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临床试验/NCT07729215
NCT07729215已完成不适用

Evaluation of the Effects of Systemic Vibration Therapy on Thermogenesis, Cardiovascular Parameters, Endocrine-inflammatory Markers, and Physical-functional Performance in Adults With Obesity.

Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Thermogenin

研究概览

简要总结

The goal of this clinical trial was to evaluate the effects of Systemic Vibration Therapy (SVT) on thermogenesis, cardiovascular health, endocrine-inflammatory markers, and physical performance in adults (men and women, aged 18-59) with obesity. The main questions it aimed to answer were:

What were the effects of SVT on thermogenesis and physical-functional performance in people with obesity?

How did SVT affect cardiovascular risk, hormone levels, and inflammation?

Researchers compared two types of vibrating platforms (vertical and side-alternating) to a placebo group (where the platform was turned off but simulated the sound) to see if the vibration led to changes in these health parameters.

Participants:

Attended sessions 2 times per week for either 6 or 12 weeks.

Stood barefoot in a static squat position on a vibrating platform for 29 minutes per session (alternating 1 minute of vibration with 1 minute of rest).

Underwent health assessments, including blood tests, body composition scans, muscle strength tests, and quality of life questionnaires.

详细描述

Obesity is characterized by the excessive accumulation of body fat and triggers systemic impacts. Currently, it affects 1 in 8 people worldwide, with projections of generating global costs of US$ 3 trillion per year by 2030. In Brazil, prevalence may reach 30.4%. Central obesity is associated with chronic inflammation, insulin resistance, metabolic dysfunctions, and an increased risk of cardiovascular diseases (CVD), which are the leading causes of death globally. Low-grade inflammation and alterations in the autonomic nervous system also exacerbate cardiovascular risk. In this context, brown adipose tissue, with its thermogenic function, has been studied as a potential ally in body mass control. Excess fat combined with muscle mass loss accentuates functional impairments. Although physical exercise is essential, low adherence among individuals with obesity requires viable alternatives. Systemic vibration therapy (SVT), which utilizes mechanical vibrations through vibrating platforms, emerges as a promising strategy, with evidence of effects on reducing body fat, increasing muscle strength, and modulating hormonal and neuromuscular responses. However, conclusive evidence regarding the best protocols is lacking, justifying further studies.This study aims to evaluate the effects of SVT on thermogenesis, cardiovascular, endocrine-inflammatory parameters, and the physical-functional performance of adults with obesity by applying different protocols. Individuals aged 18 to 59 of both sexes, with a BMI ≥ 30 kg/m² and WHR ≥ 0.50, will be included. Recruitment will take place at HUPE, PPC/UERJ, the general community, and social media. The sample size calculation indicated a need for 30 participants, accounting for potential dropouts. Personal information will be collected, and biochemical, endocrine-inflammatory, vascular, cardiovascular risk, body composition, muscle strength, electromyography, physical-functional tests, eating behavior, quality of life, cognition, sleep, vital signs, and perceived exertion assessments will be performed.Interventions will occur twice a week, with a 72-hour interval, for 6 and 12 weeks. Two types of vibrating platforms will be used: vertical displacement (VVP) and side-alternating displacement (AVP). Three protocols will be applied: the GAVP will use the AVP with a frequency of 30 Hz and an amplitude of 2.5 mm or 5.0 mm; the GVVP will use the VVP, also at 30 Hz with "low" amplitude; and the SG (Sham Group) will perform the same movements with the platform turned off, simulating the vibration sound. In all groups, participants will be barefoot, in a static squat with knees at $50^\circ$, for 1 minute of exposure followed by 1 minute of rest, repeated 15 times, totaling 29 minutes per session.

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 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals aged 18 to 59 years;
  • Both sexes;
  • Diagnosis of obesity, defined as a body mass index (BMI) ≥ 30 kg/m²;
  • Waist-to-height ratio (≥ 0.50).

排除标准

  • Presence of metallic prostheses;
  • Presence of a pacemaker;
  • Uncontrolled and untreated hypertension (≥180/120 mmHg);
  • History of labyrinthitis;
  • Previous diagnosis of deep vein thrombosis;
  • Pregnancy;
  • Recent surgery (within the previous 6 months);
  • Neurodegenerative, pulmonary, or infectious diseases;
  • Inability to undergo the proposed assessments and/or interventions.

结局指标

主要结局

Thermogenin

时间窗: Baseline, Week 6, and Week 12

Thermogenin (Uncoupling Protein 1 \[UCP1\]) was measured before and immediately after the WBV session. Blood samples were collected by a trained professional at the PPC/UERJ Clinical Analysis Laboratory (Capsule Unit), always during the same morning shift and no later than 8:00 a.m. For peripheral blood assays, serum and plasma collection tubes were centrifuged at 2,000 rpm at 25°C. Subsequently, 500 µL of serum was aliquoted into two microtubes and stored at -80°C until analysis. Serum UCP1 concentrations were determined using a specific enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions. Optical density (OD) was measured using a Thermo Scientific spectrophotometer.

Endocrine-inflammatory profile

时间窗: Baseline, Week 6, and Week 12

The endocrine-inflammatory profile was assessed by measuring Interleukin-1 beta (IL-1β), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin-6 (IL-6), Interleukin-8 (IL-8), Interleukin-10 (IL-10), Tumor Necrosis Factor-alpha (TNF-α), Soluble TNF Receptor Type I (sTNF-RI), Soluble TNF Receptor Type II (sTNF-RII), adiponectin, resistin, leptin, and irisin. Blood samples were collected by a trained professional at the PPC/UERJ Clinical Analysis Laboratory (Capsule Unit), always during the same morning shift and no later than 8:00 a.m. For peripheral blood assays, serum and plasma collection tubes were centrifuged at 2,000 rpm at 25°C. Subsequently, 500 µL of serum was aliquoted into two microtubes and stored at -80°C until analysis. Biomarker concentrations were determined using specific enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions. Optical density (OD) was measured using a Thermo Scientific spectrophotometer.

次要结局

  • Total Body Water(Baseline, Week 6, and Week 12)
  • Lean Body Mass, Fat Mass, and Skeletal Muscle Mass(Baseline, Week 6, and Week 12.)
  • Body Fat Percentage(Baseline, Week 6, and Week 12)
  • Basal Metabolic Rate(Baseline, Week 6, and Week 12)
  • Body Mass Index (BMI)(Baseline, Week 6, and Week 12)
  • Waist-to-Hip Ratio (WHR)(Baseline, Week 6, and Week 12)
  • Waist-to-Height Ratio (WHtR)(Baseline, Week 6, and Week 12)
  • Conicity Index (CI)(Baseline, Week 6, and Week 12)
  • Anthropometric measures(Baseline, Week 6, and Week 12)
  • Functionality(Baseline, Week 6, and Week 12)
  • Body Shape Index (ABSI)(Baseline, week 6, and week 12)
  • Health-related quality of life(Baseline, week 6, and week 12)
  • Muscle strength(Baseline, week , and week 12)

研究者

发起方
Laboratorio de Vibraçoes Mecanicas e Praticas Integrativas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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