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Whole Body Vibration After Bariatric Surgery

NCT05695599 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-12-10

No results posted yet for this study

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.

Conditions

  • Bariatric Surgery and Whole Body Vibration Training
  • Bariatric Surgery

Interventions

DEVICE

Whole body vibration training

3 times per week of 20 to 30 minute sessions during 16 weeks of training

Sponsors & Collaborators

  • Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD)

    collaborator UNKNOWN

  • Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBEROBN)

    collaborator UNKNOWN

  • Universidad de Zaragoza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-23
Primary Completion
2025-12-31
Completion
2026-07-06

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05695599 on ClinicalTrials.gov