AzTrials
AzTrials

Obese AdultsSVTNCT07729215

Evaluation of the Effects of Systemic Vibration Therapy on Thermogenesis, Cardiovascular Parameters, Endocrine-inflammatory Markers, and Physical-functional Performance in Adults With Obesity.

A study testing Systemic vibratory therapy and Systemic vibration therapy in people with Obese Adults, run by Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this clinical trial was to evaluate the effects of Systemic Vibration Therapy (SVT) on thermogenesis, cardiovascular health, endocrine-inflammatory markers, and physical performance in adults (men and women, aged 18-59) with obesity. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Obese Adults
What is being tested?
Systemic vibratory therapy and Systemic vibration therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteBrazil
Study dates
31 Oct 2024to 31 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

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 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Individuals aged 18 to 59 years;
  • Both sexes;
  • Diagnosis of obesity, defined as a body mass index (BMI) ≥ 30 kg/m²;
  • Waist-to-height ratio (≥ 0.50).

Who cannot join

  • Presence of metallic prostheses;
  • Presence of a pacemaker;
  • Uncontrolled and untreated hypertension (≥180/120 mmHg);
  • History of labyrinthitis;
  • Previous diagnosis of deep vein thrombosis;
  • Pregnancy;
Show all 9Show fewer
  • Recent surgery (within the previous 6 months);
  • Neurodegenerative, pulmonary, or infectious diseases;
  • Inability to undergo the proposed assessments and/or interventions.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Laboratório de Vibrações Mecânicas e Práticas Integrativas - Policlínica Universitária Piquet Carneiro

    Rio de Janeiro, Rio de Janeiro, 20950-003

Other trials in Brazil

About this study

The goal of this clinical trial was to evaluate the effects of Systemic Vibration Therapy (SVT) on thermogenesis, cardiovascular health, endocrine-inflammatory markers, and physical performance in adults (men and women, aged 18-59) with obesity. The main questions it aimed to answer were:

What were the effects of SVT on thermogenesis and physical-functional performance in people with obesity?

Read more

How did SVT affect cardiovascular risk, hormone levels, and inflammation?

Researchers compared two types of vibrating platforms (vertical and side-alternating) to a placebo group (where the platform was turned off but simulated the sound) to see if the vibration led to changes in these health parameters.

Participants:

Attended sessions 2 times per week for either 6 or 12 weeks.

Stood barefoot in a static squat position on a vibrating platform for 29 minutes per session (alternating 1 minute of vibration with 1 minute of rest).

Underwent health assessments, including blood tests, body composition scans, muscle strength tests, and quality of life questionnaires.

Read the detailed description

Obesity is characterized by the excessive accumulation of body fat and triggers systemic impacts. Currently, it affects 1 in 8 people worldwide, with projections of generating global costs of US$ 3 trillion per year by 2030. In Brazil, prevalence may reach 30.4%. Central obesity is associated with chronic inflammation, insulin resistance, metabolic dysfunctions, and an increased risk of cardiovascular diseases (CVD), which are the leading causes of death globally. Low-grade inflammation and alterations in the autonomic nervous system also exacerbate cardiovascular risk. In this context, brown adipose tissue, with its thermogenic function, has been studied as a potential ally in body mass control. Excess fat combined with muscle mass loss accentuates functional impairments. Although physical exercise is essential, low adherence among individuals with obesity requires viable alternatives. Systemic vibration therapy (SVT), which utilizes mechanical vibrations through vibrating platforms, emerges as a promising strategy, with evidence of effects on reducing body fat, increasing muscle strength, and modulating hormonal and neuromuscular responses. However, conclusive evidence regarding the best protocols is lacking, justifying further studies.This study aims to evaluate the effects of SVT on thermogenesis, cardiovascular, endocrine-inflammatory parameters, and the physical-functional performance of adults with obesity by applying different protocols. Individuals aged 18 to 59 of both sexes, with a BMI ≥ 30 kg/m² and WHR ≥ 0.50, will be included. Recruitment will take place at HUPE, PPC/UERJ, the general community, and social media. The sample size calculation indicated a need for 30 participants, accounting for potential dropouts. Personal information will be collected, and biochemical, endocrine-inflammatory, vascular, cardiovascular risk, body composition, muscle strength, electromyography, physical-functional tests, eating behavior, quality of life, cognition, sleep, vital signs, and perceived exertion assessments will be performed.Interventions will occur twice a week, with a 72-hour interval, for 6 and 12 weeks. Two types of vibrating platforms will be used: vertical displacement (VVP) and side-alternating displacement (AVP). Three protocols will be applied: the GAVP will use the AVP with a frequency of 30 Hz and an amplitude of 2.5 mm or 5.0 mm; the GVVP will use the VVP, also at 30 Hz with "low" amplitude; and the SG (Sham Group) will perform the same movements with the platform turned off, simulating the vibration sound. In all groups, participants will be barefoot, in a static squat with knees at $50^\circ$, for 1 minute of exposure followed by 1 minute of rest, repeated 15 times, totaling 29 minutes per session.

