Clinical, Metabolic, Physical, Functional, Biochemical, and Cardiovascular Evaluation in Individuals With Obesity After Performing Systemic Vibratory Therapy and Osteopathic Manipulative Treatment

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Individuals of both sexes;

• Individuals with obesity;

• Over 18 years old.

Locations
Other Locations
Brazil
Laboratório de Vibrações Mecânicas e Práticas Integrativas - LAVIMPI
RECRUITING
Rio De Janeiro
Contact Information
Primary
Danúbia da Cunha de Sá Caputo, Dra.
dradanubia@gmail.com
+552125667367
Backup
Daniel B Batouli-Santos, Researcher
+5521988460007
Time Frame
Start Date: 2021-03-05
Estimated Completion Date: 2030-05-30
Participants
Target number of participants: 90
Treatments
Experimental: Systemic Vibratory Therapy Group
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.
Experimental: Osteopathic manipulative treatment group
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.
Experimental: Systemic vibratory therapy combined with osteopathic manipulative treatment
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).
Experimental: Osteopathic manipulative treatment combined with systemic vibratory therapy
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).
Sham_comparator: Sham group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Universidade do Estado do Rio de Janeiro - UERJ, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Leads: Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas

This content was sourced from clinicaltrials.gov