Systemic Vibratory Therapy and Osteopathic Manipulative Treatment in Individuals With Obesity
NCT ID: NCT06971159
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
90 participants
INTERVENTIONAL
2021-03-05
2030-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Manual Therapy Techniques for Cervical Pain: Algometric Evaluation
NCT06982456
Normalizing Cervical Intersegmental Kinematics With Spinal Manipulative Therapy
NCT06312696
A Study of the Effects of Mid-Thoracic Spinal Manipulation and Spinal Mobilization on Heart Rate Variability
NCT02380599
Osteopathic Treatment for Chronic Low Back Pain
NCT02983435
Electroencephalography Activity in Individuals With Nonspecific Chronic Low Back Pain After Cranial Osteopathic Manipulative Treatment
NCT02111382
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
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).
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.
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.
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).
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.
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.
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.
Sham
In the sham group, the interventions are simulated, as described in the sham group protocol.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Sham
In the sham group, the interventions are simulated, as described in the sham group protocol.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Individuals with obesity;
* Over 18 years old.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Universidade do Estado do Rio de Janeiro - UERJ
UNKNOWN
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Laboratório de Vibrações Mecânicas e Práticas Integrativas - LAVIMPI
Rio de Janeiro, Rio de Janeiro, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Daniel B Batouli-Santos, Researcher
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Laboratorio de Vibrações Mecânicas e Práticas Integrativas
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
30649620.1.0000.5259
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.