Whole Body Vibration After Bariatric Surgery

NCT05695599 | Active Not Recruiting

• 1 other identifier: WBVBS
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (15)

• Bone mineral density

  Bone density measured with dual energy x-ray

  pre-surgery

• Bone mineral density

  Bone density measured with dual energy x-ray

  2 months post-surgery

• Bone mineral density

  Bone density measured with dual energy x-ray

  6 months post-surgery

• Bone mineral density

  Bone density measured with dual energy x-ray

  18 months post-surgery

• Bone structure

  Radius strength and structure measured with peripheral quantitative computed tomography

  pre-surgery

• Bone structure

  Radius strength and structure measured with peripheral quantitative computed tomography

  2 months post-surgery

• Bone structure

  Radius strength and structure measured with peripheral quantitative computed tomography

  6 months post-surgery

• Bone structure

  Radius strength and structure measured with peripheral quantitative computed tomography

  18 months post-surgery

• Body composition

  Body fat and visceral adipose tissue measured with Dual energy X-ray

  pre-surgery

• Body composition

  Body fat and visceral adipose tissue measured with Dual energy X-ray

  2 months post-surgery

• Body composition

  Body fat and visceral adipose tissue measured with Dual energy X-ray

  6 months post-surgery

• Body composition

  Body fat and visceral adipose tissue measured with Dual energy X-ray

  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).

  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).

  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).

  18 months post-surgery

Secondary Outcomes (39)

• Basal metabolic rate

  pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

• Heart rate variability

  pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

• Aerobic capacity

  pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

• Muscular strength of the upper limbs

  pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

• Muscular strength of the lower limbs

  pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

Study Arms (2)

Whole body vibration

EXPERIMENTAL

Participants will undergo a whole body vibration training

Device: Whole body vibration training

Control Group

NO INTERVENTION

Participants will not perform an intervention

Interventions

Whole body vibration training DEVICE

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

Also known as: Exercise

Whole body vibration

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD): collaborator
• Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBEROBN): collaborator

Study Sites (2)

GENUD Research group

Zaragoza, 50009, Spain

Location

Hospital Clinic Universitario

Zaragoza, 50012, Spain

Location

Related Publications (1)

• 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.

  PMID: 38926901 DERIVED

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will only have codes but in the database but will not know which code corresponds to which group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 25, 2023
• Study Start: April 23, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 6, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)