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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05695599
Other study ID # WBVBS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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