Conditions
Obese Adults
Being tested
Systemic vibratory therapy, Systemic vibration therapy
Keywords
whole-body vibration, systemic vibratory therapy, obesity, functionality, cardiovascular risk, muscle strength, body composition, adults, anthropometry
Medical subject headings
Obesity

What participants receive

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

  • Systemic vibratory therapyDevice

    Also called vibrating platform

    The vertical displacement vibrating platform (Power Plate Pro 5, North America, Inc.) used features triplanar movement of its base (up and down, right and left, and forward and backward movements). However, the resultant of these movements is vertical; therefore, the individual felt as if it performed only the up and down movement while undergoing systemic vibration therapy. In this equipment, the frequency could be adjusted, and the amplitude was selected according to the chosen frequency, such as "high" or "low." The side-alternating displacement vibrating platform (KIKOS FITNESS, model P204IXC, São Paulo) that was used features base movements like a "seesaw," where the right side rises while the left side lowers and vice versa (in relation to the central fulcrum). On this equipment, the individual felt as if they were on a "seesaw." On this vibrating platform, the frequency could be adjusted, and the amplitude was selected according to the positioning of the individual's.

  • Systemic vibration therapyDevice

    Also called vibrating platform

    The individual was positioned barefoot, standing on the base of the side-alternating vibrating platform. The vibrating platform was turned off and coupled with a device that simulated the sound of mechanical vibration.

Study groups in NCT07729215
Study groupRoleWhat they receive
Side-Alternating Vibratory Platform Group (SAVPG)Active comparatorSystemic vibration therapy was performed on a vibrating platform with side-alternating displacement of the base, at a frequency of 30 Hz, with the peak-to-peak displacement adjusted to 2.5 mm or 5.0 mm. The individual was positioned barefoot, standing on the base of the vibrating platform, with the knees flexed at 50° (measured with a goniometer), in a static squat consisting of 1 minute of exposure to vibration followed by 1 minute of rest. This sequence was performed 15 times, totaling 29 minutes.
Receives: Device: Systemic vibratory therapy
Vertical Vibratory Platform Group (VVPG)Active comparatorSystemic vibration therapy was performed on a vibrating platform with vertical displacement of the base, and the individual was positioned barefoot, standing on the base of the vibrating platform with the knees flexed at 50° (measured with a goniometer), at a frequency of 30 Hz, with the amplitude adjusted to "low." The participant was positioned in a static squat, consisting of 1 minute of exposure to mechanical vibration followed by 1 minute of rest. This sequence was performed 15 times, totaling 29 minutes.
Receives: Device: Systemic vibratory therapy
Control group (CG)Placebo comparatorThe individual was positioned barefoot, standing on the base of the side-alternating vibrating platform, with the knees flexed at 50° (measured with a goniometer). The vibrating platform was turned off and coupled with a device that simulated the sound of mechanical vibration. The volunteer performed the simulation in a static squat, consisting of 1 minute of exposure with the device turned on followed by 1 minute of rest with the device turned off. This sequence was performed 15 times, totaling 29 minutes.
Receives: Device: Systemic vibration therapy

What is being measured

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

  1. Thermogenin

    Thermogenin (Uncoupling Protein 1 [UCP1]) was measured before and immediately after the WBV session. Blood samples were collected by a trained professional at the PPC/UERJ Clinical Analysis Laboratory (Capsule Unit), always during the same morning shift and no later than 8:00 a.m. For peripheral blood assays, serum and plasma collection tubes were centrifuged at 2,000 rpm at 25°C. Subsequently, 500 µL of serum was aliquoted into two microtubes and stored at -80°C until analysis. Serum UCP1 concentrations were determined using a specific enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions. Optical density (OD) was measured using a Thermo Scientific spectrophotometer.

