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临床试验/NCT04282057
NCT04282057已完成不适用

Effect of an Aerobic Exercise Program Associated With Shock Wave Therapy Versus Radiofrequency on Skin and Subcutaneous Tissue: Randomized Controlled Study

Escola Superior de Tecnologia da Saúde do Porto2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Body composition- muscle mass

研究概览

简要总结

The main objective of this study is to compare the effect of 6 sessions of shock wave therapy versus radiofrequency followed by a protocol of moderate aerobic exercise, in the reduction of adiposity and abdominal flaccidity, in females between 18 and 60 years old. As a secondary objective, it is intended to understand the mechanism of fat mobilization by these two therapies.

详细描述

With the increasing awareness of the population regarding the high rate of obesity and the number of deaths per year as a result of being overweight, treatments for reducing measures are increasingly sought.

The evidence shows that the accumulation of fat located in the abdominal region is a risk factor for dyslipidemia and arterial hypertension, and a reduction in waist circumference can reduce the potential risk of cardiovascular disease.

In addition to this concern, with the aging of the population and changes in body dimensions due to pregnancy or to a weight loss process, body flaccidity is also a growing cosmetic complaint, and the result is a less firm and pending skin.

Physical exercise is a very important agent for combating excess weight, with special attention to aerobic physical exercise, which is able to decrease body fat tissue and increase the oxidation of fatty acids by 5 to 10 times more than in resting state. The evidence points out that the exercise prescription to decrease fat mass should focus on a high volume of training (30 to 60 minutes) with moderate intensity (40 to 60% of Heart Rate Reserve), performed regularly and mobilizing large muscle groups.

In order to combat abdominal adiposity, as well as the flaccidity of the region, radiofrequency is presented as a possible complementary strategy.

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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18 to 60 years

排除标准

  • smoking and drinking habits;
  • athletes;
  • people with dietary restrictions;
  • participants who have had diets to lose weight in the last 3 months or who will start during the study;
  • pregnant women;
  • in postpartum less than one year;
  • breastfeeding;
  • intending to become pregnant during the study period;
  • patients with electronic or metallic devices (pacemaker, IUD);
  • individuals with metabolic (including dyslipidemias);
  • hematological and renal disorders;
  • individuals with dermatological changes;
  • cardiovascular, respiratory, digestive, orthopedic, rheumatological and oncological pathologies;
  • changes in the immune system or with acute inflammatory processes;
  • changes in sensitivity or subject to medication (anti-coagulants, corticosteroids up to 6 weeks before, non-steroidal anti-inflammatory drugs, antihistamines, diuretics)

结局指标

主要结局

Body composition- muscle mass

时间窗: 6 weeks after

muscle mass in kilograms

Body composition- fat mass

时间窗: 6 weeks after

fat mass in kilograms

Body composition- visceral fat

时间窗: 6 weeks after

visceral fat

Body composition- body mass

时间窗: 6 weeks after

body mass in kilograms

Cutaneous abdominal tissue thickness

时间窗: 6 weeks after

Measurement of the cutaneous fold by ultrasonography

Glycerol concentration

时间窗: 6 weeks after

Blood analysis collection carried out with help from an clinical analysis technician

Lipid profile (LDL, HDL and triglyceride concentrations)

时间窗: 6 weeks after

Blood analysis collection carried out with help from an clinical analysis technician

Perimetry

时间窗: 6 weeks after

Perimetry consists of measuring circumferences. In this case, of the waist at the navel area, 3 cm below it and in the hip area

Inflammatory markers concentration (IL6, CRP, TNF)

时间窗: 6 weeks after

Blood analysis collection carried out with help from an clinical analysis technician

Body composition- fat body areas

时间窗: 6 weeks after

percentage of fat distributed by body areas

Subcutaneous abdominal tissue thickness

时间窗: 6 weeks after

Measurement of the subcutaneous adipose fold by ultrasonography

Photography

时间窗: 6 weeks after

Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat

Adipometry

时间窗: 6 weeks after

Adipometry consists of measuring skinfold thickness

Nitrous oxide concentration

时间窗: 6 weeks after

Blood analysis collection carried out with help from an clinical analysis technician

Thermography

时间窗: 6 weeks after

Thermography is used to assess the temperature of the skin surface, and it is also possible to suppose changes in blood flow and vascularization with this outcome

次要结局

  • skin flaccidity(6 weeks after)
  • skin flaccidity and localized fat in the abdomen region(6 weeks after)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreia Noites

Teacher

Escola Superior de Tecnologia da Saúde do Porto

研究点 (2)

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