Clinical trial NCT04282057: Effects of Shockwave Therapy Versus Radiofrequency
Official title: Effect of an Aerobic Exercise Program Associated With Shock Wave Therapy Versus Radiofrequency on Skin and Subcutaneous Tissue: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Metabolic Disease
Photoaging
Keywords: shock wave therapy
radiofrequency
adipose tissue
skin flaccidity
aerobic exercise
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cutaneous abdominal tissue thickness
timeFrame: Baseline
measure: Cutaneous abdominal tissue thickness
timeFrame: 3 weeks after
measure: Cutaneous abdominal tissue thickness
timeFrame: 6 weeks after
measure: Subcutaneous abdominal tissue thickness
timeFrame: Baseline
measure: Subcutaneous abdominal tissue thickness
timeFrame: 3 weeks after
measure: Subcutaneous abdominal tissue thickness
timeFrame: 6 weeks after
measure: Glycerol concentration
timeFrame: Baseline
measure: Glycerol concentration
timeFrame: 3 weeks after
measure: Glycerol concentration
timeFrame: 6 weeks after
measure: Lipid profile (LDL, HDL and triglyceride concentrations)
timeFrame: Baseline
measure: Lipid profile (LDL, HDL and triglyceride concentrations)
timeFrame: 3 weeks after
measure: Lipid profile (LDL, HDL and triglyceride concentrations)
timeFrame: 6 weeks after
measure: Perimetry
timeFrame: Baseline
measure: Perimetry
timeFrame: 3 weeks after
measure: Perimetry
timeFrame: 6 weeks after
measure: Adipometry
timeFrame: Baseline
measure: Adipometry
timeFrame: 3 weeks after
measure: Adipometry
timeFrame: 6 weeks after
measure: Inflammatory markers concentration (IL6, CRP, TNF)
timeFrame: Baseline
measure: Inflammatory markers concentration (IL6, CRP, TNF)
timeFrame: 3 weeks after
measure: Inflammatory markers concentration (IL6, CRP, TNF)
timeFrame: 6 weeks after
measure: Nitrous oxide concentration
timeFrame: Baseline
measure: Nitrous oxide concentration
timeFrame: 3 weeks after
measure: Nitrous oxide concentration
timeFrame: 6 weeks after
measure: Body composition- body mass
timeFrame: Baseline
measure: Body composition- body mass
timeFrame: 3 weeks after
measure: Body composition- body mass
timeFrame: 6 weeks after
measure: Body composition- muscle mass
timeFrame: Baseline
measure: Body composition- muscle mass
timeFrame: 3 weeks after
measure: Body composition- muscle mass
timeFrame: 6 weeks after
measure: Body composition- fat mass
timeFrame: Baseline
measure: Body composition- fat mass
timeFrame: 3 weeks after
measure: Body composition- fat mass
timeFrame: 6 weeks after
measure: Body composition- visceral fat
timeFrame: Baseline
measure: Body composition- visceral fat
timeFrame: 3 weeks after
measure: Body composition- visceral fat
timeFrame: 6 weeks after
measure: Body composition- fat body areas
timeFrame: Baseline
measure: Body composition- fat body areas
timeFrame: 3 weeks after
measure: Body composition- fat body areas
timeFrame: 6 weeks after
measure: Thermography
timeFrame: Baseline
measure: Thermography
timeFrame: 3 weeks after
measure: Thermography
timeFrame: 6 weeks after
measure: Photography
timeFrame: Baseline
measure: Photography
timeFrame: 3 weeks after
measure: Photography
timeFrame: 6 weeks after
Secondary outcomes:
measure: skin flaccidity
timeFrame: Baseline
measure: skin flaccidity
timeFrame: 3 weeks after
measure: skin flaccidity
timeFrame: 6 weeks after
measure: skin flaccidity and localized fat in the abdomen region
timeFrame: Baseline
measure: skin flaccidity and localized fat in the abdomen region
timeFrame: 3 weeks after
measure: skin flaccidity and localized fat in the abdomen region
timeFrame: 6 weeks after
Other outcomes:
Locations:
city: Vila Nova de Gaia
country: Portugal
facility: Andreia Noites
state: Porto
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.