NCT07729215

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

July 22, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

whole-body vibrationsystemic vibratory therapyobesityfunctionalitycardiovascular riskmuscle strengthbody compositionadultsanthropometry

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, Week 6, and Week 12

  • 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.

    Baseline, Week 6, and Week 12

Secondary Outcomes (13)

  • Total Body Water

    Baseline, Week 6, and Week 12

  • Lean Body Mass, Fat Mass, and Skeletal Muscle Mass

    Baseline, Week 6, and Week 12.

  • Body Fat Percentage

    Baseline, Week 6, and Week 12

  • Basal Metabolic Rate

    Baseline, Week 6, and Week 12

  • Body Mass Index (BMI)

    Baseline, Week 6, and Week 12

  • +8 more secondary outcomes

Study Arms (3)

Side-Alternating Vibratory Platform Group (SAVPG)

ACTIVE COMPARATOR

Systemic 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.

Device: Systemic vibratory therapy

Vertical Vibratory Platform Group (VVPG)

ACTIVE COMPARATOR

Systemic 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.

Device: Systemic vibratory therapy

Control group (CG)

PLACEBO COMPARATOR

The 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.

Device: Systemic vibration therapy

Interventions

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.

Also known as: vibrating platform
Side-Alternating Vibratory Platform Group (SAVPG)Vertical Vibratory Platform Group (VVPG)

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.

Also known as: vibrating platform
Control group (CG)

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rio de Janeiro, Rio de Janeiro, 20950-003, Brazil

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start

October 31, 2024

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

All collected IPD supporting the results in publications will be utilized.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Available indefinitely
Access Criteria
Unending

Locations