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Completed

NCT Number: NCT03986983

Shockwave Therapy (SWT)

The purpose of the present study is to evaluate the effects of six sessions of aerobic exercise associated with shock waves therapy in the severity of gynoid lipodystrophy.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Andreia Noites

Porto, 4200-072, Portugal

About this study

The Gynoid Lipodystrophy (GL) is considered to be a subcutaneous tissue disorder that causes changes in visible skin topography in the form of protrusions and depressions, mainly located in the lower limbs and abdominal region. It is a non-inflammatory and degenerative condition whose etiology has not been fully elucidated until now, although it can be explained by varied theories: the hormonal ,that is related to estrogen, the morphological one, based on alterations of the adipose tissue that is related to the interlobular septa of connective tissue that interconnects the subcutaneous adipose lobes, these septa are thin and have perpendicular projections, which favors the deposition of adipose tissue and its expansion to the surface of the dermis. The last one is about microcirculation deficits that can lead to intracellular edema and reduction of lymphatic drainage.

Shock wave therapy appears to be a safe and effective therapy to act in this disorder. It generates mechanical pressure waves in the tissues, promoting cavitation phenomena that produces lipolysis by destroying the cell membrane of adipocytes, increasing blood flow in the region, and stimulating lymphatic drainage.

On the other hand, there are studies that report that improvement in the appearance of GL is associated with a decrease in subcutaneous adipose tissue. Physiologically, aerobic physical exercise has the capacity to decrease body fat, taking into account that the oxidation reactions of fatty acids are enhanced, with moderate intensity exercise.

In this sense, it may be beneficial to associate Shockwave Therapy and Physical Exercise to reduce GL severity, so this study aims to analyze the effect of radial shock wave therapy in association with the performance of an aerobic exercise program, in female subjects, in the degree of GL severity in the gluteal region and ⅓ proximal posterior of the thighs.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants with a moderate and severe degree of cellulitis, according to an CSS, in the region of the buttocks and ⅓ proximal posterior of the thighs;

Exclusion criteria

  • Unstable weight during the last 6 months, with a variation of less than or equal to 2 kg has been initiated;
  • Hormonal treatment (contraceptive pill, intrauterine device, other) changed in the last 6 months;
  • Participants with food restrictions;
  • Pregnant women or post childbirth during the last year;

Treatment and study plan

Shockwave therapy

Device

Shockwave therapy protocol - The shockwave therapy protocol was performed in the prone position. The application was radial shockwave with 3,5bar, 15Hz of frequency and 3000 impulses.

Aerobic Exercise

Other

Aerobic exercise protocol - 30 minutes of aerobic moderate-intensity exercise (40% of reserve heart rate) using Karvonen´s formula, performed on a step.

Primary outcomes

  1. Change in the score of the Cellulite Severity Scale (CSS)

    Time frame: before the intervention program

    Verified by changes in the score of the CSS. The CSS is used to measure the severity of GL, this scale quantifies 5 variables such as the number of evident depressions, the depth of depressions , the morphological aspect of the skin surface, the degree of laxity, flaccidity, or sagging skin and the classification of GL using the scale of Nurnberger and Muller. Each variable can have a score of 0 to 3 and the final score is made by the total sum of these. The final score goes from 0 to 15 , which means that 0 to 5 is a mild degree of GL, 6 to 10 is moderate degree and 11 to 15 is considered a severe degree.

Secondary outcomes

  1. Subcutaneous buttock tissue thickness

    Time frame: before the intervention program

    Verified by changes in the measurement of the subcutaneous adipose fold by ultrasonography (mm)

  2. Changes in anthropometric measurements such as hip circumference, gluteal fold, and the proximal ⅓ of the thigh

    Time frame: before the intervention program

    Verified by changes in anthropometric measures such as hip circumference, gluteal fold, and the proximal ⅓ of the thigh before and after the intervention, evaluated using a tape measure (cm)

  3. Change in the microcirculation of the treatment area

    Time frame: before the intervention program

    Verified by changes in the thermography (ºC)

Sponsors and collaborators

Lead sponsor

Escola Superior de Tecnologia da Saúde do Porto

Other

Registry information

Official study title

Effect of Shockwave Therapy Associated With an Aerobic Exercise Program on the Degree of Severity of Gynoid Lipodystrophy in Women: a Randomized Controlled Trial

Acronym: SWT

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2019
Registry last updated
Dec 11, 2019

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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