Whole Body Vibration After Bariatric Surgery

Bariatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05695599
• Other study ID #: WBVBS
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2023
• Est. completion date: July 6, 2025

Study information

• Verified date: May 2023
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: July 6, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Device:
• Whole body vibration training
3 times per week of 20 to 30 minute sessions during 16 weeks of training

Locations

Country	Name	City	State
Spain	GENUD Research group	Zaragoza
Spain	Hospital Clinic Universitario	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Zaragoza	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)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density	Bone density measured with dual energy x-ray	pre-surgery
Primary	Bone mineral density	Bone density measured with dual energy x-ray	2 months post-surgery
Primary	Bone mineral density	Bone density measured with dual energy x-ray	6 months post-surgery
Primary	Bone mineral density	Bone density measured with dual energy x-ray	18 months post-surgery
Primary	Bone structure	Radius strength and structure measured with peripheral quantitative computed tomography	pre-surgery
Primary	Bone structure	Radius strength and structure measured with peripheral quantitative computed tomography	2 months post-surgery
Primary	Bone structure	Radius strength and structure measured with peripheral quantitative computed tomography	6 months post-surgery
Primary	Bone structure	Radius strength and structure measured with peripheral quantitative computed tomography	18 months post-surgery
Primary	Body composition	Body fat and visceral adipose tissue measured with Dual energy X-ray	pre-surgery
Primary	Body composition	Body fat and visceral adipose tissue measured with Dual energy X-ray	2 months post-surgery
Primary	Body composition	Body fat and visceral adipose tissue measured with Dual energy X-ray	6 months post-surgery
Primary	Body composition	Body fat and visceral adipose tissue measured with Dual energy X-ray	18 months post-surgery
Primary	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
Primary	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
Primary	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	Basal metabolic rate	Basal metabolic rate	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	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
Secondary	Aerobic capacity	Bruce protocol on a treadmill	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Gait kinematics	Gait kinematics measured with inertial sensors	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Frailty status	SPPB measures	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	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
Secondary	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
Secondary	Pain scale	Pain measured with the WOMAC questionnaire	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood glucose	Glucose levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Cholesterol	Blood cholesterol levels (LDL and HDL)	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Insulin resistance	HOMA test and insulin levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Kidney markers	Creatinine levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Liver function (ALT)	Alanine transaminase levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Liver function (AST)	Aspartate transaminase	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Liver function (ALP)	Alkaline phosphatase	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Liver function (GGT)	Gamma-glutamyl transferase	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Liver function (bilirubin)	Serum bilirubin levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	International normalised ratio test	INR coagulation	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Albumin levels	Serum albumin levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Iron metabolism	Iron metabolism markers	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Vitamin B12 levels	Plasma vitamin B12 levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Folic acid levels	Plasma folic acid levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Hydroxyvitamin D	Plasma Hydroxyvitamin D levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Calcium	Plasma calcium levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Phosphorus	Plasma phosphorus levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Parathyroid hormone	Parathyroid hormone plasma levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Bone alkaline phosphatase	Bone alkaline phosphatase plasma levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Leptin	Leptin plasma levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Adinopectin	Adinopectin plasma levels	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Secondary	Diet	Diet will be assessed though a food frequency questionnaire	pre-surgery, 6 months post-surgery
Secondary	Depression, anxiety and stress questionnaire	Dass 21 scale	pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery