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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| shockwave therapy group | Experimental | This group performed aerobic exercise just after shock wave therapy in the abdominal region. |
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| radiofrequency group | Experimental | This group performed aerobic exercise just after radiofrequency in the abdominal region. |
|
| control group | Active Comparator | This group only performed aerobic exercise. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous abdominal tissue thickness | Measurement of the cutaneous fold by ultrasonography | Baseline |
| Cutaneous abdominal tissue thickness | Measurement of the cutaneous fold by ultrasonography | 3 weeks after |
| Cutaneous abdominal tissue thickness | Measurement of the cutaneous fold by ultrasonography | 6 weeks after |
| Subcutaneous abdominal tissue thickness | Measurement of the subcutaneous adipose fold by ultrasonography | Baseline |
| Subcutaneous abdominal tissue thickness | Measurement of the subcutaneous adipose fold by ultrasonography | 3 weeks after |
| Subcutaneous abdominal tissue thickness | Measurement of the subcutaneous adipose fold by ultrasonography | 6 weeks after |
| Glycerol concentration | Blood analysis collection carried out with help from an clinical analysis technician | Baseline |
| Glycerol concentration | Blood analysis collection carried out with help from an clinical analysis technician |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andreia Noites | Vila Nova de Gaia | Porto District | 4400-330 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21981441 | Background | 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. | |
| 28590827 | Background | 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. |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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|
| Aerobic exercise | Device | 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 | Device | 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. |
|
| 3 weeks after |
| Glycerol concentration | Blood analysis collection carried out with help from an clinical analysis technician | 6 weeks after |
| Lipid profile (LDL, HDL and triglyceride concentrations) | Blood analysis collection carried out with help from an clinical analysis technician | Baseline |
| Lipid profile (LDL, HDL and triglyceride concentrations) | Blood analysis collection carried out with help from an clinical analysis technician | 3 weeks after |
| Lipid profile (LDL, HDL and triglyceride concentrations) | Blood analysis collection carried out with help from an clinical analysis technician | 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 | 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 | 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 | 6 weeks after |
| Adipometry | Adipometry consists of measuring skinfold thickness | Baseline |
| Adipometry | Adipometry consists of measuring skinfold thickness | 3 weeks after |
| Adipometry | Adipometry consists of measuring skinfold thickness | 6 weeks after |
| Inflammatory markers concentration (IL6, CRP, TNF) | Blood analysis collection carried out with help from an clinical analysis technician | Baseline |
| Inflammatory markers concentration (IL6, CRP, TNF) | Blood analysis collection carried out with help from an clinical analysis technician | 3 weeks after |
| Inflammatory markers concentration (IL6, CRP, TNF) | Blood analysis collection carried out with help from an clinical analysis technician | 6 weeks after |
| Nitrous oxide concentration | Blood analysis collection carried out with help from an clinical analysis technician | Baseline |
| Nitrous oxide concentration | Blood analysis collection carried out with help from an clinical analysis technician | 3 weeks after |
| Nitrous oxide concentration | Blood analysis collection carried out with help from an clinical analysis technician | 6 weeks after |
| Body composition- body mass | body mass in kilograms | Baseline |
| Body composition- body mass | body mass in kilograms | 3 weeks after |
| Body composition- body mass | body mass in kilograms | 6 weeks after |
| Body composition- muscle mass | muscle mass in kilograms | Baseline |
| Body composition- muscle mass | muscle mass in kilograms | 3 weeks after |
| Body composition- muscle mass | muscle mass in kilograms | 6 weeks after |
| Body composition- fat mass | fat mass in kilograms | Baseline |
| Body composition- fat mass | fat mass in kilograms | 3 weeks after |
| Body composition- fat mass | fat mass in kilograms | 6 weeks after |
| Body composition- visceral fat | visceral fat | Baseline |
| Body composition- visceral fat | visceral fat | 3 weeks after |
| Body composition- visceral fat | visceral fat | 6 weeks after |
| Body composition- fat body areas | percentage of fat distributed by body areas | Baseline |
| Body composition- fat body areas | percentage of fat distributed by body areas | 3 weeks after |
| Body composition- fat body areas | percentage of fat distributed by body areas | 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 | 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 | 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 | 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 | Baseline |
| Photography | Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat | 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 | 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) |
| 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) | 6 weeks after |
| skin flaccidity and localized fat in the abdomen region | Satisfaction questionnaire to evaluate the final results according to the participant | Baseline |
| skin flaccidity and localized fat in the abdomen region | Satisfaction questionnaire to evaluate the final results according to the participant | 3 weeks after |
| skin flaccidity and localized fat in the abdomen region | Satisfaction questionnaire to evaluate the final results according to the participant | 6 weeks after |
| 31254455 | Background | 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. |
| 31157522 | Background | 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. |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |