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

NCT06907108 | Completed

• 2 other identifiers: 54981315.6.0000.5259RBR-2bghmh
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (15)

• Glycated Hemoglobin (HbA1c)

  Peripheral blood samples were aseptically collected using an intravenous catheter inserted into an antecubital vein. The blood was separated by centrifugation. Glycated hemoglobin (HbA1c, %) levels were measured in plasma samples collected after an 8-hour fasting period. Unit of Measure: % (for HbA1c). Sample collection was conducted at the Clinical Analysis Laboratory (Cápsula) of PPC-UERJ, always during the same shift, no later than 8:00 AM.

  From enrollment to the end of treatment at 6 weeks.

• Lipid Profile and Fasting Blood Glucose

  Peripheral blood samples were aseptically collected using an intravenous catheter inserted into an antecubital vein. The blood was separated by centrifugation. Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride levels were measured in serum samples, and fasting blood glucose levels were measured in plasma samples. All measures collected after an 8-hour fasting period. Unit of Measure: mg/dL Sample collection was conducted at the Clinical Analysis Laboratory (Cápsula) of PPC-UERJ, always during the same shift, no later than 8:00 AM.

  From enrollment to the end of treatment at 6 weeks.

• Uric Acid Levels

  Peripheral blood samples were aseptically collected using an intravenous catheter inserted into an antecubital vein. The blood was separated by centrifugation. Serum uric acid levels were measured in serum samples collected after an 8-hour fasting period. Unit of Measure: mg/dL. Sample collection was conducted at the Clinical Analysis Laboratory (Cápsula) of PPC-UERJ, always during the same shift, no later than 8:00 AM.

  From enrollment to the end of treatment at 6 weeks.

• Hormonal Biomarkers

  Peripheral blood samples were aseptically collected using an intravenous catheter inserted into an antecubital vein. The blood was separated by centrifugation. Insulin, and growth hormone (HGH) levels were assessed in serum samples using standard laboratory techniques after an 8-hour fasting period. Unit of Measure: ng/mL. Sample collection was conducted at the Clinical Analysis Laboratory (Cápsula) of PPC-UERJ, always during the same shift, no later than 8:00 AM.

  From enrollment to the end of treatment at 6 weeks.

• Metabolic Biomarkers

  Peripheral blood samples were aseptically collected using an intravenous catheter inserted into an antecubital vein. The blood was separated by centrifugation. Serum cortisol levels were assessed in serum samples using standard laboratory techniques after an 8-hour fasting period. Unit of Measure: µg/dL. Sample collection was conducted at the Clinical Analysis Laboratory (Cápsula) of PPC-UERJ, always during the same shift, no later than 8:00 AM.

  From enrollment to the end of treatment at 6 weeks.

• Total Body Water

  The measure of the Total Body Water 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 Measured: in liters (L).

  From enrollment to the end of treatment at 6 weeks.

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

  The measures of 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. The following body composition components will be measured: Lean Body Mass: Measured in kilograms (kg). Fat Mass: Measured in kilograms (kg). Skeletal Muscle Mass: Measured in kilograms (kg).

  From enrollment to the end of treatment at 6 weeks.

• 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 (%).

  From enrollment to the end of treatment at 6 weeks.

• Visceral Fat Area

  The visceral fat area 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: square centimeters (cm²).

  From enrollment to the end of treatment at 6 weeks.

• 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).

  From enrollment to the end of treatment at 6 weeks.

• 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).

  From enrollment to the end of treatment at 6 weeks.

• 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.

  From enrollment to the end of treatment at 6 weeks.

• 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.

  From enrollment to the end of treatment at 6 weeks.

• Conicity Index

  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.

  From enrollment to the end of treatment at 6 weeks.

• 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 ankle.

  From enrollment to the end of treatment at 6 weeks.

Secondary Outcomes (12)

• Functionality

  From enrollment to the end of treatment at 6 weeks.

• Lumbar spine flexibility

  From enrollment to the end of treatment at 6 weeks.

• Anterior Trunk Flexion Test

  From enrollment to the end of treatment at 6 weeks.

• Health-related quality of life

  From enrollment to the end of treatment at 6 weeks.

• Pittsburgh Sleep Quality Index (PSQI)

  From enrollment to the end of treatment at 6 weeks.

Study Arms (2)

Fixed Frequency (FF)

ACTIVE COMPARATOR

In the FF group, a frequency of 5Hz, peak-to-peak displacements of 2.5, 5.0, and 7.5 mm, with 1 min of working time with 10s "on" and 50s "off" and 1 min of rest, were used. During the protocol, the individuals performed static and dynamic squats (intercalated days). One minute of vibration and one minute without vibration were performed in each peak-to-peak displacement, which corresponds to one sequence (one series). From the 1st to the 4th session, 3 sequences were performed (totaling 18 minutes); from the 5th to the 8th session, 4 sequences were performed (totaling 24 minutes); and from the 9th to the 12th session, 5 sequences were performed (totaling 30 minutes).

Device: Systemic vibratory therapy

Varied Frequency (VF)

ACTIVE COMPARATOR

In the VF group, frequencies ranged from 5 to16 Hz (increasing 1 Hz with each session), the work time was 1 min and 1 min rest, and the peak-to-peak displacements of 2.5, 5.0, and 7.5 mm. During the protocol, the individuals performed static and dynamic squats (intercalated days). One minute of vibration and one minute without vibration were performed in each peak-to-peak displacement, which corresponds to one sequence (one series). From the 1st to the 4th session, 3 sequences were performed (totaling 18 minutes); from the 5th to the 8th session, 4 sequences were performed (totaling 24 minutes); and from the 9th to the 12th session, 5 sequences were performed (totaling 30 minutes).

Device: Systemic vibratory therapy

Interventions

Systemic vibratory therapy DEVICE

The interventions were performed on a vibratory platform with side-alternating displacement of the base (Novaplate Fitness Evolution model, DAF Produtos Hospitalares Ltda, São Paulo). The individual was positioned barefoot, with knees flexed at 130º on the base of the vibratory platform. The protocol was performed over a 6-week period with 2 weekly sessions, totaling 12 sessions. The frequency was 5-16Hz according the protocol, and the peak-to-peak displacement was 2.5, 5.0, and 7.5 mm in all sessions. During the protocol, the individuals performed static and dynamic squats, with one static and one dynamic session (interleaved). The variables were evaluated before and after the interventions.

Fixed Frequency (FF); Varied Frequency (VF)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Rio de Janeiro State University: collaborator

Study Sites (1)

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

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

Location

Related Publications (1)

• 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.

  PMID: 36834459 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ana Carolina Coelho-Oliveira

  Laboratório de Vibrações Mecânicas e Integrativas - LAVIMPI/UERJ

  PRINCIPAL INVESTIGATOR

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: March 7, 2025
• First Posted: April 2, 2025
• Study Start: November 1, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Available indefinitely
• Access Criteria: Unending

Locations

BR (1)