Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2020-02-22
2020-06-19
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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shockwave therapy group
This group performed aerobic exercise just after shock wave therapy in the abdominal region.
Shock wave therapy
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.
radiofrequency group
This group performed aerobic exercise just after radiofrequency in the abdominal region.
Radiofrequency
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.
control group
This group only performed aerobic exercise.
Aerobic exercise
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.
Interventions
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Radiofrequency
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
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.
Shock wave therapy
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
60 Years
FEMALE
Yes
Sponsors
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Escola Superior de Tecnologia da Saúde do Porto
OTHER
Responsible Party
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Andreia Noites
Teacher
Locations
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Andreia Noites
Vila Nova de Gaia, Porto District, Portugal
Countries
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References
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Adatto MA, Adatto-Neilson R, Novak P, Krotz A, Haller G. Body shaping with acoustic wave therapy AWT((R))/EPAT((R)): randomized, controlled study on 14 subjects. J Cosmet Laser Ther. 2011 Dec;13(6):291-6. doi: 10.3109/14764172.2011.630089.
Modena DAO, da Silva CN, Grecco C, Guidi RM, Moreira RG, Coelho AA, Sant'Ana E, de Souza JR. Extracorporeal shockwave: mechanisms of action and physiological aspects for cellulite, body shaping, and localized fat-Systematic review. J Cosmet Laser Ther. 2017 Oct;19(6):314-319. doi: 10.1080/14764172.2017.1334928. Epub 2017 Jun 7.
Noites A, Vale AL, Pereira AS, Morais A, Vilarinho R, Carvalho P, Amorim M, Moreira T, Mendonca A. Effect of an aerobic exercise session combined with abdominal radiofrequency on lipolytic activity in women: Randomized control trial. J Cosmet Dermatol. 2020 Mar;19(3):638-645. doi: 10.1111/jocd.13056. Epub 2019 Jun 29.
Vale AL, Pereira AS, Morais A, de Carvalho P, Vilarinho R, Mendonca A, Noites A. Effect of four sessions of aerobic exercise with abdominal radiofrequency in adipose tissue in healthy women: Randomized control trial. J Cosmet Dermatol. 2020 Feb;19(2):359-367. doi: 10.1111/jocd.13036. Epub 2019 Jun 3.
Other Identifiers
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AN-009
Identifier Type: -
Identifier Source: org_study_id