ObesitySVT and OMTNCT06971159
Systemic Vibratory Therapy and Osteopathic Manipulative Treatment in Individuals With Obesity
A study testing Systemic vibratory therapy and Osteopathic manipulative treatment in people with Obesity, run by Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Systemic vibratory therapy and Osteopathic manipulative treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Mar 2021to 30 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals of both sexes;
- Individuals with obesity;
- Over 18 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daniel B Batouli-Santos, Researcher contact
Brazil1 site, 1 recruiting
- Recruiting
Laboratório de Vibrações Mecânicas e Práticas Integrativas - LAVIMPI
Rio de Janeiro, Rio de Janeiro, 20950-003
Laboratorio de Vibrações Mecânicas e Práticas Integrativas, +552125667367, lavimpi.uerj@gmail.com
About this study
Official title: Clinical, Metabolic, Physical, Functional, Biochemical, and Cardiovascular Evaluation in Individuals With Obesity After Performing Systemic Vibratory Therapy and Osteopathic Manipulative Treatment
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.
Read more
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).
Read the 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.
- Conditions
- Obesity
- Being tested
- Systemic vibratory therapy, Osteopathic manipulative treatment, Sham
- Keywords
- systemic vibratory therapy, osteopathic manipulative treatment, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic vibratory therapyDevice
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 treatmentOther
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.
ShamOther
In the sham group, the interventions are simulated, as described in the sham group protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: 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). Receives: 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. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 6 weeks.
Secondary outcomes (12)
Funcional parameters
Timed Up and Go test - The volunteer sits on a chair, is ordered to stand up and walk to a mark on the floor (distance of 3 meters), turns and returns to the chair, sits on the chair, the time spent is measured in seconds and thousandths of a second with a stopwatch.
Measured: Analyzed at the baseline (day 1) and after 12 sessions of the intervention (day 12).
Metabolic Biomarkers
Peripheral blood samples were aseptically collected using an intravenous catheter inserted into an antecubital vein. The blood was separated by centrifugation. Serum cortisol levels were assessed in serum samples using standard laboratory techniques after an 8-hour fasting period. Unit of Measure: µg/dL. Sample collection was conducted at the Clinical Analysis Laboratory (Cápsula) of PPC-UERJ, always during the same shift, no later than 8:00 AM.
Measured: From enrollment to the end of treatment at 6 weeks.
Hormonal Biomarkers
Peripheral blood samples were aseptically collected using an intravenous catheter inserted into an antecubital vein. The blood was separated by centrifugation. Insulin, and growth hormone (HGH) levels were assessed in serum samples using standard laboratory techniques after an 8-hour fasting period. Unit of Measure: ng/mL. Sample collection was conducted at the Clinical Analysis Laboratory (Cápsula) of PPC-UERJ, always during the same shift, no later than 8:00 AM.
Measured: From enrollment to the end of treatment at 6 weeks.
Uric Acid Levels
Peripheral blood samples were aseptically collected using an intravenous catheter inserted into an antecubital vein. The blood was separated by centrifugation. Serum uric acid levels were measured in serum samples collected after an 8-hour fasting period. Unit of Measure: mg/dL. Sample collection was conducted at the Clinical Analysis Laboratory (Cápsula) of PPC-UERJ, always during the same shift, no later than 8:00 AM.
Measured: From enrollment to the end of treatment at 6 weeks.
Lipid Profile and Fasting Blood Glucose
Peripheral blood samples were aseptically collected using an intravenous catheter inserted into an antecubital vein. The blood was separated by centrifugation. Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride levels were measured in serum samples, and fasting blood glucose levels were measured in plasma samples. All measures collected after an 8-hour fasting period. Unit of Measure: mg/dL Sample collection was conducted at the Clinical Analysis Laboratory (Cápsula) of PPC-UERJ, always during the same shift, no later than 8:00 AM.
Measured: From enrollment to the end of treatment at 6 weeks.
Glycated Hemoglobin (HbA1c)
Peripheral blood samples were aseptically collected using an intravenous catheter inserted into an antecubital vein. The blood was separated by centrifugation. Glycated hemoglobin (HbA1c, %) levels were measured in plasma samples collected after an 8-hour fasting period. Unit of Measure: % (for HbA1c). Sample collection was conducted at the Clinical Analysis Laboratory (Cápsula) of PPC-UERJ, always during the same shift, no later than 8:00 AM.
Measured: From enrollment to the end of treatment at 6 weeks.
Muscle strength
The Lafayette dynamometer (hand grip dynamometers model j00105) will be used. Participants will be seated with their feet on the floor, their arm in adduction and elbow flexed at 90°, their forearm in a neutral position and their wrist extended between 0° and 30°. Three repetitions of maximum grip of 3 seconds will be performed, with a recovery period of 60 seconds between repetitions.
Measured: From enrollment to the end of treatment at 6 weeks.
Pain Level
It is essential to know the participant's pain, and to assess pain, scales such as the visual analogue scale (VAS) will be used, which consists of a ruler divided into eleven equal parts from zero to ten, where the individual is expected to make the equivalence according to the level of their pain through the numerical classification (zero corresponding to the least and ten to the greatest pain).
Measured: From enrollment to the end of treatment at 6 weeks.
