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Shockwave Therapy (SWT)

NCT ID: NCT03986983

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-25

Study Completion Date

2019-07-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gynoid Lipodystrophy

Keywords

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Gynoid Lipodystrophy Shock Wave Therapy Aerobic Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Shockwave therapy

Intervention Type 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

Intervention Type OTHER

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

Control group

The participants do not perform any type of intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Escola Superior de Tecnologia da Saúde do Porto

OTHER

Sponsor Role lead

Responsible Party

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Andreia Noites

Investigator- Integrated Researcher, Center for Rehabilitation Research (CIR) School of Health of P.PORTO.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Andreia Noites

Porto, , Portugal

Site Status

Countries

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Portugal

References

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Adatto M, Adatto-Neilson R, Servant JJ, Vester J, Novak P, Krotz A. Controlled, randomized study evaluating the effects of treating cellulite with AWT/EPAT. J Cosmet Laser Ther. 2010 Aug;12(4):176-82. doi: 10.3109/14764172.2010.500392.

Reference Type BACKGROUND
PMID: 20590369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21981441 (View on PubMed)

Christ C, Brenke R, Sattler G, Siems W, Novak P, Daser A. Improvement in skin elasticity in the treatment of cellulite and connective tissue weakness by means of extracorporeal pulse activation therapy. Aesthet Surg J. 2008 Sep-Oct;28(5):538-44. doi: 10.1016/j.asj.2008.07.011.

Reference Type BACKGROUND
PMID: 19083577 (View on PubMed)

Hexsel D, Camozzato FO, Silva AF, Siega C. Acoustic wave therapy for cellulite, body shaping and fat reduction. J Cosmet Laser Ther. 2017 Jun;19(3):165-173. doi: 10.1080/14764172.2016.1269928. Epub 2017 Feb 2.

Reference Type BACKGROUND
PMID: 27997260 (View on PubMed)

Knobloch K, Joest B, Kramer R, Vogt PM. Cellulite and focused extracorporeal shockwave therapy for non-invasive body contouring: a randomized trial. Dermatol Ther (Heidelb). 2013 Dec;3(2):143-55. doi: 10.1007/s13555-013-0039-5. Epub 2013 Dec 3.

Reference Type BACKGROUND
PMID: 24297647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28590827 (View on PubMed)

Perez Atamoros FM, Alcala Perez D, Asz Sigall D, Avila Romay AA, Barba Gastelum JA, de la Pena Salcedo JA, Escalante Salgado PE, Gallardo Palacios GJ, Guerrero-Gonzalez GA, Morales De la Cerda R, Ponce Olivera RM, Rossano Soriano F, Solis Tinoco E, Welsh Hernandez EC. Evidence-based treatment for gynoid lipodystrophy: A review of the recent literature. J Cosmet Dermatol. 2018 Dec;17(6):977-983. doi: 10.1111/jocd.12555. Epub 2018 Apr 30.

Reference Type BACKGROUND
PMID: 29707877 (View on PubMed)

Other Identifiers

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AN-008

Identifier Type: -

Identifier Source: org_study_id