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临床试验/NCT02546778
NCT02546778已完成不适用

Effects of Radiofrequency on Located Adiposity: A Pilot Study

Federal University of Health Science of Porto Alegre0 个研究点目标入组 30 人开始时间: 2014年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
Use of radio frequency reduce the layer of fat in abdominal area

研究概览

简要总结

Nowadays increasingly quest for improved physical appearance, gradually developing the medicine of beauty, where the radio fits as an additional tool in helping some aging processes and maintenance of body shape. The aim of this study was to evaluate and compare the changes in the thickness of adipose tissue and blood levels of some biochemical markers of sedentary and active women who underwent radio frequency technique via ultrasound imaging and laboratory tests. Seven (7) sessions were held, each lasting 20 minutes each, 22 volunteers allocated into two groups, sedentary and physically active. Measures ultrasound image were collected at baseline, pre-treatment and post-treatment period period and serum biochemical parameters (lipid profile, liver and kidney) for the pre-treatment and post-treatment.

详细描述

The demand for treatments for localized adiposity reduction increasingly gaining ground in beauty clinics due to the constant search for the perfect body and the current standards of beauty. The localized adiposity is characterized by a hypertrophy of unilocular fat cells that occurs in some parts of the body, especially the flanks and abdomen and often food programs combined with physical activity are not enough and requires a complementary treatment for redefinition of body shapes. The radio frequency is a non-invasive technique that emits electromagnetic waves generate heat in the skin layers. The technique is indicated for the treatment of edema fibro geloid (EGF), wrinkles, sagging and is also observed lipolytic effect acting directly at the level of accumulated fat cells helping to reduce the fat layer. With this vision, the investigators seek to evaluate the effects of Radio Frequency on localized f in patients who have this fat in the abdominal region, comparing a group of sedentary women with a group of women engaged in physical activities. Also will evaluate biochemical and anthropometric parameters so that they can provide indications about the effects of radio frequency in the human body.

This is a pilot study. The sample will consist of 30 females volunteers who participate, respecting the criteria for inclusion and exclusion previously cited by reading and signing the Informed Consent and Clarified.

The sample consists of 30 participants, divided into two groups, with 15 individuals will be regular exercise practitioners and 15 are sedentary, with participants from each group will undergo a 4-week control period between the first (base period) and second (pre-treatment) evaluations. Participants will be instructed to not change their respective routine activities.

For physical activity practitioner should perform at least 150 minutes of aerobic exercise of moderate intensity in the week, or at least 75 minutes of vigorous physical activity, or even that combine physical activity of moderate and vigorous intensity during the week. Both groups will make 12 sessions on individual radio frequency applications, twice a week, total of 6 weeks treatment.

To monitor the results, diagnostic ultrasound will be used to measure the fat layer. To collect the individual will be in the supine position with a pillow under the lumbar spine. The head will be positioned above the navel and the fat thickness is measured from the inner layer of the skin to the aponeurosis of the rectus abdominis muscle in the middle of the Alba line area. To measure the fatty layer of flanks the head that was in the umbilicus will be displaced laterally with the individual still in the supine position. The head is in the transverse plane will be asked to the individual who holds the air on exhalation to collect the image. The fat thickness measurements are made with a linear probe (7.5 MHz) with a depth of 4 to 5cm. The parameters used in this study have been previously tested and showed no health risk.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Sedentary
  • physically active

排除标准

  • 未提供

研究组 & 干预措施

Dermosux RF

Experimental

The group received the radio frequency for 20 minutes with the frequency of 1 MHz with 40 W.

干预措施: Dermosux RF (Device)

结局指标

主要结局

Use of radio frequency reduce the layer of fat in abdominal area

时间窗: 7 weeks

次要结局

未报告次要终点

研究者

发起方
Federal University of Health Science of Porto Alegre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Viana da Rosa

Adjunct Professor

Federal University of Health Science of Porto Alegre

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