Viewing Study NCT05695599



Ignite Creation Date: 2024-05-06 @ 6:32 PM
Last Modification Date: 2024-10-26 @ 2:50 PM
Study NCT ID: NCT05695599
Status: RECRUITING
Last Update Posted: 2023-05-26
First Post: 2022-12-19

Brief Title: Whole Body Vibration After Bariatric Surgery
Sponsor: Universidad de Zaragoza
Organization: Universidad de Zaragoza

Study Overview

Official Title: Supervised Whole Body Vibration Training for the Improvement of Body Composition Microbiota and Physical Fitness After Bariatric Surgery
Status: RECRUITING
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Morbid obesity is defined as a complex chronic condition in which a person presents a body mass index above 40 kgm2 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None