Systemic Vibratory Therapy and Osteopathic Manipulative Treatment in Individuals With Obesity (SVT and OMT)

Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas

Status: Enrolling

Conditions: Obesity

Treatments: Other: Sham; Other: Osteopathic manipulative treatment; Device: Systemic vibratory therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06971159

30649620.1.0000.5259

Details and patient eligibility

About

Studies have demonstrated a strong relationship between physical inactivity and the presence of obesity and other cardiovascular risk factors such as hypertension, insulin resistance, diabetes, dyslipidemia, and metabolic syndrome. On the other hand, regular physical exercise has been recommended for the prevention and treatment of cardiovascular diseases, their risk factors, and other chronic conditions.

Systemic vibratory therapy (SVT) and osteopathic manipulative treatment (OMT) has been proposed as alternative therapies for this population.

The aim of this project is to assess clinical, metabolic, physical, functional and cardiovascular parameters, in individuals with obesity undergoing systemic vibratory therapy and the osteopathic manipulative treatment.

The clinical evaluation included measurements of heart rate variability, systemic blood pressure, heart rate, respiratory rate, oxygen saturation, handgrip dynamometry, the BORG scale, NPS (Numerical Pain Scale), and RPE (Rating of Perceived Exertion) scale; anthropometric measurements including neck, abdominal, hip, arm, thigh and calf circumferences; as well as body composition assessment and anterior trunk flexibility. Additional information was collected, including age, sex, smoking status, physical inactivity, associated comorbidities and medication use.

Laboratory analyses included a complete blood count, total cholesterol and its fractions, triglycerides, creatinine, uric acid, cortisol, glucose, insulin, growth hormone, vitamin D, and other relevant blood parameters. Questionnaires were administered to access the level of physical activity.

Participants were randomized into five groups: systemic vibratory therapy group (SVT), osteopathic manipulative treatment group (OMT), SVT+OMT, OMT+SVT, and control group. The parameters mentioned above are collected before the intervention (baseline), immediately after one session of the respective intervention (acute effect), and after 12 sessions (cumulative effect).

Full description

For anamnesis, data is collected from participants, 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 are conducted before and after the 12 sessions of systemic vibratory therapy, including measurements of systemic blood pressure, heart rate variability, heart rate, oxygen saturation, respiratory rate, the BORG scale and the Numeric Pain Scale (NPS). Anthropometric measurements were collected, including neck, arm, abdominal, hip, thigh and ankle circumferences, as well as body composition distribution assessed via bioelectrical impedance, and lumbar spine flexibility via anterior trunk flexion test.

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

Neuromuscular activity is assessed using handgrip strength via a manual dynamometer.

Heart rate variability is assessed using a heart rate monitor.

Patients were positioned on the platform base under the supervision of a healthcare professional to perform the interventions.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals of both sexes;
• Individuals with obesity;
• Over 18 years old.

Exclusion criteria

• Body mass index (BMI) < 30 kg/m2;
• Uncontrolled untreated hypertension, with elevated systemic blood pressure levels (≥180 x 110 mmHg);
• Cardiovascular diseases (myocardial infarction/stroke), in the last 6 months;
• Atrial fibrillation;
• History of spine surgery;
• Neurological, rheumatological diseases or osteoarticular lesions that hinder movements of the vibrating platform (VP);
• Serious or disabling diseases, at the discretion of the investigator;
• Individuals who refuse to sign the Informed Consent Form (ICF) to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 5 patient groups

Systemic Vibratory Therapy Group

Experimental group

Description:

The SVT interventions occur on the alternating vibrating platform (VP) (Novaplate fitness evolution, DAF Produtos Hospitalares Ltda, São Paulo). The individual is positioned barefoot, with 130º of knee flexion, frequency of 30 Hz, peak-to-peak displacement of 2.5 mm. The individuals will perform 9 sets of SVT consisting of 1 minute of vibration with 1 minute of rest, totaling 17 minutes of exercise.

Treatment:

Device: Systemic vibratory therapy

Osteopathic manipulative treatment group

Experimental group

Description:

Osteopathic manipulative treatment consists of the following techniques: i) suboccipital inhibition technique (5 minutes) and suboccipital decompression (3 minutes); ii) myofascial release technique of the cervical spinal muscles (2 minutes); iii) diaphragm muscle release technique (5 minutes), totaling 15 minutes of treatment.

Treatment:

Other: Osteopathic manipulative treatment

Systemic vibratory therapy combined with osteopathic manipulative treatment

Experimental group

Description:

In this group, individuals undergo a combined treatment. First, systemic vibration therapy is performed (according to the protocol mentioned in the systemic vibration therapy group) and then osteopathic manipulative treatment is performed (according to the protocol mentioned in the osteopathic manipulative treatment group).

Treatment:

Device: Systemic vibratory therapy

Other: Osteopathic manipulative treatment

Osteopathic manipulative treatment combined with systemic vibratory therapy

Experimental group

Description:

In this group, individuals undergo a combined treatment. First, osteopathic manipulative treatment is performed (according to the protocol mentioned in the osteopathic manipulative treatment group) and then systemic vibration therapy is performed (according to the protocol mentioned in the systemic vibration therapy group).

Treatment:

Device: Systemic vibratory therapy

Other: Osteopathic manipulative treatment

Sham group

Sham Comparator group

Description:

In the sham group, simulation of the SVT is performed, where the individual is stand on the PV, barefoot, with 130º of knee flexion and remain in this position during the active periods of the protocol, with the PV turned off, emitting only a vibration simulation through a device attached to it and the OMT in which the researcher will perform a treatment simulation by simply placing his hands on the suboccipital, cervical and diaphragm muscle regions, without exercising any therapeutic intention.

Treatment:

Other: Sham