    Measured: Baseline, Week 6, and Week 12

  2. Endocrine-inflammatory profile

    The endocrine-inflammatory profile was assessed by measuring Interleukin-1 beta (IL-1β), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin-6 (IL-6), Interleukin-8 (IL-8), Interleukin-10 (IL-10), Tumor Necrosis Factor-alpha (TNF-α), Soluble TNF Receptor Type I (sTNF-RI), Soluble TNF Receptor Type II (sTNF-RII), adiponectin, resistin, leptin, and irisin. Blood samples were collected by a trained professional at the PPC/UERJ Clinical Analysis Laboratory (Capsule Unit), always during the same morning shift and no later than 8:00 a.m. For peripheral blood assays, serum and plasma collection tubes were centrifuged at 2,000 rpm at 25°C. Subsequently, 500 µL of serum was aliquoted into two microtubes and stored at -80°C until analysis. Biomarker concentrations were determined using specific enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions. Optical density (OD) was measured using a Thermo Scientific spectrophotometer.

    Measured: Baseline, Week 6, and Week 12

Secondary outcomes (13)
  1. Total Body Water

    Total Body Water (TBW) was assessed using a tetrapolar bioelectrical impedance analyzer (InBody 370, BIOSPACE, Republic of Korea). The analyzer measured impedance across five body segments (right arm, left arm, trunk, right leg, and left leg) at three frequencies (5, 50, and 500 kHz) and provided segmental body composition measurements, including total body water.

    Unit of Measured: in liters (L).

    Measured: Baseline, Week 6, and Week 12

  2. Lean Body Mass, Fat Mass, and Skeletal Muscle Mass

    The measures of body composition were analyzed using a Tetrapolar Bioelectrical Impedance Analyzer (InBody 370, BIOSPACE, Republic of Korea). The analyzer measured impedance across five body segments (right arm, left arm, trunk, right leg, and left leg) using three different frequencies (5, 50, and 500 kHz) and provided separate body mass readings for each segment. The following body composition components were measured:

    Lean Body Mass: Measured in kilograms (kg).

    Fat Mass: Measured in kilograms (kg).

    Skeletal Muscle Mass: Measured in kilograms (kg).

    Measured: Baseline, Week 6, and Week 12.

  3. Body Fat Percentage

    The Body fat percentage of the body composition will be analyzed using a Tetrapolar Bioelectrical Impedance Analyzer (InBody 370, BIOSPACE, Republic of Korea). The analyzer performs impedance measurements across five body segments (right arm, left arm, trunk, right leg, and left leg) using three different frequencies (5, 50, and 500 kHz), and provides separate body mass readings for each segment.

    Unit of measure: Expressed as a percentage (%).

    Measured: Baseline, Week 6, and Week 12

  4. Basal Metabolic Rate

    Basal Metabolic Rate will be analyzed using a Tetrapolar Bioelectrical Impedance Analyzer (InBody 370, BIOSPACE, Republic of Korea). The analyzer performs impedance measurements across five body segments (right arm, left arm, trunk, right leg, and left leg) using three different frequencies (5, 50, and 500 kHz), and provides separate body mass readings for each segment. The device provides separate body mass readings for different body segments, being able to estimate the basal metabolic rate. The basal metabolic rate is directly proportional to the weight and amount of muscle. It was calculated from predictive formulas using the results of the body composition, and involves the data of age, sex and physical activity that is entered into the scale.

    Unit of measure: kilocalories per day (kcal/day).

    Measured: Baseline, Week 6, and Week 12

  5. Body Mass Index (BMI)

    Body Mass Index (BMI) is a clinical index that is used in bioimpedance to assess a person's weight. BMI is calculated by dividing the weight (in kg) by the height (in meters) squared.

    Unit of measure: kilograms per square meter (kg/m²).

    Measured: Baseline, Week 6, and Week 12

  6. Waist-to-Hip Ratio (WHR)

    The ratio of the circumference of the waist to the circumference of the hips, used as an indicator of cardiovascular risk. WHR was calculated by dividing the waist circumference in centimeters by the hip circumference. It is an element for the prognosis of cardiovascular events in adults. The cut-off index for cardiovascular risk is less than 0.85 for women and 0.90 for men. The unit of measurement is unitless.

