Effects of Shockwave Therapy Versus Radiofrequency

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cardiovascular Risk Factor, Metabolic Disease, Photoaging

Intervention / Treatment
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* Device: Radiofrequency
* Device: Aerobic exercise
* Device: Shock wave therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18 to 60 years Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: shockwave therapy group<br>This group performed aerobic exercise just after shock wave therapy in the abdominal region. | Device: Shock wave therapy<br>* 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.<br>|
| Experimental: radiofrequency group<br>This group performed aerobic exercise just after radiofrequency in the abdominal region. | Device: Radiofrequency<br>* 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.<br>|
| Active Comparator: control group<br>This group only performed aerobic exercise. | Device: Aerobic exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shock wave therapy, radiofrequency, adipose tissue, skin flaccidity, aerobic exercise