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Whole Body Vibration After Bariatric Surgery

NCT ID: NCT05695599

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-23

Study Completion Date

2026-07-06

Brief Summary

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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.

Detailed Description

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Conditions

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Bariatric Surgery and Whole Body Vibration Training Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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Study Groups

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Whole body vibration

Participants will undergo a whole body vibration training

Group Type EXPERIMENTAL

Whole body vibration training

Intervention Type DEVICE

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

Control Group

Participants will not perform an intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Whole body vibration training

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

Intervention Type DEVICE

Other Intervention Names

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Exercise

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

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José A. Casajús

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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GENUD Research group

Zaragoza, , Spain

Site Status

Hospital Clinic Universitario

Zaragoza, , Spain

Site Status

Countries

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Spain

References

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Gomez-Bruton A, Irun P, Matute-Llorente A, Lozano-Berges G, Moradell A, Ara-Gimeno S, Subias-Perie J, Sanchez-Luengo M, Hijos-Mallada G, Garcia-Mateo S, Arechavaleta S, Palacios Fanlo MJ, Lanas A, Casajus JA. Effects of whole-body vibration on body composition, microbiota, cardiometabolic markers, physical fitness, and quality of life after bariatric surgery: protocol for a randomized controlled trial. Trials. 2024 Jun 26;25(1):413. doi: 10.1186/s13063-024-08221-7.

Reference Type DERIVED
PMID: 38926901 (View on PubMed)

Other Identifiers

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WBVBS

Identifier Type: -

Identifier Source: org_study_id