Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Effects of Radiofrequency on Located Adiposity

9 settembre 2015 aggiornato da: Patricia Viana da Rosa, Federal University of Health Science of Porto Alegre

Effects of Radiofrequency on Located Adiposity: A Pilot Study

Nowadays increasingly quest for improved physical appearance, gradually developing the medicine of beauty, where the radio fits as an additional tool in helping some aging processes and maintenance of body shape. The aim of this study was to evaluate and compare the changes in the thickness of adipose tissue and blood levels of some biochemical markers of sedentary and active women who underwent radio frequency technique via ultrasound imaging and laboratory tests. Seven (7) sessions were held, each lasting 20 minutes each, 22 volunteers allocated into two groups, sedentary and physically active. Measures ultrasound image were collected at baseline, pre-treatment and post-treatment period period and serum biochemical parameters (lipid profile, liver and kidney) for the pre-treatment and post-treatment.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The demand for treatments for localized adiposity reduction increasingly gaining ground in beauty clinics due to the constant search for the perfect body and the current standards of beauty. The localized adiposity is characterized by a hypertrophy of unilocular fat cells that occurs in some parts of the body, especially the flanks and abdomen and often food programs combined with physical activity are not enough and requires a complementary treatment for redefinition of body shapes. The radio frequency is a non-invasive technique that emits electromagnetic waves generate heat in the skin layers. The technique is indicated for the treatment of edema fibro geloid (EGF), wrinkles, sagging and is also observed lipolytic effect acting directly at the level of accumulated fat cells helping to reduce the fat layer. With this vision, the investigators seek to evaluate the effects of Radio Frequency on localized f in patients who have this fat in the abdominal region, comparing a group of sedentary women with a group of women engaged in physical activities. Also will evaluate biochemical and anthropometric parameters so that they can provide indications about the effects of radio frequency in the human body.

This is a pilot study. The sample will consist of 30 females volunteers who participate, respecting the criteria for inclusion and exclusion previously cited by reading and signing the Informed Consent and Clarified.

The sample consists of 30 participants, divided into two groups, with 15 individuals will be regular exercise practitioners and 15 are sedentary, with participants from each group will undergo a 4-week control period between the first (base period) and second (pre-treatment) evaluations. Participants will be instructed to not change their respective routine activities.

For physical activity practitioner should perform at least 150 minutes of aerobic exercise of moderate intensity in the week, or at least 75 minutes of vigorous physical activity, or even that combine physical activity of moderate and vigorous intensity during the week. Both groups will make 12 sessions on individual radio frequency applications, twice a week, total of 6 weeks treatment.

To monitor the results, diagnostic ultrasound will be used to measure the fat layer. To collect the individual will be in the supine position with a pillow under the lumbar spine. The head will be positioned above the navel and the fat thickness is measured from the inner layer of the skin to the aponeurosis of the rectus abdominis muscle in the middle of the Alba line area. To measure the fatty layer of flanks the head that was in the umbilicus will be displaced laterally with the individual still in the supine position. The head is in the transverse plane will be asked to the individual who holds the air on exhalation to collect the image. The fat thickness measurements are made with a linear probe (7.5 MHz) with a depth of 4 to 5cm. The parameters used in this study have been previously tested and showed no health risk.

Among the methods used for assessing body composition, electrical bioimpedance has been widely used, especially by high speed in processing information, being a noninvasive method, practical, reproducible, which estimates, in addition to body components, the distribution of fluid in the intracellular and extracellular spaces, as well as the quality, size and cell integrity. For assessment of body composition, Bioelectrical impedance analysis (BIA) technique is based on the model of a cylindrical conductor with length and uniform and homogeneous cross-cutting area, to which the human body resembles. Evaluations shall be performed by a professional with training and experience in this type of analysis. For the examination, will be used Maltron BF-900 model unit and will be adopted the protocol recommendations proposed by the European Society for Clinical Nutrition and Metabolism:

