Systemic Vibratory Therapy and Osteopathic Manipulative Treatment in Individuals With Obesity
Recruiting · NCT06971159 · Interventional (participants receive a specific treatment) · Lead sponsor: Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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).
Who can take part
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.
Where it is running
1 location listed.
- Laboratório de Vibrações Mecânicas e Práticas Integrativas - LAVIMPI - Rio de Janeiro, Rio de Janeiro, Brazil