Systemic Vibratory Therapy and Osteopathic Manipulative Treatment in Individuals With Obesity

Official title

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

Overview

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).

Detailed description

For anamnesis, data is collected from participants, including age, sex, smoking status, alcohol consumption, presence and type of diabetes mellitus, presence of systemic arterial hypertension, associated comorbidities, medication use, history of COVID-19, and physical inactivity.

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.

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.

Primary outcome measures

• Heart rate variability [Time frame: Heart rate variability analyzed at the baseline (day 1), immediately after the intervention (day 1), and after 12 sessions of the intervention (day 12).]
• Heart rate [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Systemic arterial pressure [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Anthropometric measurements [Time frame: Analyzed at the baseline (day 1) and after 12 sessions of the intervention (day 12).]
• Body Mass Index (BMI) [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Waist-to-Hip Ratio (WHR) [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Waist-to-Height Ratio (WHtR) [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Conicity Index [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Basal Metabolic Rate [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Visceral Fat Area [Time frame: From enrollment to the end of treatment at 6 weeks.]

Secondary outcome measures (12)

• Funcional parameters [Time frame: Analyzed at the baseline (day 1) and after 12 sessions of the intervention (day 12).]
• Metabolic Biomarkers [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Hormonal Biomarkers [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Uric Acid Levels [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Lipid Profile and Fasting Blood Glucose [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Glycated Hemoglobin (HbA1c) [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Muscle strength [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Pain Level [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Physical activity [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Mental health [Time frame: From enrollment to the end of treatment at 6 weeks.]
• Anterior Trunk Flexion Test [Time frame: From enrollment to the end of treatment at 6 weeks.]
• The Borg scale [Time frame: From enrollment to the end of treatment at 6 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Laboratório de Vibrações Mecânicas e Práticas Integrativas - LAVIMPI — Rio de Janeiro

Identifiers

NCT: NCT06971159 · 30649620.1.0000.5259

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