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NCT06907108Completed

Evaluation of Clinical, Metabolic, and Physical-functional Effects of Systemic Vibratory Therapy in Metabolic Syndrome

Clinical, Metabolic, Physical, Functional, Biochemical, Quality of Life, and Quality of Sleep Evaluation in Individuals With Metabolic Syndrome After Performing Systemic Vibratory Therapy on an Oscillating/Vibrating Platform

Source: ClinicalTrials.gov · Last updated 2 Apr 2025

Brief summary (registry, in English)

Studies have demonstrated a strong relationship between physical inactivity and the presence of cardiovascular risk factors such as hypertension, insulin resistance, diabetes, dyslipidemia, obesity, and metabolic syndrome. On the other hand, regular physical exercise has been recommended to prevent and treat cardiovascular diseases, their risk factors, and other chronic conditions. Systemic vibration therapy (SVT) has been proposed as an alternative exercise modality for this population. This project aimed to assess clinical, metabolic, physical, functional, biochemical parameters, quality of life, and sleep quality in individuals with metabolic syndrome undergoing whole-body vibration exercises on a vibratory platform. This study aimed to evaluate clinical, metabolic, physical-functional, biochemical parameters, quality of life, and sleep quality in individuals with MSy undergoing whole-body vibration exercises. Assessments were conducted before and after the intervention and included cardiovascular responses, dyspnea, fatigue, anthropometric measurements (neck, abdominal, hip, arm, and ankle circumferences), body composition, anterior trunk and lumbar spine flexibility, and laboratory analyses (complete blood count, cholesterol profile, triglycerides, creatinine, uric acid, cortisol, glucose, insulin, growth hormone, vitamin D, and other biomarkers). Questionnaires assessed quality of life and sleep. Neuromuscular function, handgrip strength, lower limb isometric dynamometry, joint goniometry, and functional tests were evaluated. Participants were randomized into two SVT protocol groups: Fixed Frequency (FF) and Variable Frequency (VF). Both protocols were conducted on a vibratory platform with alternating base displacement. In the FF group, a frequency of 5 Hz was applied, with peak-to-peak displacements of 2.5, 5.0, and 7.5 mm, a work time of 1 minute (10s "on" and 50s "off"), and 1 minute of rest in an upright position. In the VF group, frequencies varied from 5 to 16 Hz (increasing by 1 Hz per session), with a work time of 1 minute and 1 minute of rest, while peak-to-peak displacements remained the same as in the FF protocol. The protocols were performed in static and dynamic squat positions, twice a week, over six weeks, totaling 12 sessions. It is expected that this vibratory platform intervention can improve clinical, physical, biochemical, and functional parameters, as well as quality of life and sleep quality in individuals with MSy.

Status (registry)
Completed
Study type
Interventional
Enrollment
56 (actual)
First submitted
7 Mar 2025
Start date
1 Nov 2020
Primary completion date
30 Apr 2024
Lead sponsor
Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas
Diseases
Obesity
NCT number
NCT06907108

What you commit to

  • Study type: Interventional
  • Participants enrolled: 56
  • From 1 Nov 2020 to the primary completion date, 30 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Uncontrolled untreated hypertension, with elevated systemic blood pressure levels (≥180 x 110 mmHg);
  • History of a cardiovascular event (myocardial infarction/stroke) in the last 6 months;
  • Deep vein thrombosis while taking medication (6 months);
  • History of recent surgery on the lower limbs or spine (within 1 year);
  • Neurological, rheumatological, or osteomyoarticular disorders;
  • Severe or disabling diseases; individuals with metallic prostheses;
  • Infectious, neurodegenerative, or pulmonary diseases;

Other

  • Individuals unable to undergo the proposed assessments and/or interventions;
  • Individuals who discontinued the intervention (more than three consecutive absences from sessions);
  • Individuals presenting any contraindication to the vibratory platform.

Who the study is looking for

  • Individuals with a confirmed diagnosis of Metabolic Syndrome according to the International Diabetes Federation criteria;
  • Aged over 45 years,
  • Both sexes.

Age in the registry: 45 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Laboratório de Vibrações Mecânicas e Práticas Integrativas - Policlínica Universitária Piquet Carneiro
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.