composition | Body fat and visceral adipose tissue measured with Dual energy X-ray | 6 months post-surgery | 
| Body composition | Body fat and visceral adipose tissue measured with Dual energy X-ray | 18 months post-surgery | 
| Fecal gut microbiota | Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample). | pre-surgery | 
| Fecal gut microbiota | Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample). | 6 months post-surgery | 
| Fecal gut microbiota | Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample). | 18 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal metabolic rate | Basal metabolic rate | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Heart rate variability | Heart rate variability measured in fasting and resting conditions | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Aerobic capacity | Bruce protocol on a treadmill | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Muscular strength of the upper limbs | Measured with a handgrip dynamometer | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Muscular strength of the lower limbs | Measured with the stand and sit chair test | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Agility | Measured with the time up and go test. Sitting on a chair the participant has to stand up and walk 2,4 meters forward, turn and sit back on the chair. | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Balance | Measured with the SPPB battery in three different position (feet together, tandem, semi tandem) | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Gait kinematics | Gait kinematics measured with inertial sensors | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Frailty status | SPPB measures | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Quality of life of participants SF36 | Quality of life measured with the SF36 | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Quality of life of participants EUROQOL 5Q | Quality of life measured with the EUROQOL 5Q | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Pain scale | Pain measured with the WOMAC questionnaire | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Objective physical activity levels | Physical activity levels registered with triaxial accelerometers that they will wear during 7 days. | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Physical activity levels | Physical activity levels measures with IPAQ-short | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Ankle range of motion | Measurement of dorsiflexion and plantar flexion | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Inflammatory markers | Interleukin 6, TNF alpha, and reactive C protein | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Blood glucose | Glucose levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Cholesterol | Blood cholesterol levels (LDL and HDL) | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Insulin resistance | HOMA test and insulin levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Kidney markers | Creatinine levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Liver function (ALT) | Alanine transaminase levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Liver function (AST) | Aspartate transaminase | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Liver function (ALP) | Alkaline phosphatase | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Liver function (GGT) | Gamma-glutamyl transferase | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Liver function (bilirubin) | Serum bilirubin levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| International normalised ratio test | INR coagulation | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Albumin levels | Serum albumin levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Iron metabolism | Iron metabolism markers | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Vitamin B12 levels | Plasma vitamin B12 levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Folic acid levels | Plasma folic acid levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Hydroxyvitamin D | Plasma Hydroxyvitamin D levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Calcium | Plasma calcium levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Phosphorus | Plasma phosphorus levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Parathyroid hormone | Parathyroid hormone plasma levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Bone alkaline phosphatase | Bone alkaline phosphatase plasma levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Leptin | Leptin plasma levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Adinopectin | Adinopectin plasma levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 
| Diet | Diet will be assessed though a food frequency questionnaire | pre-surgery, 6 months post-surgery | 
| Depression, anxiety and stress questionnaire | Dass 21 scale | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |