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Effects of Shockwave Therapy Versus Radiofrequency

Primary Purpose

Cardiovascular Risk Factor, Metabolic Disease, Photoaging

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Radiofrequency
Aerobic exercise
Shock wave therapy
Sponsored by
Escola Superior de Tecnologia da Saúde do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Risk Factor focused on measuring shock wave therapy, radiofrequency, adipose tissue, skin flaccidity, aerobic exercise

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Andreia Noites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

shockwave therapy group

radiofrequency group

control group

Arm Description

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

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

This group only performed aerobic exercise.

Outcomes

Primary Outcome Measures

Cutaneous abdominal tissue thickness
Measurement of the cutaneous fold by ultrasonography
Cutaneous abdominal tissue thickness
Measurement of the cutaneous fold by ultrasonography
Cutaneous abdominal tissue thickness
Measurement of the cutaneous fold by ultrasonography
Subcutaneous abdominal tissue thickness
Measurement of the subcutaneous adipose fold by ultrasonography
Subcutaneous abdominal tissue thickness
Measurement of the subcutaneous adipose fold by ultrasonography
Subcutaneous abdominal tissue thickness
Measurement of the subcutaneous adipose fold by ultrasonography
Glycerol concentration
Blood analysis collection carried out with help from an clinical analysis technician
Glycerol concentration
Blood analysis collection carried out with help from an clinical analysis technician
Glycerol concentration
Blood analysis collection carried out with help from an clinical analysis technician
Lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection carried out with help from an clinical analysis technician
Lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection carried out with help from an clinical analysis technician
Lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection carried out with help from an clinical analysis technician
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
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
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
Adipometry
Adipometry consists of measuring skinfold thickness
Adipometry
Adipometry consists of measuring skinfold thickness
Adipometry
Adipometry consists of measuring skinfold thickness
Inflammatory markers concentration (IL6, CRP, TNF)
Blood analysis collection carried out with help from an clinical analysis technician
Inflammatory markers concentration (IL6, CRP, TNF)
Blood analysis collection carried out with help from an clinical analysis technician
Inflammatory markers concentration (IL6, CRP, TNF)
Blood analysis collection carried out with help from an clinical analysis technician
Nitrous oxide concentration
Blood analysis collection carried out with help from an clinical analysis technician
Nitrous oxide concentration
Blood analysis collection carried out with help from an clinical analysis technician
Nitrous oxide concentration
Blood analysis collection carried out with help from an clinical analysis technician
Body composition- body mass
body mass in kilograms
Body composition- body mass
body mass in kilograms
Body composition- body mass
body mass in kilograms
Body composition- muscle mass
muscle mass in kilograms
Body composition- muscle mass
muscle mass in kilograms
Body composition- muscle mass
muscle mass in kilograms
Body composition- fat mass
fat mass in kilograms
Body composition- fat mass
fat mass in kilograms
Body composition- fat mass
fat mass in kilograms
Body composition- visceral fat
visceral fat
Body composition- visceral fat
visceral fat
Body composition- visceral fat
visceral fat
Body composition- fat body areas
percentage of fat distributed by body areas
Body composition- fat body areas
percentage of fat distributed by body areas
Body composition- fat body areas
percentage of fat distributed by body areas
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
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
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
Photography
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Photography
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Photography
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
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
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
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
Satisfaction questionnaire to evaluate the final results according to the participant
skin flaccidity and localized fat in the abdomen region
Satisfaction questionnaire to evaluate the final results according to the participant
skin flaccidity and localized fat in the abdomen region
Satisfaction questionnaire to evaluate the final results according to the participant

