Effects of Shockwave Therapy Versus Radiofrequency
- Conditions
- Cardiovascular Risk FactorPhotoagingMetabolic Disease
- Interventions
- Device: Shock wave therapyDevice: RadiofrequencyDevice: Aerobic exercise
- Registration Number
- NCT04282057
- Lead Sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- Women aged 18 to 60 years
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description shockwave therapy group Shock wave therapy This group performed aerobic exercise just after shock wave therapy in the abdominal region. radiofrequency group Radiofrequency This group performed aerobic exercise just after radiofrequency in the abdominal region. control group Aerobic exercise This group only performed aerobic exercise.
- Primary Outcome Measures
Name Time Method Body composition- muscle mass 6 weeks after muscle mass in kilograms
Body composition- fat mass 6 weeks after fat mass in kilograms
Body composition- visceral fat 6 weeks after visceral fat
Body composition- body mass 6 weeks after body mass in kilograms
Cutaneous abdominal tissue thickness 6 weeks after Measurement of the cutaneous fold by ultrasonography
Glycerol concentration 6 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 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
Inflammatory markers concentration (IL6, CRP, TNF) 6 weeks after Blood analysis collection carried out with help from an clinical analysis technician
Body composition- fat body areas 6 weeks after percentage of fat distributed by body areas
Subcutaneous abdominal tissue thickness 6 weeks after Measurement of the subcutaneous adipose fold by ultrasonography
Adipometry 6 weeks after Adipometry consists of measuring skinfold thickness
Nitrous oxide concentration 6 weeks after Blood analysis collection carried out with help from an clinical analysis technician
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
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
- Secondary Outcome Measures
Name Time Method 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 6 weeks after Satisfaction questionnaire to evaluate the final results according to the participant
Trial Locations
- Locations (1)
Andreia Noites
🇵🇹Vila Nova de Gaia, Porto, Portugal