Clinical trial NCT06907108: Evaluation of Clinical, Metabolic, and Physical-functional Effects of Systemic Vibratory Therapy in Metabolic Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Metabolic Syndrome Obesity
Metabolic Syndrome X
Keywords: whole-body vibration
systemic vibratory therapy
systemic vibration therapy
metabolic syndrome
functionality
quality of life
sleep quality
flexibility
blood parameters
anthropometry
body composition
cardiovascular responses
muscle strength
neuromuscular activation
pain level
Lead sponsor: Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Rio de Janeiro State University
First posted: 2025-04-02
Enrollment: 56
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: For anamnesis, participant data were collected, including age, sex, smoking status, alcohol consumption, presence and type of diabetes mellitus, presence of systemic arterial hypertension, associated comorbidities, medication use, history of COVID-19, and physical inactivity.

Clinical assessments were conducted before and after the 12 sessions of systemic vibratory therapy, including measurements of systemic blood pressure, heart rate, respiratory rate, the BORG scale, the Numeric Pain Scale (NPS), and the Rating of Perceived Exertion (RPE scale - subjective effort perception). Anthropometric measurements were collected, including neck, abdominal, hip, arm, and ankle circumferences, as well as body composition distribution assessed via bioelectrical impedance, anterior trunk flexibility via the sit-and-reach test (FAT), and lumbar spine flexibility via the Schober test.

Laboratory analyses of relevant biomarkers, the HOMA-IR index, and anthropometric indicators were also evaluated. Questionnaires were administered to assess quality of life and sleep quality.

Neuromuscular activity was assessed using surface electromyography, handgrip strength via a manual dynamometer, lower limb isometric dynamometry, joint goniometry, and functional tests. Patients were positioned on the platform base under the supervision of a healthcare professional to perform the interventions.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Glycated Hemoglobin (HbA1c)
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Lipid Profile and Fasting Blood Glucose
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Uric Acid Levels
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Hormonal Biomarkers
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Metabolic Biomarkers
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Total Body Water
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Lean Body Mass, Fat Mass, and Skeletal Muscle Mass
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Body Fat Percentage
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Visceral Fat Area
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Basal Metabolic Rate
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Body Mass Index (BMI)
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Waist-to-Hip Ratio (WHR)
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Waist-to-Height Ratio (WHtR)
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Conicity Index
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Anthropometric measures
timeFrame: From enrollment to the end of treatment at 6 weeks.
Secondary outcomes:
measure: Functionality
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Lumbar spine flexibility
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Anterior Trunk Flexion Test
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Health-related quality of life
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Epworth Sleepiness Scale (ESS)
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Mental health
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Physical activity
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Cardiovascular responses
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Neuromuscular activation
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Muscle strength
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Pain Level
timeFrame: From enrollment to the end of treatment at 6 weeks.
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Laboratório de Vibrações Mecânicas e Práticas Integrativas - Policlínica Universitária Piquet Carneiro
state: RJ
Study officials:
affiliation: Laboratório de Vibrações Mecânicas e Integrativas - LAVIMPI/UERJ
name: Ana Carolina Coelho-Oliveira
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coelho-Oliveira AC, Monteiro-Oliveira BB, Goncalves de Oliveira R, Reis-Silva A, Ferreira-Souza LF, Lacerda ACR, Mendonca VA, Sartorio A, Taiar R, Bernardo-Filho M, Sa-Caputo D. Evidence of Use of Whole-Body Vibration in Individuals with Metabolic Syndrome: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2023 Feb 20;20(4):3765. doi: 10.3390/ijerph20043765.