Systemic Vibratory Therapy and Osteopathic Manipulative Treatment in Individuals With Obesity

NCT06971159 | Recruiting

• 1 other identifier: 30649620.1.0000.5259
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Keywords

systemic vibratory therapy; osteopathic manipulative treatment; obesity

Outcome Measures

Primary Outcomes (15)

• Heart rate variability

  Heart rate variability indices analyzed using a heart rate monitor. Indices are analyzed in the time domain (mean RR, SDNN, mean HR, RMSSD, pNN50), frequency domain (LF, HF, LF/HF ratio), and non-linear methods (SD1, SD2, SD2/SD1 ratio).

  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

  Heart rate (unit of measurement in beats per minute) is measured using the G-tech Led Digital Finger Oximeter. Resting, training, and recovery heart rates: These will be investigated to assess the intensity of physical effort in terms of the percentage of training achieved.

  From enrollment to the end of treatment at 6 weeks.

• Systemic arterial pressure

  Systemic arterial pressure (unit of measurement in mmHg) is measured with the individual seated, after 5 minutes of rest, with an automatic blood pressure monitor by OMRON, model HEM7113 (Japan), positioned on the individual's left arm, which should be relaxed and at heart level. The cuff will be positioned 3 to 4 cm above the antecubital fossa, with the elbow slightly flexed and the forearm in supination. This measurement will occur 3 times, with a 1-minute interval between them. The average of the three measurements will be considered for analysis.

  From enrollment to the end of treatment at 6 weeks.

• Anthropometric measurements

  Anthropometric measurements, as circumferences were assessed to evaluate the distribution of fat and other physical characteristics. The circumference measurements will be taken at the following sites, measured in centimeters (cm): neck, abdominal, hip, arm, thigh and calf circumferences.

  Analyzed at the baseline (day 1) and after 12 sessions of the intervention (day 12).

• Body Mass Index (BMI)

  Body Mass Index (BMI) is a clinical index that is used in bioimpedance to assess a person's weight. BMI is calculated by dividing the weight (in kg) by the height (in meters) squared. Unit of measure: kilograms per square meter (kg/m²).

  From enrollment to the end of treatment at 6 weeks.

• Waist-to-Hip Ratio (WHR)

  The ratio of the circumference of the waist to the circumference of the hips, used as an indicator of cardiovascular risk. WHR was calculated by dividing the waist circumference in centimeters by the hip circumference. It is an element for the prognosis of cardiovascular events in adults. The cut-off index for cardiovascular risk is less than 0.85 for women and 0.90 for men. The unit of measurement is unitless.

  From enrollment to the end of treatment at 6 weeks.

• Waist-to-Height Ratio (WHtR)

  The ratio of the circumference of the waist to height, used as an indicator of metabolic and cardiovascular risk. Height was measured using a vertical stadiometer graduated in centimeters and millimeters. Waist circumference was assessed using a tape measure graduated in centimeters and millimeters. The tape measure was placed midway between the iliac crest and the last rib. This anatomical point has the strongest correlation with abdominal adiposity. The values obtained were stratified into three categories: between 0.40 and 0.44 (lowest % fat, below the risk threshold); between 0.45 and 0.50 (moderate risk); between 0.50 and 0.56 (above the risk threshold). The unit of measurement is unitless.

  From enrollment to the end of treatment at 6 weeks.

• Conicity Index

  Conicity index is a measure of body fat distribution, particularly visceral fat, calculated using body circumference measurements. The C Index (CI) was determined based on the measurement of body mass, height and waist circumference, in meters, representing an indicator of abdominal obesity, and is based on the principle that some people accumulate fat around the abdomen, with the consequent change in body shape. This index is calculated using the formula: C Index = waist circumference (m)/(0.109 x (√ body mass (kg)/height (m))). For the classification of cardiovascular risk, values ≥ 1.18 for women and ≥ 1.25 for men are determined. The unit of measurement is unitless.

  From enrollment to the end of treatment at 6 weeks.

• Basal Metabolic Rate

  Basal Metabolic Rate will be analyzed using a Tetrapolar Bioelectrical Impedance Analyzer (InBody 370, BIOSPACE, Republic of Korea). The analyzer performs impedance measurements across five body segments (right arm, left arm, trunk, right leg, and left leg) using three different frequencies (5, 50, and 500 kHz), and provides separate body mass readings for each segment. The device provides separate body mass readings for different body segments, being able to estimate the basal metabolic rate. The basal metabolic rate is directly proportional to the weight and amount of muscle. It was calculated from predictive formulas using the results of the body composition, and involves the data of age, sex and physical activity that is entered into the scale. Unit of measure: kilocalories per day (kcal/day).

  From enrollment to the end of treatment at 6 weeks.