Full Information

First Posted
February 18, 2020
Last Updated
September 28, 2020
Sponsor
Escola Superior de Tecnologia da Saúde do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT04282057
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 22, 2020 (Actual)
Primary Completion Date
April 25, 2020 (Actual)
Study Completion Date
June 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Tecnologia da Saúde do Porto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Metabolic Disease, Photoaging
Keywords
shock wave therapy, radiofrequency, adipose tissue, skin flaccidity, aerobic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
shockwave therapy group
Arm Type
Experimental
Arm Description
This group performed aerobic exercise just after shock wave therapy in the abdominal region.
Arm Title
radiofrequency group
Arm Type
Experimental
Arm Description
This group performed aerobic exercise just after radiofrequency in the abdominal region.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
This group only performed aerobic exercise.
Intervention Type
Device
Intervention Name(s)
Radiofrequency
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Aerobic exercise
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Shock wave therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cutaneous abdominal tissue thickness
Description
Measurement of the cutaneous fold by ultrasonography
Time Frame
Baseline
Title
Cutaneous abdominal tissue thickness
Description
Measurement of the cutaneous fold by ultrasonography
Time Frame
3 weeks after
Title
Cutaneous abdominal tissue thickness
Description
Measurement of the cutaneous fold by ultrasonography
Time Frame
6 weeks after
Title
Subcutaneous abdominal tissue thickness
Description
Measurement of the subcutaneous adipose fold by ultrasonography
Time Frame
Baseline
Title
Subcutaneous abdominal tissue thickness
Description
Measurement of the subcutaneous adipose fold by ultrasonography
Time Frame
3 weeks after
Title
Subcutaneous abdominal tissue thickness
Description
Measurement of the subcutaneous adipose fold by ultrasonography
Time Frame
6 weeks after
Title
Glycerol concentration
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
Baseline
Title
Glycerol concentration
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
3 weeks after
Title
Glycerol concentration
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
6 weeks after
Title
Lipid profile (LDL, HDL and triglyceride concentrations)
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
Baseline
Title
Lipid profile (LDL, HDL and triglyceride concentrations)
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
3 weeks after
Title
Lipid profile (LDL, HDL and triglyceride concentrations)
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
6 weeks after
Title
Perimetry
Description
Perimetry consists of measuring circumferences. In this case, of the waist at the navel area, 3 cm below it and in the hip area
Time Frame
Baseline
Title
Perimetry
Description
Perimetry consists of measuring circumferences. In this case, of the waist at the navel area, 3 cm below it and in the hip area
Time Frame
3 weeks after
Title
Perimetry
Description
Perimetry consists of measuring circumferences. In this case, of the waist at the navel area, 3 cm below it and in the hip area
Time Frame
6 weeks after
Title
Adipometry
Description
Adipometry consists of measuring skinfold thickness
Time Frame
Baseline
Title
Adipometry
Description
Adipometry consists of measuring skinfold thickness
Time Frame
3 weeks after
Title
Adipometry
Description
Adipometry consists of measuring skinfold thickness
Time Frame
6 weeks after
Title
Inflammatory markers concentration (IL6, CRP, TNF)
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
Baseline
Title
Inflammatory markers concentration (IL6, CRP, TNF)
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
3 weeks after
Title
Inflammatory markers concentration (IL6, CRP, TNF)
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
6 weeks after
Title
Nitrous oxide concentration
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
Baseline
Title
Nitrous oxide concentration
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
3 weeks after
Title
Nitrous oxide concentration
Description
Blood analysis collection carried out with help from an clinical analysis technician
Time Frame
6 weeks after
Title
Body composition- body mass
Description
body mass in kilograms
Time Frame
Baseline
Title
Body composition- body mass
Description
body mass in kilograms
Time Frame
3 weeks after
Title
Body composition- body mass
Description
body mass in kilograms
Time Frame
6 weeks after
Title
Body composition- muscle mass
Description
muscle mass in kilograms
Time Frame
Baseline
Title
Body composition- muscle mass
Description
muscle mass in kilograms
Time Frame
3 weeks after
Title
Body composition- muscle mass
Description
muscle mass in kilograms
Time Frame
6 weeks after
Title
Body composition- fat mass
Description
fat mass in kilograms
Time Frame
Baseline
Title
Body composition- fat mass
Description
fat mass in kilograms
Time Frame
3 weeks after
Title
Body composition- fat mass
Description
fat mass in kilograms
Time Frame
6 weeks after
Title
Body composition- visceral fat
Description
visceral fat
Time Frame
Baseline
Title
Body composition- visceral fat
Description
visceral fat
Time Frame
3 weeks after
Title
Body composition- visceral fat
Description
visceral fat
Time Frame
6 weeks after
Title
Body composition- fat body areas
Description
percentage of fat distributed by body areas
Time Frame
Baseline
Title
Body composition- fat body areas
Description
percentage of fat distributed by body areas
Time Frame
3 weeks after
Title
Body composition- fat body areas
Description
percentage of fat distributed by body areas
Time Frame
6 weeks after
Title
Thermography
Description
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
Time Frame
Baseline
Title
Thermography
Description
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
Time Frame
3 weeks after
Title
Thermography
Description
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
Time Frame
6 weeks after
Title
Photography
Description
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Time Frame
Baseline
Title
Photography
Description
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Time Frame
3 weeks after
Title
Photography
Description
Photography is used to compare the before and after images. With these it is possible to evaluate the skin flaccidity and fat
Time Frame
6 weeks after
Secondary Outcome Measure Information:
Title
skin flaccidity
Description
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)
Time Frame
Baseline
Title
skin flaccidity
Description
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)
Time Frame
3 weeks after
Title
skin flaccidity
Description
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)
Time Frame
6 weeks after
Title
skin flaccidity and localized fat in the abdomen region
Description
Satisfaction questionnaire to evaluate the final results according to the participant
Time Frame
Baseline
Title
skin flaccidity and localized fat in the abdomen region
Description
Satisfaction questionnaire to evaluate the final results according to the participant
Time Frame
3 weeks after
Title
skin flaccidity and localized fat in the abdomen region
Description
Satisfaction questionnaire to evaluate the final results according to the participant
Time Frame
6 weeks after

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Andreia Noites
City
Vila Nova de Gaia
State/Province
Porto
ZIP/Postal Code
4400-330
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21981441
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.
Results Reference
background
PubMed Identifier
28590827
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.
Results Reference
background
PubMed Identifier
31254455
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.
Results Reference
background
PubMed Identifier
31157522
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.
Results Reference
background

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Effects of Shockwave Therapy Versus Radiofrequency

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