An interventional study of Whole body vibration training in Bariatric Surgery and Whole Body Vibration Training and Bariatric Surgery, sponsored by Universidad de Zaragoza. Active, not recruiting at 2 sites in Spain. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Universidad de Zaragoza · Not applicable, Interventional, and Treatment
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.
Universidad de Zaragoza is the lead sponsor of 109 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo a whole body vibration training
Device: Whole body vibration training
Participants will not perform an intervention
3 times per week of 20 to 30 minute sessions during 16 weeks of training
Also known as: Exercise
Bone mineral density
Bone density measured with dual energy x-ray
Time frame: pre-surgery
Bone mineral density
Bone density measured with dual energy x-ray
Time frame: 2 months post-surgery
Bone mineral density
Bone density measured with dual energy x-ray
Time frame: 6 months post-surgery
Bone mineral density
Bone density measured with dual energy x-ray
Time frame: 18 months post-surgery
Bone structure
Radius strength and structure measured with peripheral quantitative computed tomography
Time frame: pre-surgery
Bone structure
Radius strength and structure measured with peripheral quantitative computed tomography
Time frame: 2 months post-surgery
Bone structure
Radius strength and structure measured with peripheral quantitative computed tomography
Time frame: 6 months post-surgery
Bone structure
Radius strength and structure measured with peripheral quantitative computed tomography
Time frame: 18 months post-surgery
Body composition
Body fat and visceral adipose tissue measured with Dual energy X-ray
Time frame: pre-surgery
Body composition
Body fat and visceral adipose tissue measured with Dual energy X-ray
Time frame: 2 months post-surgery
Body composition
Body fat and visceral adipose tissue measured with Dual energy X-ray
Time frame: 6 months post-surgery
Body composition
Body fat and visceral adipose tissue measured with Dual energy X-ray
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 18 months post-surgery
Basal metabolic rate
Basal metabolic rate
Time frame: 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
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Aerobic capacity
Bruce protocol on a treadmill
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Gait kinematics
Gait kinematics measured with inertial sensors
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Frailty status
SPPB measures
Time frame: 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
Time frame: 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
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Pain scale
Pain measured with the WOMAC questionnaire
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Blood glucose
Glucose levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Cholesterol
Blood cholesterol levels (LDL and HDL)
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Insulin resistance
HOMA test and insulin levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Kidney markers
Creatinine levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Liver function (ALT)
Alanine transaminase levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Liver function (AST)
Aspartate transaminase
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Liver function (ALP)
Alkaline phosphatase
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Liver function (GGT)
Gamma-glutamyl transferase
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Liver function (bilirubin)
Serum bilirubin levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
International normalised ratio test
INR coagulation
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Albumin levels
Serum albumin levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Iron metabolism
Iron metabolism markers
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Vitamin B12 levels
Plasma vitamin B12 levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Folic acid levels
Plasma folic acid levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Hydroxyvitamin D
Plasma Hydroxyvitamin D levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Calcium
Plasma calcium levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Phosphorus
Plasma phosphorus levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Parathyroid hormone
Parathyroid hormone plasma levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Bone alkaline phosphatase
Bone alkaline phosphatase plasma levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Leptin
Leptin plasma levels
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Adinopectin
Adinopectin plasma levels
Time frame: 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
Time frame: pre-surgery, 6 months post-surgery
Depression, anxiety and stress questionnaire
Dass 21 scale
Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery
Plan to share: No
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Universidad de Zaragoza