Whole Body Vibration After Bariatric Surgery
- Conditions
- Bariatric Surgery and Whole Body Vibration TrainingBariatric Surgery
- Interventions
- Device: Whole body vibration training
- Registration Number
- NCT05695599
- Lead Sponsor
- Universidad de Zaragoza
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whole body vibration Whole body vibration training Participants will undergo a whole body vibration training
- Primary Outcome Measures
Name Time Method 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).
Bone mineral density 18 months post-surgery Bone density measured with dual energy x-ray
Body composition 18 months post-surgery Body fat and visceral adipose tissue measured with Dual energy X-ray
Bone structure 18 months post-surgery Radius strength and structure measured with peripheral quantitative computed tomography
- Secondary Outcome Measures
Name Time Method Insulin resistance pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery HOMA test and insulin levels
Albumin levels pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery Serum albumin levels
International normalised ratio test pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery INR coagulation
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.
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
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.
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)
Basal metabolic rate pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery Basal metabolic rate
Frailty status pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery SPPB measures
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
Liver function (ALT) pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery Alanine transaminase levels
Liver function (bilirubin) pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery Serum bilirubin levels
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)
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
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
Liver function (GGT) pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery Gamma-glutamyl transferase
Calcium pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery Plasma calcium levels
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
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
Gait kinematics pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery Gait kinematics measured with inertial sensors
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
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
Hydroxyvitamin D pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery Plasma Hydroxyvitamin D 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
Diet pre-surgery, 6 months post-surgery Diet will be assessed though a food frequency questionnaire
Kidney markers pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery Creatinine levels
Folic acid levels pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery Plasma folic acid 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
Depression, anxiety and stress questionnaire pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery Dass 21 scale
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
Trial Locations
- Locations (2)
GENUD Research group
🇪🇸Zaragoza, Spain
Hospital Clinic Universitario
🇪🇸Zaragoza, Spain