  • Assess body mass and height of the individual at the time of examination;
  • Individual fasting and not drinking alcohol for at least 8 hours;
  • Urinate before the exam;
  • Do not perform physical exercise in the eight hours before the test;
  • No injury to the skin where the electrode will be;
  • Clean the skin with alcohol;
  • Position the electrodes always on the same side of the body;
  • Minimum of 5 cm distance between the electrodes;
  • Separated from the stem by arms 30 and legs apart by 45 °;
  • Environment should be neutral (no electric or magnetic field);
  • Notice the shape of the body to the risk of any possible anomaly (edema, amputation, atrophy, scoliosis, dystrophy);
  • In case of obesity, use of electricity insulating material (towel, for example) between the arm and torso, and between the thighs;
  • When prostheses or implants, to measure the opposite side;
  • Do not use metal objects in the examination as earrings, bracelets, watches and the like.

It is not indicated for individuals who have pacemaker and who are in pregnancy.

Anthropometric measurements will be measured by a previously trained evaluator. The height is determined by the balance rule coupled with a degree in 1 mm, with the individual back to this, in an upright standing position, feet together, and trying to put the posterior surface of heels, pelvic and shoulder girdle in contact with the instrument. Prior to the first session and after the last session will be measured body weight, skin suprailiac and abdominal folds, waist circumference, waist circumference, hip circumference and waist-hip ratio calculation.

Body weight will be measured through traditional mechanical scale with 100g graduation, with front man for the same, in the upright position, feet together, wearing light clothes and without shoes. Based on these two measurements will be done calculating the Body Mass Index, kg ÷ height x height.

The skinfold measure used to estimate the percentage of body fat will be taken using caliper. The supra-iliac and abdominal folds will be measured. The suprailiac preaches will be measured, taking as anatomical reference the iliac crest, in an oblique direction to the longitudinal axis of the body, plying middle region located between the last rib and the iliac crest on the medial axillary line. Since the abdominal crease is measured as taking anatomical reference umbilicus, plying up the region located 1 to 3 cm to the right of scar parallel to the longitudinal axis of the body.

The ratio of waist to hip index is the result of the equation that divides the circumference of the abdomen (cm) by hip circumference (cm). The measurement of waist circumference will be measured with the individual standing upright during the expiratory phase of respiration, using flexible measuring tape 1.5m, accurate to one decimal place, with ribbon positioned parallel to the floor, at least measured between the iliac crest and the last rib.

In Radio Frequency procedure will be used Dermosux RF equipment to decrease localized fat in the abdomen and flanks. The parameters are: maximum power of 50 Watts at a frequency of 1 MHz and will take place the measurement of skin temperature with a digital thermometer, keeping always between 40 - 42 ° C in the quadrants of the abdominal and flank region. The handle is used with continuous and repetitive movements with light pressure. A glycerin oil film over the treatment area as coupling means will be used.

The sessions will be held 2 times a week for six consecutive weeks. The time of each session will be around 40 minutes, and will be 10 minutes in the area for median-right and another 10 minutes in the area for median-left with the patient in the supine position. With the patient in the lateral decubitus will apply an additional 10 minutes on the right flank region and 10 minutes on the left flank region. The schedule of sessions will be marked in accordance with the provision of the sample. It will also be directed at the first session the importance of voluntary not change eating habits or daily lifestyle habits such as physical activity, smoking and alcohol.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

30

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 40 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Sedentary
  • physically active

Exclusion Criteria:

-

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Dermosux RF
The group received the radio frequency for 20 minutes with the frequency of 1 MHz with 40 W.
The radio frequency was used for 20 min in the abdomen and flanks, once per week for 7 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Use of radio frequency reduce the layer of fat in abdominal area
Lasso di tempo: 7 weeks
7 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Laura P Bem, Federal University of Health Science of Porto Alegre

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2014

Completamento primario (Effettivo)

1 maggio 2014

Completamento dello studio (Effettivo)

1 agosto 2014

Date di iscrizione allo studio

Primo inviato

27 agosto 2015

Primo inviato che soddisfa i criteri di controllo qualità

9 settembre 2015

Primo Inserito (Stima)

11 settembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 settembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 settembre 2015

Ultimo verificato

1 settembre 2015

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 23686013.9.0000.5345

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dermosux RF

Sottoscrivi