Clinical Trial

Whole Body Vibration After Bariatric Surgery

Active, Not Recruiting
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Record status
This record was last updated December 10, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-01-19; most recent amendment 2024-12-04.
Status change: Recruiting → Active, Not Recruiting 2024-12-04
Status change: Not Yet Recruiting → Recruiting 2023-05-25
Trial Details
NCT Number NCT05695599
Lead Sponsor Universidad de Zaragoza
Collaborators: Consorcio Centro de Investigación Biomédica en Red (CIBER), Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición
Conditions Bariatric Surgery and Whole Body Vibration Training, Bariatric Surgery
Enrollment 28 participants
Start Date 2023-04-23
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-07-06 (estimated)
Updated on ClinicalTrials.gov 2024-12-10