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

Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas

Status: Completed

Conditions: Metabolic Syndrome X; Metabolic Syndrome Obesity; Metabolic Syndrome

Treatments: Device: Systemic vibratory therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06907108

RBR-2bghmh (Registry Identifier)

54981315.6.0000.5259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Fixed Frequency (FF)

Active Comparator group

Description:

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).

Treatment:

Device: Systemic vibratory therapy

Varied Frequency (VF)

Active Comparator group

Description:

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).

Treatment:

Device: Systemic vibratory therapy