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Bariatric Surgery and Whole Body Vibration TrainingNCT05695599

Whole Body Vibration After Bariatric Surgery

A study testing Whole body vibration training in people with Bariatric Surgery and Whole Body Vibration Training and Bariatric Surgery, run by Universidad de Zaragoza at 2 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Whole body vibration training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesSpain
Study dates
23 Apr 2023to 6 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • GENUD Research group

    Zaragoza, 50009

  • Hospital Clinic Universitario

    Zaragoza, 50012

Other trials in Spain

About this study

Official title: Supervised Whole Body Vibration Training for the Improvement of Body Composition, Microbiota and Physical Fitness After Bariatric Surgery

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.

Being tested
Whole body vibration training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole body vibration trainingDevice

    Also called Exercise

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

Study groups in NCT05695599
Study groupRoleWhat they receive
Whole body vibrationExperimentalParticipants will undergo a whole body vibration training
Receives: Device: Whole body vibration training
Control GroupNo interventionParticipants will not perform an intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone mineral density

    Bone density measured with dual energy x-ray

    Measured: pre-surgery

  2. Bone mineral density

    Bone density measured with dual energy x-ray

    Measured: 2 months post-surgery

  3. Bone mineral density

    Bone density measured with dual energy x-ray

    Measured: 6 months post-surgery

  4. Bone mineral density

    Bone density measured with dual energy x-ray

    Measured: 18 months post-surgery

  5. Bone structure

    Radius strength and structure measured with peripheral quantitative computed tomography

    Measured: pre-surgery

  6. Bone structure

    Radius strength and structure measured with peripheral quantitative computed tomography

    Measured: 2 months post-surgery

  7. Bone structure

    Radius strength and structure measured with peripheral quantitative computed tomography

    Measured: 6 months post-surgery

  8. Bone structure

    Radius strength and structure measured with peripheral quantitative computed tomography

    Measured: 18 months post-surgery

  9. Body composition

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

    Measured: pre-surgery

  10. Body composition

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

    Measured: 2 months post-surgery

  11. Body composition

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

    Measured: 6 months post-surgery

  12. Body composition

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

    Measured: 18 months post-surgery

  13. 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).

    Measured: pre-surgery

  14. 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).

    Measured: 6 months post-surgery

  15. 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).

    Measured: 18 months post-surgery

Secondary outcomes (39)

  1. Basal metabolic rate

    Basal metabolic rate

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

  2. Heart rate variability

    Heart rate variability measured in fasting and resting conditions

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

  3. Aerobic capacity

    Bruce protocol on a treadmill

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

  4. Muscular strength of the upper limbs

    Measured with a handgrip dynamometer

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

  5. Muscular strength of the lower limbs

    Measured with the stand and sit chair test

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

  6. Agility

    Measured with the time up and go test. Sitting on a chair the participant has to stand up and walk 2,4 meters forward, turn and sit back on the chair.

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

  7. Balance

    Measured with the SPPB battery in three different position (feet together, tandem, semi tandem)

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

  8. Gait kinematics

    Gait kinematics measured with inertial sensors

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

  9. Frailty status

    SPPB measures

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

  10. Quality of life of participants SF36

    Quality of life measured with the SF36

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

  11. Quality of life of participants EUROQOL 5Q

    Quality of life measured with the EUROQOL 5Q

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

  12. Pain scale

    Pain measured with the WOMAC questionnaire

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

  13. Objective physical activity levels

    Physical activity levels registered with triaxial accelerometers that they will wear during 7 days.

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

  14. Physical activity levels

    Physical activity levels measures with IPAQ-short

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

  15. Ankle range of motion

    Measurement of dorsiflexion and plantar flexion

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

  16. Inflammatory markers

    Interleukin 6, TNF alpha, and reactive C protein

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

  17. Blood glucose

    Glucose levels

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

  18. Cholesterol

    Blood cholesterol levels (LDL and HDL)

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

  19. Insulin resistance

    HOMA test and insulin levels

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

  20. Kidney markers

    Creatinine levels

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

  21. Liver function (ALT)

    Alanine transaminase levels

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

  22. Liver function (AST)

    Aspartate transaminase

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

  23. Liver function (ALP)

    Alkaline phosphatase

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

  24. Liver function (GGT)

    Gamma-glutamyl transferase

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

  25. Liver function (bilirubin)

    Serum bilirubin levels

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

  26. International normalised ratio test

    INR coagulation

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

  27. Albumin levels

    Serum albumin levels

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

  28. Iron metabolism

    Iron metabolism markers

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

  29. Vitamin B12 levels

    Plasma vitamin B12 levels

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

  30. Folic acid levels

    Plasma folic acid levels

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

  31. Hydroxyvitamin D

    Plasma Hydroxyvitamin D levels

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

  32. Calcium

    Plasma calcium levels

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

  33. Phosphorus

    Plasma phosphorus levels

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

  34. Parathyroid hormone

    Parathyroid hormone plasma levels

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

  35. Bone alkaline phosphatase

    Bone alkaline phosphatase plasma levels

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

  36. Leptin

    Leptin plasma levels

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

  37. Adinopectin

    Adinopectin plasma levels

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

  38. Diet

    Diet will be assessed though a food frequency questionnaire

    Measured: pre-surgery, 6 months post-surgery

  39. Depression, anxiety and stress questionnaire

    Dass 21 scale

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start23 Apr 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion6 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05695599
Sponsor's protocol ID
WBVBS
Status last verified
Dec 2024
First submitted
19 Dec 2022
Last updated
10 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38926901

Questions about this trial

What is this clinical trial studying?

A study testing Whole body vibration training in people with Bariatric Surgery and Whole Body Vibration Training and Bariatric Surgery, run by Universidad de Zaragoza at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone mineral density (time frame: pre-surgery). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05695599, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024; AzTrials last refreshed its copy on 2 Nov 2026.

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