Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 4:05 PM
Study NCT ID:
NCT06971159
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Vibratory Therapy and Osteopathic Manipulative Treatment in Individuals With Obesity
Sponsor:
Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas
Organization:
Study Overview
Official Title:
Clinical, Metabolic, Physical, Functional, Biochemical, and Cardiovascular Evaluation in Individuals With Obesity After Performing Systemic Vibratory Therapy and Osteopathic Manipulative Treatment
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SVT and OMT
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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: