Clinical trial NCT05695599: Whole Body Vibration After Bariatric Surgery
Official title: Supervised Whole Body Vibration Training for the Improvement of Body Composition, Microbiota and Physical Fitness After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bariatric Surgery and Whole Body Vibration Training
Bariatric Surgery
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD)
name: Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBEROBN)
First posted: 2023-01-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bone mineral density
timeFrame: pre-surgery
measure: Bone mineral density
timeFrame: 2 months post-surgery
measure: Bone mineral density
timeFrame: 6 months post-surgery
measure: Bone mineral density
timeFrame: 18 months post-surgery
measure: Bone structure
timeFrame: pre-surgery
measure: Bone structure
timeFrame: 2 months post-surgery
measure: Bone structure
timeFrame: 6 months post-surgery
measure: Bone structure
timeFrame: 18 months post-surgery
measure: Body composition
timeFrame: pre-surgery
measure: Body composition
timeFrame: 2 months post-surgery
measure: Body composition
timeFrame: 6 months post-surgery
measure: Body composition
timeFrame: 18 months post-surgery
measure: Fecal gut microbiota
timeFrame: pre-surgery
measure: Fecal gut microbiota
timeFrame: 6 months post-surgery
measure: Fecal gut microbiota
timeFrame: 18 months post-surgery
Secondary outcomes:
measure: Basal metabolic rate
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Heart rate variability
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Aerobic capacity
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Muscular strength of the upper limbs
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Muscular strength of the lower limbs
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Agility
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Balance
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Gait kinematics
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Frailty status
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Quality of life of participants SF36
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Quality of life of participants EUROQOL 5Q
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Pain scale
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Objective physical activity levels
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Physical activity levels
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Ankle range of motion
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Inflammatory markers
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Blood glucose
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Cholesterol
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Insulin resistance
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Kidney markers
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Liver function (ALT)
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Liver function (AST)
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Liver function (ALP)
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Liver function (GGT)
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Liver function (bilirubin)
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: International normalised ratio test
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Albumin levels
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Iron metabolism
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Vitamin B12 levels
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Folic acid levels
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Hydroxyvitamin D
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Calcium
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Phosphorus
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Parathyroid hormone
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Bone alkaline phosphatase
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Leptin
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Adinopectin
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
measure: Diet
timeFrame: pre-surgery, 6 months post-surgery
measure: Depression, anxiety and stress questionnaire
timeFrame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: GENUD Research group
city: Zaragoza
country: Spain
facility: Hospital Clinic Universitario
Study officials:
References: