Effects of Shockwave Therapy Versus Radiofrequency

Sponsor

Escola Superior de Tecnologia da Saúde do Porto (Other)

Overall Status

Completed

CT.gov ID

NCT04282057

Collaborator

(none)

Enrollment

Location

Arms

3.9

Actual Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Risk Factor Metabolic Disease Photoaging	Device: Radiofrequency Device: Aerobic exercise Device: Shock wave therapy	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 22, 2020

Actual Primary Completion Date :

Apr 25, 2020

Actual Study Completion Date :

Jun 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: shockwave therapy group This group performed aerobic exercise just after shock wave therapy in the abdominal region.	Device: 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.
Experimental: radiofrequency group This group performed aerobic exercise just after radiofrequency in the abdominal region.	Device: 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.
Active Comparator: control group This group only performed aerobic exercise.	Device: 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.

Arm

Intervention/Treatment

Experimental: shockwave therapy group

This group performed aerobic exercise just after shock wave therapy in the abdominal region.

Device: 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.

Experimental: radiofrequency group

This group performed aerobic exercise just after radiofrequency in the abdominal region.

Device: 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.

Active Comparator: control group

This group only performed aerobic exercise.

Device: 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.

Outcome Measures

Primary Outcome Measures

Cutaneous abdominal tissue thickness [Baseline]
Measurement of the cutaneous fold by ultrasonography
Cutaneous abdominal tissue thickness [3 weeks after]
Measurement of the cutaneous fold by ultrasonography
Cutaneous abdominal tissue thickness [6 weeks after]
Measurement of the cutaneous fold by ultrasonography
Subcutaneous abdominal tissue thickness [Baseline]
Measurement of the subcutaneous adipose fold by ultrasonography
Subcutaneous abdominal tissue thickness [3 weeks after]
Measurement of the subcutaneous adipose fold by ultrasonography
Subcutaneous abdominal tissue thickness [6 weeks after]
Measurement of the subcutaneous adipose fold by ultrasonography
Glycerol concentration [Baseline]
Blood analysis collection carried out with help from an clinical analysis technician
Glycerol concentration [3 weeks after]
Blood analysis collection carried out with help from an clinical analysis technician
Glycerol concentration [6 weeks after]
Blood analysis collection carried out with help from an clinical analysis technician
Lipid profile (LDL, HDL and triglyceride concentrations) [Baseline]
Blood analysis collection carried out with help from an clinical analysis technician
Lipid profile (LDL, HDL and triglyceride concentrations) [3 weeks after]
Blood analysis collection carried out with help from an clinical analysis technician
Lipid profile (LDL, HDL and triglyceride concentrations) [6 weeks after]
Blood analysis collection carried out with help from an clinical analysis technician
Perimetry [Baseline]
Perimetry consists of measuring circumferences. In this case, of the waist at the navel area, 3 cm below it and in the hip area
Perimetry [3 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
Perimetry [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
Adipometry [Baseline]
Adipometry consists of measuring skinfold thickness
Adipometry [3 weeks after]
Adipometry consists of measuring skinfold thickness
Adipometry [6 weeks after]
Adipometry consists of measuring skinfold thickness
Inflammatory markers concentration (IL6, CRP, TNF) [Baseline]
Blood analysis collection carried out with help from an clinical analysis technician
Inflammatory markers concentration (IL6, CRP, TNF) [3 weeks after]
Blood analysis collection carried out with help from an clinical analysis technician
Inflammatory markers concentration (IL6, CRP, TNF) [6 weeks after]
Blood analysis collection carried out with help from an clinical analysis technician
Nitrous oxide concentration [Baseline]
Blood analysis collection carried out with help from an clinical analysis technician
Nitrous oxide concentration [3 weeks after]
Blood analysis collection carried out with help from an clinical analysis technician
Nitrous oxide concentration [6 weeks after]
Blood analysis collection carried out with help from an clinical analysis technician
Body composition- body mass [Baseline]
body mass in kilograms
Body composition- body mass [3 weeks after]
body mass in kilograms
Body composition- body mass [6 weeks after]
body mass in kilograms
Body composition- muscle mass [Baseline]
muscle mass in kilograms
Body composition- muscle mass [3 weeks after]
muscle mass in kilograms
Body composition- muscle mass [6 weeks after]
muscle mass in kilograms
Body composition- fat mass [Baseline]
fat mass in kilograms
Body composition- fat mass [3 weeks after]
fat mass in kilograms
Body composition- fat mass [6 weeks after]
fat mass in kilograms
Body composition- visceral fat [Baseline]
visceral fat
Body composition- visceral fat [3 weeks after]
visceral fat
Body composition- visceral fat [6 weeks after]
visceral fat
Body composition- fat body areas [Baseline]
percentage of fat distributed by body areas
Body composition- fat body areas [3 weeks after]
percentage of fat distributed by body areas
Body composition- fat body areas [6 weeks after]
percentage of fat distributed by body areas
Thermography [Baseline]
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
Thermography [3 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
Thermography [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
Photography [Baseline]
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Photography [3 weeks after]
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Photography [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

Secondary Outcome Measures

skin flaccidity [Baseline]
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)
skin flaccidity [3 weeks after]
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)
skin flaccidity [6 weeks after]
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)
skin flaccidity and localized fat in the abdomen region [Baseline]
Satisfaction questionnaire to evaluate the final results according to the participant
skin flaccidity and localized fat in the abdomen region [3 weeks after]
Satisfaction questionnaire to evaluate the final results according to the participant
skin flaccidity and localized fat in the abdomen region [6 weeks after]
Satisfaction questionnaire to evaluate the final results according to the participant

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)