Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02546778 |
| Other study ID # |
23686013.9.0000.5345 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
August 27, 2015 |
| Last updated |
September 9, 2015 |
| Start date |
May 2014 |
| Est. completion date |
August 2014 |
Study information
| Verified date |
September 2015 |
| Source |
Federal University of Health Science of Porto Alegre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Brazil: Ethics Committee |
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
