NCT06971159Recruiting
Systemic Vibratory Therapy and Osteopathic Manipulative Treatment in Individuals With Obesity
Clinical, Metabolic, Physical, Functional, Biochemical, and Cardiovascular Evaluation in Individuals With Obesity After Performing Systemic Vibratory Therapy and Osteopathic Manipulative Treatment
Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 28 Apr 2025
- Start date
- 5 Mar 2021
- Primary completion date
- 30 Dec 2029
- Lead sponsor
- Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas
- Diseases
- Obesity
- NCT number
- NCT06971159
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 5 Mar 2021 to the primary completion date, 30 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled untreated hypertension, with elevated systemic blood pressure levels (≥180 x 110 mmHg);
- Cardiovascular diseases (myocardial infarction/stroke), in the last 6 months;
- 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;
Other
- Body mass index (BMI) \< 30 kg/m2;
- Atrial fibrillation;
- Individuals who refuse to sign the Informed Consent Form (ICF) to participate in the study.
Who the study is looking for
- Individuals of both sexes;
- Individuals with obesity;
- Over 18 years old.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Laboratório de Vibrações Mecânicas e Práticas Integrativas - LAVIMPI Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.