Physical activity
Assessing the level of physical activity is essential to assess an individual's current health conditions and helps to determine which exercises can be part of their routine. This assessment allows the identification of physical and biological limitations, in addition to finding signs of some diseases. Thus, to classify the level of physical activity of the individual, duly validated questionnaires will be used, such as the International Physical Activity Questionnaire (IPAQ), which allows the estimation of the weekly time spent in moderate and vigorous physical activities in different contexts of daily life. The short version will be applied, consisting of 7 open questions, and its information allows the estimation of the time spent per week in different dimensions of physical activity (walking and physical efforts of moderate and vigorous intensity) and physical inactivity (sitting position).
Measured: From enrollment to the end of treatment at 6 weeks.
Mental health
The Mini Mental State Examination (MMSE) is a screening instrument to assess the domains (spatial and temporal orientation, immediate and recall memory, calculation, language-naming, repetition, comprehension, writing, and copying of drawings). The MMSE is a cognitive screening test that assesses cognitive function and may indicate dementia. The total score ranges from 0 to 30, with scores above 25 indicating normal cognitive function. Score Interpretation: 26-30 points: Normal cognitive function. 21-24 points: Mild cognitive impairment. 10-20 points: Moderate cognitive impairment. Less than or equal to 9 points: Severe cognitive impairment. Low or very low scores: Strong correlation with dementia, but other mental disorders may also affect the result.
Measured: From enrollment to the end of treatment at 6 weeks.
Anterior Trunk Flexion Test
The Anterior trunk flexion test measures the distance between the tip of the middle finger and the floor after the participant performs forward trunk flexion with feet together and knees straight. The result is recorded in centimeters (cm) and uses the distance between the third finger and the floor. Unit of Measure: Centimeters (cm).
Measured: From enrollment to the end of treatment at 6 weeks.
The Borg scale
The Borg scale is a numerical scale from "0" to "10", where the patient will indicate a score for their level of tiredness, at the beginning and end of each session, with "0" being no tiredness and "10" being maximum tiredness.
Measured: From enrollment to the end of treatment at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start5 Mar 2021
- Primary completion30 Dec 2029 (estimated)
- Study completion30 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971159
- Sponsor's protocol ID
- 30649620.1.0000.5259
- Acronym
- SVT and OMT
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD supporting the results in publications will be utilized.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Metabolic, Physical, Functional, Biochemical, and Cardiovascular Evaluation in Individuals With Obesity After Performing Systemic Vibratory Therapy and Osteopathic Manipulative Treatment
- ClinicalTrials.gov ID
- NCT06971159
- Acronym / sponsor ID
- SVT and OMT / 30649620.1.0000.5259
- Conditions
- Obesity
- Keywords
- systemic vibratory therapy, osteopathic manipulative treatment, obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Laboratorio de Vibraçoes Mecanicas e Praticas IntegrativasUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 May 2030 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Systemic Vibratory Therapy Group | Experimental | Device: Systemic vibratory therapyThe 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. |
| Osteopathic manipulative treatment group | Experimental | Other: Osteopathic manipulative treatmentOsteopathic 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. |
| Systemic vibratory therapy combined with osteopathic manipulative treatment | Experimental | Device: Systemic vibratory therapy, Other: Osteopathic manipulative treatmentIn 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). |
| Osteopathic manipulative treatment combined with systemic vibratory therapy | Experimental | Device: Systemic vibratory therapy, Other: Osteopathic manipulative treatmentIn 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 group | Sham comparator | Other: ShamIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals of both sexes;
- Individuals with obesity;
- Over 18 years old.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic vibratory therapySystemic 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. | Device | Osteopathic manipulative treatment combined with systemic vibratory therapy, Systemic Vibratory Therapy Group, Systemic vibratory therapy combined with osteopathic manipulative treatment |
| Osteopathic manipulative treatmentOsteopathic 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 | Osteopathic manipulative treatment combined with systemic vibratory therapy, Osteopathic manipulative treatment group, Systemic vibratory therapy combined with osteopathic manipulative treatment |
| ShamIn the sham group, the interventions are simulated, as described in the sham group protocol. | Other | Sham group |
Primary outcome
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 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
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
Systemic arterial pressure
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
Anthropometric measurements
Time frame: Analyzed at the baseline (day 1) and after 12 sessions of the intervention (day 12).
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.
Body Mass Index (BMI)
Time frame: From enrollment to the end of treatment at 6 weeks.
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).
Waist-to-Hip Ratio (WHR)
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
Waist-to-Height Ratio (WHtR)
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
Conicity Index
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
Basal Metabolic Rate
Time frame: From enrollment to the end of treatment at 6 weeks.
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).
Visceral Fat Area
Time frame: From enrollment to the end of treatment at 6 weeks.
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).
Body Fat Percentage
Time frame: From enrollment to the end of treatment at 6 weeks.
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 (%).
Lean Body Mass, Fat Mass, and Skeletal Muscle Mass
Time frame: From enrollment to the end of treatment at 6 weeks.
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).
Total Body Water
Time frame: From enrollment to the end of treatment at 6 weeks.
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).
Oxygen saturation
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
Respiratory rate
Time frame: From enrollment to the end of treatment at 6 weeks.
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.
12 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Yes. All collected IPD supporting the results in publications will be utilized.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel B Batouli-Santos, Researcher contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic vibratory therapy and Osteopathic manipulative treatment in people with Obesity, run by Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danúbia da Cunha de Sá Caputo, Dra. (+552125667367, dradanubia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.