Whole Body Vibration After Bariatric Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery; Bariatric Surgery and Whole Body Vibration Training
• Intervention / Treatment: Device: Whole body vibration training

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Recruiting
    • GENUD Research group
    • Contact: Alejandro Gomez; Phone Number: +34876553755; Email: bruton@unizar.es
  • Zaragoza, Spain, 50012
    • Not yet recruiting
    • Hospital Clinic Universitario
    • Contact: Maria Pilar Irun, PhD; Email: mpirun.uit@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza
• Collaborators: 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)

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 6, 2025

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: WBVBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No