Clinical trial NCT06971159: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: systemic vibratory therapy
osteopathic manipulative treatment
obesity
Lead sponsor: Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Universidade do Estado do Rio de Janeiro - UERJ
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2025-05-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

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.

Primary outcomes:
measure: Heart rate variability
timeFrame: Heart rate variability analyzed at the baseline (day 1), immediately after the intervention (day 1), and after 12 sessions of the intervention (day 12).
measure: Heart rate
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Systemic arterial pressure
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Anthropometric measurements
timeFrame: Analyzed at the baseline (day 1) and after 12 sessions of the intervention (day 12).
measure: Body Mass Index (BMI)
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Waist-to-Hip Ratio (WHR)
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Waist-to-Height Ratio (WHtR)
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Conicity Index
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Basal Metabolic Rate
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Visceral Fat Area
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Body Fat Percentage
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Lean Body Mass, Fat Mass, and Skeletal Muscle Mass
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Total Body Water
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Oxygen saturation
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Respiratory rate
timeFrame: From enrollment to the end of treatment at 6 weeks.
Secondary outcomes:
measure: Funcional parameters
timeFrame: Analyzed at the baseline (day 1) and after 12 sessions of the intervention (day 12).
measure: Metabolic Biomarkers
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Hormonal Biomarkers
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Uric Acid Levels
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Lipid Profile and Fasting Blood Glucose
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Glycated Hemoglobin (HbA1c)
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Muscle strength
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Pain Level
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Physical activity
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Mental health
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: Anterior Trunk Flexion Test
timeFrame: From enrollment to the end of treatment at 6 weeks.
measure: The Borg scale
timeFrame: From enrollment to the end of treatment at 6 weeks.
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Laboratório de Vibrações Mecânicas e Práticas Integrativas - LAVIMPI
state: RJ
Study officials:
References: