Combination of Light and Ultrasound to Reduce Abdominal Fat

NCT05155683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2023-12-12

No results posted yet for this study

Summary

Light and ultrasound can be interesting alternatives to reduce abdominal fat. Thus, the main objective of this study will be to evaluate the effects of these isolated techniques and their association in subcutaneous abdominal localized fat. These techniques will be used adding muscle electrostimulation in all groups. A total of 40 female participants will be recruited at the university outpatient, which will be distributed among four experimental groups: light + sham ultrasound + electrostimulation; light sham + ultrasound + electrostimulation; combined treatment (light + ultrasound) + electrostimulation; sham combined treatment + electrostimulation. The treatments will consist of eight sessions, twice a week for a month, being 90 minutes per session.

Conditions

  • Subcutaneous Fat Disorder

Interventions

DEVICE

Photobiomodulation (PBM) with infrared LED

All participants will receive 30 minutes of PBM (or PBM sham), with an abdominal strap containing 4 LED clusters with 72 devices that emit 830 nm wavelength with 20 nm spectral width, in continuous operating mode, 5 mW average radiant power per LED, 71 mW/cm² power density at aperture, 20.4 cm² of total area irradiated, 71 mW/cm² of irradiance at target, exposure duration of 1800 seconds, 127.8 J/cm² of radiant exposure, 2.6 kJ of radiant energy, per contact application technique, twice a week for a month, totaling 8 sessions.

DEVICE

Low-frequency ultrasound (LOFU)

Subsequently the demarcation of the target area for LOFU treatment (Thoor DGM Electronica, Santo André, São Paulo, Brazil), the application of the neutral conductive gel will occur for the use of low-frequency ultrasound for 30 minutes, which will occur with 22 cm² effective radiating area (ERA) size, \<8 BNR emission intensity, 40 kHz frequency, continuous mode, 60W, 100 cm² of total treated area, twice a week for a month, totaling 8 sessions.

DEVICE

Muscle electrostimulation

The session will end with 20 minutes of Russian Current (Tensor DGM Electronica, Santo André, São Paulo, Brazil), whose carrier frequency occurs in 2500 Hz, which will be adjusted according to the parameters described by Evangelista et al. (2003), which are: pulse frequency of 30 Hz; up/down ramp of 2 seconds each; support/rest time of 13 seconds each. The current intensity used will be the maximum supported by each participant and that is comfortable and sufficient to provide visible contraction. The treatment will consist of eight sessions that will occur twice a week, totaling a month of treatment.

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Principal Investigators

  • Michelle M Sena, MSc · PhD student

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-05-30
Completion
2023-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05155683 on ClinicalTrials.gov