Cardiovascular Risk FactorNCT04282057
Effects of Shockwave Therapy Versus Radiofrequency
A study testing Radiofrequency, Aerobic exercise and Shock wave therapy in people with Cardiovascular Risk Factor and Metabolic Disease, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Metabolic Disease, Photoaging
- What is being tested?
- Radiofrequency, Aerobic exercise and Shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 22 Feb 2020to 19 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18 to 60 years
Who cannot join
- 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;
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Aerobic Exercise Program Associated With Shock Wave Therapy Versus Radiofrequency on Skin and Subcutaneous Tissue: Randomized Controlled Study
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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor, Metabolic Disease, Photoaging
- Being tested
- Radiofrequency, Aerobic exercise, Shock wave therapy
- Keywords
- shock wave therapy, radiofrequency, adipose tissue, skin flaccidity, aerobic exercise
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyDevice
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.
Aerobic exerciseDevice
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 therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| shockwave therapy group | Experimental | This group performed aerobic exercise just after shock wave therapy in the abdominal region. Receives: Device: Shock wave therapy |
| radiofrequency group | Experimental | This group performed aerobic exercise just after radiofrequency in the abdominal region. Receives: Device: Radiofrequency |
| control group | Active comparator | This group only performed aerobic exercise. Receives: Device: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous abdominal tissue thickness
Measurement of the cutaneous fold by ultrasonography
Measured: Baseline
Cutaneous abdominal tissue thickness
Measurement of the cutaneous fold by ultrasonography
Measured: 3 weeks after
Cutaneous abdominal tissue thickness
Measurement of the cutaneous fold by ultrasonography
Measured: 6 weeks after
Subcutaneous abdominal tissue thickness
Measurement of the subcutaneous adipose fold by ultrasonography
Measured: Baseline
Subcutaneous abdominal tissue thickness
Measurement of the subcutaneous adipose fold by ultrasonography
Measured: 3 weeks after
Subcutaneous abdominal tissue thickness
Measurement of the subcutaneous adipose fold by ultrasonography
Measured: 6 weeks after
Glycerol concentration
Blood analysis collection carried out with help from an clinical analysis technician
Measured: Baseline
Glycerol concentration
Blood analysis collection carried out with help from an clinical analysis technician
Measured: 3 weeks after
Glycerol concentration
Blood analysis collection carried out with help from an clinical analysis technician
Measured: 6 weeks after
Lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection carried out with help from an clinical analysis technician
Measured: Baseline
Lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection carried out with help from an clinical analysis technician
Measured: 3 weeks after
Lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection carried out with help from an clinical analysis technician
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks after
Adipometry
Adipometry consists of measuring skinfold thickness
Measured: Baseline
Adipometry
Adipometry consists of measuring skinfold thickness
Measured: 3 weeks after
Adipometry
Adipometry consists of measuring skinfold thickness
Measured: 6 weeks after
Inflammatory markers concentration (IL6, CRP, TNF)
Blood analysis collection carried out with help from an clinical analysis technician
Measured: Baseline
Inflammatory markers concentration (IL6, CRP, TNF)
Blood analysis collection carried out with help from an clinical analysis technician
Measured: 3 weeks after
Inflammatory markers concentration (IL6, CRP, TNF)
Blood analysis collection carried out with help from an clinical analysis technician
Measured: 6 weeks after
Nitrous oxide concentration
Blood analysis collection carried out with help from an clinical analysis technician
Measured: Baseline
Nitrous oxide concentration
Blood analysis collection carried out with help from an clinical analysis technician
Measured: 3 weeks after
Nitrous oxide concentration
Blood analysis collection carried out with help from an clinical analysis technician
Measured: 6 weeks after
Body composition- body mass
body mass in kilograms
Measured: Baseline
Body composition- body mass
body mass in kilograms
Measured: 3 weeks after
Body composition- body mass
body mass in kilograms
Measured: 6 weeks after
Body composition- muscle mass
muscle mass in kilograms
Measured: Baseline
Body composition- muscle mass
muscle mass in kilograms
Measured: 3 weeks after
Body composition- muscle mass
muscle mass in kilograms
Measured: 6 weeks after
Body composition- fat mass
fat mass in kilograms
Measured: Baseline
Body composition- fat mass
fat mass in kilograms
Measured: 3 weeks after
Body composition- fat mass
fat mass in kilograms
Measured: 6 weeks after
Body composition- visceral fat
visceral fat
Measured: Baseline
Body composition- visceral fat
visceral fat
Measured: 3 weeks after
Body composition- visceral fat
visceral fat
Measured: 6 weeks after
Body composition- fat body areas
percentage of fat distributed by body areas
Measured: Baseline
Body composition- fat body areas
percentage of fat distributed by body areas
Measured: 3 weeks after
Body composition- fat body areas
percentage of fat distributed by body areas
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Photography
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Measured: 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
Measured: 6 weeks after
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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)
Measured: 6 weeks after
skin flaccidity and localized fat in the abdomen region
Satisfaction questionnaire to evaluate the final results according to the participant
Measured: Baseline
skin flaccidity and localized fat in the abdomen region
Satisfaction questionnaire to evaluate the final results according to the participant
Measured: 3 weeks after
skin flaccidity and localized fat in the abdomen region
Satisfaction questionnaire to evaluate the final results according to the participant
Measured: 6 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start22 Feb 2020
- Primary completion25 Apr 2020
- Study completion19 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282057
- Sponsor's protocol ID
- AN-009
- Status last verified
- Sep 2020
- First submitted
- 18 Feb 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21981441Modena 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.
PubMed 28590827Noites 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.
PubMed 31254455Vale 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.
