Systemic Vibratory Therapy and Osteopathic Manipulative Treatment in Individuals With Obesity

NCT06971159 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-14

No results posted yet for this study

Summary

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).

Conditions

Interventions

DEVICE

Systemic vibratory therapy

Systemic vibratory therapy is an intervention in which mechanical vibration, generated by the vibrating platform, is transmitted to the whole-body of the individual generating whole-body vibration exercise.

OTHER

Osteopathic manipulative treatment

Osteopathic manipulative treatment is defined by the WHO as a diagnostic and therapeutic method that uses manual contact for these purposes. It concerns the relationship between body, mind and spirit in health and illness, emphasizing the structural and functional integrity of the body and the body's intrinsic tendency to direct itself towards healing.

OTHER

Sham

In the sham group, the interventions are simulated, as described in the sham group protocol.

Sponsors & Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV
  • Universidade do Estado do Rio de Janeiro - UERJ

    collaborator UNKNOWN
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

    collaborator OTHER_GOV
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV
  • Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2029-12-30
Completion
2030-05-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06971159 on ClinicalTrials.gov