• Visceral Fat Area

  The visceral fat area of the body composition will be analyzed using a Tetrapolar Bioelectrical Impedance Analyzer (InBody 370, BIOSPACE, Republic of Korea). The analyzer performs impedance measurements across five body segments (right arm, left arm, trunk, right leg, and left leg) using three different frequencies (5, 50, and 500 kHz), and provides separate body mass readings for each segment. Unit of measure: square centimeters (cm²).

  From enrollment to the end of treatment at 6 weeks.

• Body Fat Percentage

  The Body fat percentage of the body composition will be analyzed using a Tetrapolar Bioelectrical Impedance Analyzer (InBody 370, BIOSPACE, Republic of Korea). The analyzer performs impedance measurements across five body segments (right arm, left arm, trunk, right leg, and left leg) using three different frequencies (5, 50, and 500 kHz), and provides separate body mass readings for each segment. Unit of measure: Expressed as a percentage (%).

  From enrollment to the end of treatment at 6 weeks.

• Lean Body Mass, Fat Mass, and Skeletal Muscle Mass

  The measures of body composition will be analyzed using a Tetrapolar Bioelectrical Impedance Analyzer (InBody 370, BIOSPACE, Republic of Korea). The analyzer performs impedance measurements across five body segments (right arm, left arm, trunk, right leg, and left leg) using three different frequencies (5, 50, and 500 kHz), and provides separate body mass readings for each segment. The following body composition components will be measured: Lean Body Mass: Measured in kilograms (kg). Fat Mass: Measured in kilograms (kg). Skeletal Muscle Mass: Measured in kilograms (kg).

  From enrollment to the end of treatment at 6 weeks.

• Total Body Water

  The measure of the Total Body Water of the body composition will be analyzed using a Tetrapolar Bioelectrical Impedance Analyzer (InBody 370, BIOSPACE, Republic of Korea). The analyzer performs impedance measurements across five body segments (right arm, left arm, trunk, right leg, and left leg) using three different frequencies (5, 50, and 500 kHz), and provides separate body mass readings for each segment. Unit of Measured: in liters (L).

  From enrollment to the end of treatment at 6 weeks.

• Oxygen saturation

  Oxygen saturation (unit of measurement in percentage) is measured using the G-tech Led Digital Finger Oximeter, with the individual seated, after 5 minutes of rest. This measurement will occur 3 times, with a 1-minute interval between them. The average of the three measurements will be considered for analysis.

  From enrollment to the end of treatment at 6 weeks.

• Respiratory rate

  Respiratory rate (unit of measurement in cycles per minute) is measured by observing how many respiratory cycles are performed per minute, with the individual in a lying, sitting and standing position.

  From enrollment to the end of treatment at 6 weeks.

Secondary Outcomes (12)

• Funcional parameters

  Analyzed at the baseline (day 1) and after 12 sessions of the intervention (day 12).

• Metabolic Biomarkers

  From enrollment to the end of treatment at 6 weeks.

• Hormonal Biomarkers

  From enrollment to the end of treatment at 6 weeks.

• Uric Acid Levels

  From enrollment to the end of treatment at 6 weeks.

• Lipid Profile and Fasting Blood Glucose

  From enrollment to the end of treatment at 6 weeks.

Study Arms (5)

Systemic Vibratory Therapy Group

EXPERIMENTAL

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.

Device: Systemic vibratory therapy

Osteopathic manipulative treatment group

EXPERIMENTAL

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.

Other: Osteopathic manipulative treatment

Systemic vibratory therapy combined with osteopathic manipulative treatment

EXPERIMENTAL

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).

Device: Systemic vibratory therapy; Other: Osteopathic manipulative treatment

Osteopathic manipulative treatment combined with systemic vibratory therapy

EXPERIMENTAL

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).

Device: Systemic vibratory therapy; Other: Osteopathic manipulative treatment

Sham group

SHAM COMPARATOR

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.

Other: Sham

Interventions

Systemic vibratory therapy DEVICE

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 combined with systemic vibratory therapy; Systemic Vibratory Therapy Group; Systemic vibratory therapy combined with osteopathic manipulative treatment

Osteopathic manipulative treatment OTHER

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; Osteopathic manipulative treatment group; Systemic vibratory therapy combined with osteopathic manipulative treatment

Sham OTHER

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

Sham group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals of both sexes;
• Individuals with obesity;
• Over 18 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Universidade do Estado do Rio de Janeiro - UERJ: collaborator
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Laboratório de Vibrações Mecânicas e Práticas Integrativas - LAVIMPI

Rio de Janeiro, Rio de Janeiro, 20950-003, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Manipulation, Osteopathic; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Danúbia da Cunha de Sá Caputo, Dra.

CONTACT

+552125667367; dradanubia@gmail.com

Daniel B Batouli-Santos, Researcher

CONTACT

+5521988460007

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 14, 2025
• Study Start: March 5, 2021
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): May 30, 2030
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Available indefinitely.
• Access Criteria: Unending.

Locations

BR (1)