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

January 29, 2019 updated by: Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The adipose tissue is the main energetic reserve, being constituted by adipocytes, cells that accumulate lipids inside its cytoplasm, in the form of triglycerides.

Fat deposition can occur both in the subcutaneous compartment and in the visceral compartment and is the result of a positive energy balance in which there is an imbalance between the amount of calories consumed and the amount of calories expended. Thus, an excess of energy storage occurs in the form of triglycerides in adipose tissue, which results from a sedentary lifestyle and a diet based on lipid rich nutrients. When fat deposition occurs in abdominal adipose tissue may favor the development of metabolic disorders.

Recently the effectiveness of an innovative physiotherapeutic intervention - radiofrequency on adipose tissue has been studied. This therapeutic modality stimulates the lipolytic cascade, converting the triglycerides to fatty acids and glycerol. In this way, radiofrequency seems to aid in the reduction of adiposity. In addition, it assists in the reduction of the inflammatory process related to obesity, by reducing the pro-inflammatory cytokines.

The aerobic exercise, due to its low-moderate intensity, enhances the stimulation of lipolysis, by decreasing plasma insulin concentration and elevating the level of catecholamines. In this way, it influences the lipid metabolism, seeming to improve the lipid profile, through the degradation of the triglycerides as energetic substrate. In addition, the regular practice of physical exercise seems to promote a decrease in the inflammation state due to metabolic changes, through the reduction of pro-inflammatory cytokines, namely interleukin-6 and, consequently, C-reactive protein.

This study purpose understanding whether an aerobic exercise session associated with abdominal radiofrequency increases the level of lipolytic activity; To analyse the effect of four intervention sessions on abdominal adipose tissue

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4200-072
        • Andreia Noites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
This group performed aerobic exercise just after radiofrequency therapy in the abdominal region.
Device: Radiofrequency
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.
Device: Aerobic exercise
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.
Placebo Comparator: Placebo group
This group performed aerobic exercise just after radiofrequency therapy in the abdominal region but the radiofrequency device was switched off- Radiofrequency without power.
Device: Aerobic exercise
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.
Device: Radiofrequency without power
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in glycerol concentration
Time Frame: 10 minutes before the intervention and 5 minutes after the intervention
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
Time Frame: before intervention and 2 week after (after 4 sessions of intervention )
Measurement of the subcutaneous adipose fold by ultrasonography
before intervention and 2 week after (after 4 sessions of intervention )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lipid profile (LDL, HDL and triglyceride concentrations)
Time Frame: 10 minutes before the intervention and 5 minutes after the intervention
Blood analysis collection was carried out with help from an clinical analysis technician.
10 minutes before the intervention and 5 minutes after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escola Superior de Tecnologia da Saúde do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2018

Primary Completion (Actual)

August 20, 2018

Study Completion (Actual)

September 20, 2018

Study Registration Dates

First Submitted

July 4, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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