Clinical, Metabolic, Physical, Functional, Biochemical, and Cardiovascular Evaluation in Individuals With Obesity After Performing Systemic Vibratory Therapy and Osteopathic Manipulative Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Heart rate variability
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sexes;
- •Individuals with obesity;
- •Over 18 years old.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Systemic vibratory therapy (Device)
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.
干预措施: Osteopathic manipulative treatment (Other)
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).
干预措施: Systemic vibratory therapy (Device)
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).
干预措施: Osteopathic manipulative treatment (Other)
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).
干预措施: Systemic vibratory therapy (Device)
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).
干预措施: Osteopathic manipulative treatment (Other)
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.
干预措施: Sham (Other)
结局指标
主要结局
Heart rate variability
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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).
Lean Body Mass, Fat Mass, and Skeletal Muscle Mass
时间窗: 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).
Visceral Fat Area
时间窗: 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
时间窗: 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 (%).
Total Body Water
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Glycated Hemoglobin (HbA1c)(From enrollment to the end of treatment at 6 weeks.)
- Muscle strength(From enrollment to the end of treatment at 6 weeks.)
- Pain Level(From enrollment to the end of treatment at 6 weeks.)
- Physical activity(From enrollment to the end of treatment at 6 weeks.)
- Mental health(From enrollment to the end of treatment at 6 weeks.)
- Anterior Trunk Flexion Test(From enrollment to the end of treatment at 6 weeks.)
- The Borg scale(From enrollment to the end of treatment at 6 weeks.)