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Shockwave Therapy (SWT) (SWT)

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ClinicalTrials.gov Identifier: NCT03986983
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gynoid Lipodystrophy Device: Shockwave therapy Other: Aerobic exercise Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : June 25, 2019
Estimated Primary Completion Date : July 26, 2019
Estimated Study Completion Date : July 26, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group of Aerobic exercise
The participants perform the Aerobic exercise protocol - The entire protocol was monitored through the Polar® brand heart rate monitor and watch.
Other: Aerobic exercise
Aerobic exercise protocol - 30 minutes of aerobic moderate-intensity exercise (40% of reserve heart rate) using Karvonen´s formula, performed on a step.

Experimental: Experimental group of Shockwave therapy and Aerobic Exercise

The participants do the Shockwave therapy protocol - The shockwave therapy protocol was performed in the prone position.

In addition, the participants also perform the Aerobic exercise protocol - The entire protocol was monitored through the Polar® brand heart rate monitor and watch.

Device: Shockwave therapy
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.

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

No Intervention: Control group
The participants do not perform any type of intervention.



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986983


Locations
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Portugal
Andreia Noites
Porto, Portugal, 4200-072
Sponsors and Collaborators
Escola Superior de Tecnologia da Saúde do Porto

Publications:

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Responsible Party: Andreia Noites, Investigator- Integrated Researcher, Center for Rehabilitation Research (CIR) School of Health of P.PORTO., Escola Superior de Tecnologia da Saúde do Porto
ClinicalTrials.gov Identifier: NCT03986983     History of Changes
Other Study ID Numbers: AN-008
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto:
Gynoid Lipodystrophy
Shock Wave Therapy
Aerobic Exercise

Additional relevant MeSH terms:
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Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases