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NCT Number: NCT05695599

Whole Body Vibration 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.

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Key information

Conditions

Bariatric Surgery and Whole Body Vibration Training Bariatric Surgery

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GENUD Research group, Zaragoza, Spain

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole body vibration training

Device

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

Other names: Exercise

Primary outcomes

  1. Bone mineral density

    Time frame: pre-surgery

    Bone density measured with dual energy x-ray

  2. Bone mineral density

    Time frame: 2 months post-surgery

    Bone density measured with dual energy x-ray

  3. Bone mineral density

    Time frame: 6 months post-surgery

    Bone density measured with dual energy x-ray

  4. Bone mineral density

    Time frame: 18 months post-surgery

    Bone density measured with dual energy x-ray

  5. Bone structure

    Time frame: pre-surgery

    Radius strength and structure measured with peripheral quantitative computed tomography

  6. Bone structure

    Time frame: 2 months post-surgery

    Radius strength and structure measured with peripheral quantitative computed tomography

  7. Bone structure

    Time frame: 6 months post-surgery

    Radius strength and structure measured with peripheral quantitative computed tomography

  8. Bone structure

    Time frame: 18 months post-surgery

    Radius strength and structure measured with peripheral quantitative computed tomography

  9. Body composition

    Time frame: pre-surgery

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

  10. Body composition

    Time frame: 2 months post-surgery

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

  11. Body composition

    Time frame: 6 months post-surgery

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

  12. Body composition

    Time frame: 18 months post-surgery

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

  13. Fecal gut microbiota

    Time frame: pre-surgery

    Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample).

  14. Fecal gut microbiota

    Time frame: 6 months post-surgery

    Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample).

  15. Fecal gut microbiota

    Time frame: 18 months post-surgery

    Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample).

Secondary outcomes

  1. Basal metabolic rate

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Basal metabolic rate

  2. Heart rate variability

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Heart rate variability measured in fasting and resting conditions

  3. Aerobic capacity

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Bruce protocol on a treadmill

  4. Muscular strength of the upper limbs

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Measured with a handgrip dynamometer

  5. Muscular strength of the lower limbs

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Measured with the stand and sit chair test

  6. Agility

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    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.

  7. Balance

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

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

  8. Gait kinematics

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Gait kinematics measured with inertial sensors

  9. Frailty status

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    SPPB measures

  10. Quality of life of participants SF36

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Quality of life measured with the SF36

  11. Quality of life of participants EUROQOL 5Q

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Quality of life measured with the EUROQOL 5Q

  12. Pain scale

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Pain measured with the WOMAC questionnaire

  13. Objective physical activity levels

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

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

  14. Physical activity levels

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Physical activity levels measures with IPAQ-short

  15. Ankle range of motion

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Measurement of dorsiflexion and plantar flexion

  16. Inflammatory markers

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Interleukin 6, TNF alpha, and reactive C protein

  17. Blood glucose

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Glucose levels

  18. Cholesterol

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Blood cholesterol levels (LDL and HDL)

  19. Insulin resistance

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    HOMA test and insulin levels

  20. Kidney markers

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Creatinine levels

  21. Liver function (ALT)

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Alanine transaminase levels

  22. Liver function (AST)

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Aspartate transaminase

  23. Liver function (ALP)

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Alkaline phosphatase

  24. Liver function (GGT)

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Gamma-glutamyl transferase

  25. Liver function (bilirubin)

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Serum bilirubin levels

  26. International normalised ratio test

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    INR coagulation

  27. Albumin levels

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Serum albumin levels

  28. Iron metabolism

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Iron metabolism markers

  29. Vitamin B12 levels

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Plasma vitamin B12 levels

  30. Folic acid levels

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Plasma folic acid levels

  31. Hydroxyvitamin D

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Plasma Hydroxyvitamin D levels

  32. Calcium

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Plasma calcium levels

  33. Phosphorus

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Plasma phosphorus levels

  34. Parathyroid hormone

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Parathyroid hormone plasma levels

  35. Bone alkaline phosphatase

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Bone alkaline phosphatase plasma levels

  36. Leptin

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Leptin plasma levels

  37. Adinopectin

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Adinopectin plasma levels

  38. Diet

    Time frame: pre-surgery, 6 months post-surgery

    Diet will be assessed though a food frequency questionnaire

  39. Depression, anxiety and stress questionnaire

    Time frame: pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery

    Dass 21 scale

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 25, 2023
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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