    Unit of measure: kilograms per square meter (kg/m²).

    Measured: Baseline, Week 6, and Week 12

  7. Waist-to-Height Ratio (WHtR)

    The ratio of the circumference of the waist to height, used as an indicator of metabolic and cardiovascular risk. Height was measured using a vertical stadiometer graduated in centimeters and millimeters. Waist circumference was assessed using a tape measure graduated in centimeters and millimeters. The tape measure was placed midway between the iliac crest and the last rib. This anatomical point has the strongest correlation with abdominal adiposity. The values obtained were stratified into three categories: between 0.40 and 0.44 (lowest % fat, below the risk threshold); between 0.45 and 0.50 (moderate risk); between 0.50 and 0.56 (above the risk threshold). The unit of measurement is unitless.

    Measured: Baseline, Week 6, and Week 12

  8. Conicity Index (CI)

    Conicity index is a measure of body fat distribution, particularly visceral fat, calculated using body circumference measurements. The C Index (CI) was determined based on the measurement of body mass, height and waist circumference, in meters, representing an indicator of abdominal obesity, and is based on the principle that some people accumulate fat around the abdomen, with the consequent change in body shape. This index is calculated using the formula:

    C Index = waist circumference (m)/(0.109 x (√ body mass (kg)/height (m))).

    For the classification of cardiovascular risk, values ≥ 1.18 for women and ≥ 1.25 for men are determined. The unit of measurement is unitless.

    Measured: Baseline, Week 6, and Week 12

  9. Anthropometric measures

    Anthropometric measurements, as circumferences were assessed to evaluate the distribution of fat and other physical characteristics. The circumference measurements will be taken at the following sites, measured in centimeters (cm): neck, waist, hip, arm, and calf.

    Measured: Baseline, Week 6, and Week 12

  10. Functionality

    The Timed Up and Go (TUG) test was used to assess functional mobility and dynamic balance. Participants were instructed to stand up from a standard chair, walk 3 m at their usual pace, turn around, walk back to the chair, and sit down. The time required to complete the test was recorded in seconds, with shorter completion times indicating better functional mobility and dynamic balance.

    Measured: Baseline, Week 6, and Week 12

  11. Body Shape Index (ABSI)

    A Body Shape Index (ABSI) was used to assess body shape by considering waist circumference adjusted for body mass index (BMI) and height. Higher ABSI values indicate greater central adiposity and increased health risk. The cutoff values adopted were 0.0805 for women and 0.0828 for men.

    Measured: Baseline, week 6, and week 12

  12. Health-related quality of life

    Each participant completed the 36-Item Short Form Health Survey (SF-36) before the first and after the last intervention session. The SF-36 is a 36-item questionnaire that assesses health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100, with higher scores indicating better perceived health status and quality of life.

    Measured: Baseline, week 6, and week 12

  13. Muscle strength

    Handgrip strength was assessed using a Lafayette Hand Dynamometer (Model J00105). Participants were seated with their feet flat on the floor, the shoulder adducted, the elbow flexed at 90°, the forearm in a neutral position, and the wrist extended between 0° and 30°. Three maximal isometric grip contractions, each lasting 3 seconds, were performed with a 60-second rest interval between trials. The highest value recorded was used for analysis.

    Isometric lower limb muscle strength was assessed using a Lafayette digital dynamometer (Model 01165A). Hip flexion, hip extension, hip external rotation, knee flexion, and knee extension were evaluated through maximal voluntary isometric contractions performed in standardized positions. Stabilization straps were used during testing to minimize compensatory movements and improve measurement reliability. Three trials were performed for each movement, and the mean value was used for analysis.

    Measured: Baseline, week , and week 12

Timeline

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

  1. First posted27 Jul 2026
  2. Study start31 Oct 2024
  3. Primary completion31 Jan 2026
  4. Study completion31 Jan 2026

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07729215
Sponsor's protocol ID
90160825.6.0000.5259
Acronym
SVT
Status last verified
Jul 2026
First submitted
22 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD supporting the results in publications will be utilized.

Questions about this trial

What is this clinical trial studying?

A study testing Systemic vibratory therapy and Systemic vibration therapy in people with Obese Adults, run by Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas at 1 site in Brazil.

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 4 inclusion and 9 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: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Thermogenin (time frame: Baseline, Week 6, and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in