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.
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. Radiofrequency is an electromagnetic wave that when applied to skin, generates oscillating magnetic fields that move electrically charged particles producing heat in the tissues. The amount of heat produced is dependent on resistance. Shock wave therapy consists of the application of high energy acoustic waves whose main characteristic is the production of a high pressure pulse induced in a short period of time. This will generate mechanical pressure waves in the tissues, promoting cavitation, with the formation of gas bubbles in the intervening fluids and an increase in local temperature. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Radiofrequency protocol - The radiofrequency protocol was performed in dorsal decubitus, with the head elevated at 45 degrees. The application was in capacitive mode, with a 7cm electrode, always in movement. The duration of the application was established in 15 minutes, maintaining the local temperature between 40 to 42 celsius degrees at the epidermis.
Aerobic exercise protocol - 40 minutes of aerobic moderate-intensity exercise (45-55% of reserve heart rate) using Karvonen's formula, performed on a cycloergometer. The duration of the exercise was divided into three parts: warm-up (5 minutes); body (30 minutes); and cooling (from 5 to 10 minutes). The entire protocol was monitored through the Polar® brand heart rate monitor and watch.
Andreia Noites
Vila Nova de Gaia, Porto District, Portugal
Cutaneous abdominal tissue thickness
Measurement of the cutaneous fold by ultrasonography
Time frame: Baseline
Cutaneous abdominal tissue thickness
Measurement of the cutaneous fold by ultrasonography
Time frame: 3 weeks after
Cutaneous abdominal tissue thickness
Measurement of the cutaneous fold by ultrasonography
Time frame: 6 weeks after
Subcutaneous abdominal tissue thickness
Measurement of the subcutaneous adipose fold by ultrasonography
Time frame: Baseline
Subcutaneous abdominal tissue thickness
Measurement of the subcutaneous adipose fold by ultrasonography
Time frame: 3 weeks after
Subcutaneous abdominal tissue thickness
Measurement of the subcutaneous adipose fold by ultrasonography
Time frame: 6 weeks after
Glycerol concentration
Blood analysis collection carried out with help from an clinical analysis technician
Time frame: Baseline
Glycerol concentration
Blood analysis collection carried out with help from an clinical analysis technician
Time frame: 3 weeks after
Glycerol concentration
Blood analysis collection carried out with help from an clinical analysis technician
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The shock wave device corresponds to the BTL-6000 X-Wave TM with a 20mm transmitter multifocal. The parameters used correspond to the pressure set between 2.8 and 3.5 bar, frequency 15 hertz and 3000 pulses per 10x15 cm area. It was used as a means contact gel for ultrasound, reference 033-051. In this procedure the participants found themselves in the supine position, with a pillow under the head and with the bending knees.
Time frame: 6 weeks after
Lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection carried out with help from an clinical analysis technician
Time frame: Baseline
Lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection carried out with help from an clinical analysis technician
Time frame: 3 weeks after
Lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection carried out with help from an clinical analysis technician
Time frame: 6 weeks after
Perimetry
Perimetry consists of measuring circumferences. In this case, of the waist at the navel area, 3 cm below it and in the hip area
Time frame: Baseline
Perimetry
Perimetry consists of measuring circumferences. In this case, of the waist at the navel area, 3 cm below it and in the hip area
Time frame: 3 weeks after
Perimetry
Perimetry consists of measuring circumferences. In this case, of the waist at the navel area, 3 cm below it and in the hip area
Time frame: 6 weeks after
Adipometry
Adipometry consists of measuring skinfold thickness
Time frame: Baseline
Adipometry
Adipometry consists of measuring skinfold thickness
Time frame: 3 weeks after
Adipometry
Adipometry consists of measuring skinfold thickness
Time frame: 6 weeks after
Inflammatory markers concentration (IL6, CRP, TNF)
Blood analysis collection carried out with help from an clinical analysis technician
Time frame: Baseline
Inflammatory markers concentration (IL6, CRP, TNF)
Blood analysis collection carried out with help from an clinical analysis technician
Time frame: 3 weeks after
Inflammatory markers concentration (IL6, CRP, TNF)
Blood analysis collection carried out with help from an clinical analysis technician
Time frame: 6 weeks after
Nitrous oxide concentration
Blood analysis collection carried out with help from an clinical analysis technician
Time frame: Baseline
Nitrous oxide concentration
Blood analysis collection carried out with help from an clinical analysis technician
Time frame: 3 weeks after
Nitrous oxide concentration
Blood analysis collection carried out with help from an clinical analysis technician
Time frame: 6 weeks after
Body composition- body mass
body mass in kilograms
Time frame: Baseline
Body composition- body mass
body mass in kilograms
Time frame: 3 weeks after
Body composition- body mass
body mass in kilograms
Time frame: 6 weeks after
Body composition- muscle mass
muscle mass in kilograms
Time frame: Baseline
Body composition- muscle mass
muscle mass in kilograms
Time frame: 3 weeks after
Body composition- muscle mass
muscle mass in kilograms
Time frame: 6 weeks after
Body composition- fat mass
fat mass in kilograms
Time frame: Baseline
Body composition- fat mass
fat mass in kilograms
Time frame: 3 weeks after
Body composition- fat mass
fat mass in kilograms
Time frame: 6 weeks after
Body composition- visceral fat
visceral fat
Time frame: Baseline
Body composition- visceral fat
visceral fat
Time frame: 3 weeks after
Body composition- visceral fat
visceral fat
Time frame: 6 weeks after
Body composition- fat body areas
percentage of fat distributed by body areas
Time frame: Baseline
Body composition- fat body areas
percentage of fat distributed by body areas
Time frame: 3 weeks after
Body composition- fat body areas
percentage of fat distributed by body areas
Time frame: 6 weeks after
Thermography
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
Time frame: Baseline
Thermography
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
Time frame: 3 weeks after
Thermography
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
Time frame: 6 weeks after
Photography
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Time frame: Baseline
Photography
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Time frame: 3 weeks after
Photography
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Time frame: 6 weeks after
skin flaccidity
Investigator Assessment Skin Laxity Scoring System - Questionnaire that evaluates skin flaccidity and scores from 0 to 4. (As the subjectivity assessment of this outcome, the investigator who evaluates is blind to the group that the participants are allocated, in order to avoid partial scores)
Time frame: Baseline
skin flaccidity
Investigator Assessment Skin Laxity Scoring System - Questionnaire that evaluates skin flaccidity and scores from 0 to 4. (As the subjectivity assessment of this outcome, the investigator who evaluates is blind to the group that the participants are allocated, in order to avoid partial scores)
Time frame: 3 weeks after
skin flaccidity
Investigator Assessment Skin Laxity Scoring System - Questionnaire that evaluates skin flaccidity and scores from 0 to 4. (As the subjectivity assessment of this outcome, the investigator who evaluates is blind to the group that the participants are allocated, in order to avoid partial scores)
Time frame: 6 weeks after
skin flaccidity and localized fat in the abdomen region
Satisfaction questionnaire to evaluate the final results according to the participant
Time frame: Baseline
skin flaccidity and localized fat in the abdomen region
Satisfaction questionnaire to evaluate the final results according to the participant
Time frame: 3 weeks after
skin flaccidity and localized fat in the abdomen region
Satisfaction questionnaire to evaluate the final results according to the participant
Time frame: 6 weeks after