PubMed 31157522
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Aerobic Exercise Program Associated With Shock Wave Therapy Versus Radiofrequency on Skin and Subcutaneous Tissue: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04282057
- Acronym / sponsor ID
- AN-009
- Conditions
- Cardiovascular Risk Factor, Metabolic Disease, Photoaging
- Keywords
- shock wave therapy, radiofrequency, adipose tissue, skin flaccidity, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- 22 Feb 2020 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 19 Jun 2020 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| shockwave therapy group | Experimental | Device: Shock wave therapyThis group performed aerobic exercise just after shock wave therapy in the abdominal region. |
| radiofrequency group | Experimental | Device: RadiofrequencyThis group performed aerobic exercise just after radiofrequency in the abdominal region. |
| control group | Active comparator | Device: Aerobic exerciseThis group only performed aerobic exercise. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 18 to 60 years
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiofrequencyRadiofrequency 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. | Device | radiofrequency group |
| Aerobic exerciseAerobic 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. | Device | control group |
| Shock wave therapyThe 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. | Device | shockwave therapy group |
Primary outcome
Cutaneous abdominal tissue thickness
Time frame: Baseline
Measurement of the cutaneous fold by ultrasonography
Cutaneous abdominal tissue thickness
Time frame: 3 weeks after
Measurement of the cutaneous fold by ultrasonography
Cutaneous abdominal tissue thickness
Time frame: 6 weeks after
Measurement of the cutaneous fold by ultrasonography
Subcutaneous abdominal tissue thickness
Time frame: Baseline
Measurement of the subcutaneous adipose fold by ultrasonography
Subcutaneous abdominal tissue thickness
Time frame: 3 weeks after
Measurement of the subcutaneous adipose fold by ultrasonography
Subcutaneous abdominal tissue thickness
Time frame: 6 weeks after
Measurement of the subcutaneous adipose fold by ultrasonography
Glycerol concentration
Time frame: Baseline
Blood analysis collection carried out with help from an clinical analysis technician
Glycerol concentration
Time frame: 3 weeks after
Blood analysis collection carried out with help from an clinical analysis technician
Glycerol concentration
Time frame: 6 weeks after
Blood analysis collection carried out with help from an clinical analysis technician
Lipid profile (LDL, HDL and triglyceride concentrations)
Time frame: Baseline
Blood analysis collection carried out with help from an clinical analysis technician
Lipid profile (LDL, HDL and triglyceride concentrations)
Time frame: 3 weeks after
Blood analysis collection carried out with help from an clinical analysis technician
Lipid profile (LDL, HDL and triglyceride concentrations)
Time frame: 6 weeks after
Blood analysis collection carried out with help from an clinical analysis technician
Perimetry
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline
Adipometry consists of measuring skinfold thickness
Adipometry
Time frame: 3 weeks after
Adipometry consists of measuring skinfold thickness
Adipometry
Time frame: 6 weeks after
Adipometry consists of measuring skinfold thickness
Inflammatory markers concentration (IL6, CRP, TNF)
Time frame: Baseline
Blood analysis collection carried out with help from an clinical analysis technician
Inflammatory markers concentration (IL6, CRP, TNF)
Time frame: 3 weeks after
Blood analysis collection carried out with help from an clinical analysis technician
Inflammatory markers concentration (IL6, CRP, TNF)
Time frame: 6 weeks after
Blood analysis collection carried out with help from an clinical analysis technician
Nitrous oxide concentration
Time frame: Baseline
Blood analysis collection carried out with help from an clinical analysis technician
Nitrous oxide concentration
Time frame: 3 weeks after
Blood analysis collection carried out with help from an clinical analysis technician
Nitrous oxide concentration
Time frame: 6 weeks after
Blood analysis collection carried out with help from an clinical analysis technician
Body composition- body mass
Time frame: Baseline
body mass in kilograms
Body composition- body mass
Time frame: 3 weeks after
body mass in kilograms
Body composition- body mass
Time frame: 6 weeks after
body mass in kilograms
Body composition- muscle mass
Time frame: Baseline
muscle mass in kilograms
Body composition- muscle mass
Time frame: 3 weeks after
muscle mass in kilograms
Body composition- muscle mass
Time frame: 6 weeks after
muscle mass in kilograms
Body composition- fat mass
Time frame: Baseline
fat mass in kilograms
Body composition- fat mass
Time frame: 3 weeks after
fat mass in kilograms
Body composition- fat mass
Time frame: 6 weeks after
fat mass in kilograms
Body composition- visceral fat
Time frame: Baseline
visceral fat
Body composition- visceral fat
Time frame: 3 weeks after
visceral fat
Body composition- visceral fat
Time frame: 6 weeks after
visceral fat
Body composition- fat body areas
Time frame: Baseline
percentage of fat distributed by body areas
Body composition- fat body areas
Time frame: 3 weeks after
percentage of fat distributed by body areas
Body composition- fat body areas
Time frame: 6 weeks after
percentage of fat distributed by body areas
Thermography
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Photography
Time frame: 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
Time frame: 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
6 secondary outcomes
skin flaccidity
Time frame: Baseline
skin flaccidity
Time frame: 3 weeks after
skin flaccidity
Time frame: 6 weeks after
skin flaccidity and localized fat in the abdomen region
Time frame: Baseline
skin flaccidity and localized fat in the abdomen region
Time frame: 3 weeks after
skin flaccidity and localized fat in the abdomen region
Time frame: 6 weeks after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Background: PubMed 21981441Adatto 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.
- Background: PubMed 28590827Modena 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.
- Background: PubMed 31254455Noites 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.
- Background: PubMed 31157522Vale 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency, Aerobic exercise and Shock wave therapy in people with Cardiovascular Risk Factor and Metabolic Disease, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous abdominal tissue thickness (time frame: Baseline). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04282057, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.