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Completed

NCT Number: NCT04282057

Effects of Shockwave Therapy Versus Radiofrequency

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.

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Key information

Conditions

Cardiovascular Risk Factor Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases Photoaging

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Andreia Noites

Vila Nova de Gaia, Porto District, 4400-330, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Radiofrequency

Device

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 exercise

Device

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 Therapy

Device

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 outcomes

  1. Cutaneous abdominal tissue thickness

    Time frame: Baseline

    Measurement of the cutaneous fold by ultrasonography

  2. Cutaneous abdominal tissue thickness

    Time frame: 3 weeks after

    Measurement of the cutaneous fold by ultrasonography

  3. Cutaneous abdominal tissue thickness

    Time frame: 6 weeks after

    Measurement of the cutaneous fold by ultrasonography

  4. Subcutaneous abdominal tissue thickness

    Time frame: Baseline

    Measurement of the subcutaneous adipose fold by ultrasonography

  5. Subcutaneous abdominal tissue thickness

    Time frame: 3 weeks after

    Measurement of the subcutaneous adipose fold by ultrasonography

  6. Subcutaneous abdominal tissue thickness

    Time frame: 6 weeks after

    Measurement of the subcutaneous adipose fold by ultrasonography

  7. Glycerol concentration

    Time frame: Baseline

    Blood analysis collection carried out with help from an clinical analysis technician

  8. Glycerol concentration

    Time frame: 3 weeks after

    Blood analysis collection carried out with help from an clinical analysis technician

  9. Glycerol concentration

    Time frame: 6 weeks after

    Blood analysis collection carried out with help from an clinical analysis technician

  10. Lipid profile (LDL, HDL and triglyceride concentrations)

    Time frame: Baseline

    Blood analysis collection carried out with help from an clinical analysis technician

  11. Lipid profile (LDL, HDL and triglyceride concentrations)

    Time frame: 3 weeks after

    Blood analysis collection carried out with help from an clinical analysis technician

  12. Lipid profile (LDL, HDL and triglyceride concentrations)

    Time frame: 6 weeks after

    Blood analysis collection carried out with help from an clinical analysis technician

  13. 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

  14. 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

  15. 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

  16. Adipometry

    Time frame: Baseline

    Adipometry consists of measuring skinfold thickness

  17. Adipometry

    Time frame: 3 weeks after

    Adipometry consists of measuring skinfold thickness

  18. Adipometry

    Time frame: 6 weeks after

    Adipometry consists of measuring skinfold thickness

  19. Inflammatory markers concentration (IL6, CRP, TNF)

    Time frame: Baseline

    Blood analysis collection carried out with help from an clinical analysis technician

  20. Inflammatory markers concentration (IL6, CRP, TNF)

    Time frame: 3 weeks after

    Blood analysis collection carried out with help from an clinical analysis technician

  21. Inflammatory markers concentration (IL6, CRP, TNF)

    Time frame: 6 weeks after

    Blood analysis collection carried out with help from an clinical analysis technician

  22. Nitrous oxide concentration

    Time frame: Baseline

    Blood analysis collection carried out with help from an clinical analysis technician

  23. Nitrous oxide concentration

    Time frame: 3 weeks after

    Blood analysis collection carried out with help from an clinical analysis technician

  24. Nitrous oxide concentration

    Time frame: 6 weeks after

    Blood analysis collection carried out with help from an clinical analysis technician

  25. Body composition- body mass

    Time frame: Baseline

    body mass in kilograms

  26. Body composition- body mass

    Time frame: 3 weeks after

    body mass in kilograms

  27. Body composition- body mass

    Time frame: 6 weeks after

    body mass in kilograms

  28. Body composition- muscle mass

    Time frame: Baseline

    muscle mass in kilograms

  29. Body composition- muscle mass

    Time frame: 3 weeks after

    muscle mass in kilograms

  30. Body composition- muscle mass

    Time frame: 6 weeks after

    muscle mass in kilograms

  31. Body composition- fat mass

    Time frame: Baseline

    fat mass in kilograms

  32. Body composition- fat mass

    Time frame: 3 weeks after

    fat mass in kilograms

  33. Body composition- fat mass

    Time frame: 6 weeks after

    fat mass in kilograms

  34. Body composition- visceral fat

    Time frame: Baseline

    visceral fat

  35. Body composition- visceral fat

    Time frame: 3 weeks after

    visceral fat

  36. Body composition- visceral fat

    Time frame: 6 weeks after

    visceral fat

  37. Body composition- fat body areas

    Time frame: Baseline

    percentage of fat distributed by body areas

  38. Body composition- fat body areas

    Time frame: 3 weeks after

    percentage of fat distributed by body areas

  39. Body composition- fat body areas

    Time frame: 6 weeks after

    percentage of fat distributed by body areas

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

Secondary outcomes

  1. skin flaccidity

    Time frame: 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)

  2. skin flaccidity

    Time frame: 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)

  3. skin flaccidity

    Time frame: 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)

  4. skin flaccidity and localized fat in the abdomen region

    Time frame: Baseline

    Satisfaction questionnaire to evaluate the final results according to the participant

  5. skin flaccidity and localized fat in the abdomen region

    Time frame: 3 weeks after

    Satisfaction questionnaire to evaluate the final results according to the participant

  6. skin flaccidity and localized fat in the abdomen region

    Time frame: 6 weeks after

    Satisfaction questionnaire to evaluate the final results according to the participant

Sponsors and collaborators

Lead sponsor

Escola Superior de Tecnologia da Saúde do Porto

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2020
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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