Effect of Aerobic Exercise Associated With Abdominal Radiofrequency on on Adipose Tissue in Women:

NCT03594812 | Completed DMC

• 1 other identifier: AN-007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study was to evaluate the effects of one session of aerobic exercise associated with radiofrequency in lipolytic activity and lipid profile.

Conditions

Cardiovascular Risk Factor; Metabolic Disease

Outcome Measures

Primary Outcomes (2)

• Change in glycerol concentration

  Blood analysis collection was carried out with help from an clinical analysis technician.

  10 minutes before the intervention and 5 minutes after the intervention

• Subcutaneous abdominal tissue thickness

  Measurement of the subcutaneous adipose fold by ultrasonography

  before intervention and 2 week after (after 4 sessions of intervention )

Secondary Outcomes (1)

• Change in lipid profile (LDL, HDL and triglyceride concentrations)

  10 minutes before the intervention and 5 minutes after the intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

This group performed aerobic exercise just after radiofrequency therapy in the abdominal region.

Device: Radiofrequency; Device: Aerobic exercise

Placebo group

PLACEBO COMPARATOR

This group performed aerobic exercise just after radiofrequency therapy in the abdominal region but the radiofrequency device was switched off- Radiofrequency without power.

Device: Radiofrequency without power; Device: Aerobic exercise

Interventions

Radiofrequency DEVICE

Radiofrequency protocol - The radiofrequency protocol was performed in dorsal decubitus, with the head elevated at 45º. The application was in capacitive mode, with a 5 cm electrode, always in movement. The duration of the application was established in 20 minutes, maintaining the local temperature between 40ºC to 42 ºC at the epidermis.

Experimental group

Radiofrequency without power DEVICE

Radiofrequency protocol - The radiofrequency protocol was performed in dorsal decubitus, with the head elevated at 45ºC (Celsius degrees). The application was in capacitive mode, with a 5 cm electrode, always in movement. The duration of the application was established in 20 minutes, maintaining the local temperature between 40ºC to 42 ºC at the epidermis. In this group, the radiofrequency device was switched off.

Placebo group

Aerobic exercise DEVICE

Aerobic exercise protocol - 40 minutes of aerobic moderate-intensity exercise (45-55% of reserve heart rate) using Karvonen´s formula, performed on a cycloergometer. The duration of the exercise was divided into three parts: warm-up (from 0 to 5 minutes); body (from 5 to 35 minutes); and cooling (from 35 to 40 minutes). The entire protocol was monitored through the Polar® brand heart rate monitor and watch.

Experimental group; Placebo group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Idex between 18,5 Kg/cm2 and 29,9 Kg/cm2

You may not qualify if:

• pregnant or intending to be in a period of an year
• participants with smoking habits
• participants with neoplasias, metabolic dysfunctions, renal pathologies, dermatological alterations
• participants with electronic devices
• participants with a condition that makes it impossible to practice physical exercise (disabling skeletal muscle pathologies and severe cardiorespiratory pathologies) participants under the effect of beta-blockers or other drugs which influence heart rate participants submitted to other fat reduce procedure

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Andreia Noites

Porto, 4200-072, Portugal

Location

Related Publications (4)

• Boisnic S, Branchet MC, Birnstiel O, Beilin G. Clinical and histopathological study of the TriPollar home-use device for body treatments. Eur J Dermatol. 2010 May-Jun;20(3):367-72. doi: 10.1684/ejd.2010.0938. Epub 2010 Apr 16.

  PMID: 20395192 RESULT

• Belenky I, Margulis A, Elman M, Bar-Yosef U, Paun SD. Exploring channeling optimized radiofrequency energy: a review of radiofrequency history and applications in esthetic fields. Adv Ther. 2012 Mar;29(3):249-66. doi: 10.1007/s12325-012-0004-1. Epub 2012 Feb 29.

  PMID: 22382873 RESULT

• Goldberg DJ, Fazeli A, Berlin AL. Clinical, laboratory, and MRI analysis of cellulite treatment with a unipolar radiofrequency device. Dermatol Surg. 2008 Feb;34(2):204-9; discussion 209. doi: 10.1111/j.1524-4725.2007.34038.x. Epub 2007 Dec 17.

  PMID: 18093200 RESULT

• Hayre N, Palm M, Jenkin P. A Clinical Evaluation of a Next Generation, Non-Invasive, Selective Radiofrequency, Hands-Free, Body-Shaping Device. J Drugs Dermatol. 2016 Dec 1;15(12):1557-1561.

  PMID: 28095578 RESULT

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 20, 2018
• Study Start: July 15, 2018
• Primary Completion: August 20, 2018
• Study Completion: September 20, 2018
• Last Updated: January 30, 2019

Record last verified: 2018-07

Locations

PT (1)