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Completed

NCT Number: NCT07729215

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

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?

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Rio de Janeiro, 20950-003, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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;
  • Recent surgery (within the previous 6 months);
  • Neurodegenerative, pulmonary, or infectious diseases;
  • Inability to undergo the proposed assessments and/or interventions.

Treatment and study plan

Systemic vibratory therapy

Device

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.

Other names: vibrating platform

Systemic vibration therapy

Device

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.

Other names: vibrating platform

Primary outcomes

  1. Thermogenin

    Time frame: Baseline, Week 6, and Week 12

    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.

  2. Endocrine-inflammatory profile

    Time frame: Baseline, Week 6, and Week 12

    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.

Secondary outcomes

  1. Total Body Water

    Time frame: Baseline, Week 6, and Week 12

    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).

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

    Time frame: Baseline, Week 6, and Week 12.

    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).

  3. Body Fat Percentage

    Time frame: Baseline, Week 6, and Week 12

    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 (%).

  4. Basal Metabolic Rate

    Time frame: Baseline, Week 6, and Week 12

    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).

  5. Body Mass Index (BMI)

    Time frame: Baseline, Week 6, and Week 12

    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).

  6. Waist-to-Hip Ratio (WHR)

    Time frame: Baseline, Week 6, and Week 12

    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).

  7. Waist-to-Height Ratio (WHtR)

    Time frame: Baseline, Week 6, and Week 12

    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.

  8. Conicity Index (CI)

    Time frame: Baseline, Week 6, and Week 12

    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.

  9. Anthropometric measures

    Time frame: Baseline, Week 6, and Week 12

    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.

  10. Functionality

    Time frame: Baseline, Week 6, and Week 12

    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.

  11. Body Shape Index (ABSI)

    Time frame: Baseline, week 6, and week 12

    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.

  12. Health-related quality of life

    Time frame: Baseline, week 6, and week 12

    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.

  13. Muscle strength

    Time frame: Baseline, week , and week 12

    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.

Sponsors and collaborators

Lead sponsor

Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)
  • Rio de Janeiro State University

Registry information

Acronym: SVT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

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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