Bariatric Surgery, Bariatric Surgery and Whole Body Vibration Training
Conditions
Brief 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.
Interventions
DEVICEWhole body vibration training
3 times per week of 20 to 30 minute sessions during 16 weeks of training
Sponsors
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD)
Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBEROBN)
Universidad de Zaragoza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician will only have codes but in the database but will not know which code corresponds to which group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density | pre-surgery | Bone density measured with dual energy x-ray |
| Bone structure | pre-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 |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscular strength of the lower limbs | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Measured with the stand and sit chair test |
| Agility | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | 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. |
| Balance | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Measured with the SPPB battery in three different position (feet together, tandem, semi tandem) |
| Gait kinematics | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Gait kinematics measured with inertial sensors |
| Frailty status | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | SPPB measures |
| Quality of life of participants SF36 | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Quality of life measured with the SF36 |
| Quality of life of participants EUROQOL 5Q | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Quality of life measured with the EUROQOL 5Q |
| Pain scale | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Pain measured with the WOMAC questionnaire |
| Objective physical activity levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Physical activity levels registered with triaxial accelerometers that they will wear during 7 days. |
| Physical activity levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Physical activity levels measures with IPAQ-short |
| Ankle range of motion | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Measurement of dorsiflexion and plantar flexion |
| Inflammatory markers | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Interleukin 6, TNF alpha, and reactive C protein |
| Blood glucose | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Glucose levels |
| Cholesterol | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Blood cholesterol levels (LDL and HDL) |
| Insulin resistance | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | HOMA test and insulin levels |
| Kidney markers | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Creatinine levels |
| Liver function (ALT) | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Alanine transaminase levels |
| Liver function (AST) | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Aspartate transaminase |
| Liver function (ALP) | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Alkaline phosphatase |
| Liver function (GGT) | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Gamma-glutamyl transferase |
| Liver function (bilirubin) | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Serum bilirubin levels |
| International normalised ratio test | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | INR coagulation |
| Albumin levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Serum albumin levels |
| Iron metabolism | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Iron metabolism markers |
| Vitamin B12 levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Plasma vitamin B12 levels |
| Folic acid levels | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Plasma folic acid levels |
| Hydroxyvitamin D | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Plasma Hydroxyvitamin D levels |
| Calcium | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Plasma calcium levels |
| Phosphorus | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Plasma phosphorus levels |
| Parathyroid hormone | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Parathyroid hormone plasma levels |
| Bone alkaline phosphatase | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Bone alkaline phosphatase plasma levels |
| Leptin | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Leptin plasma levels |
| Adinopectin | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Adinopectin plasma levels |
| Basal metabolic rate | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Basal metabolic rate |
| Depression, anxiety and stress questionnaire | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Dass 21 scale |
| Diet | pre-surgery, 6 months post-surgery | Diet will be assessed though a food frequency questionnaire |
| Heart rate variability | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Heart rate variability measured in fasting and resting conditions |
| Aerobic capacity | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Bruce protocol on a treadmill |
| Muscular strength of the upper limbs | pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery | Measured with a handgrip dynamometer |
Countries
Spain
Outcome results
None listed