Effect of Aerobic Exercise Associated With Abdominal Radiofrequency on on Adipose Tissue in Women:
Primary Purpose
Cardiovascular Risk Factor, Metabolic Disease
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Radiofrequency
Radiofrequency without power
Aerobic exercise
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Risk Factor
Eligibility Criteria
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
Sites / Locations
- Andreia Noites
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Placebo group
Arm Description
This group performed aerobic exercise just after radiofrequency therapy in the abdominal region.
This group performed aerobic exercise just after radiofrequency therapy in the abdominal region but the radiofrequency device was switched off- Radiofrequency without power.
Outcomes
Primary Outcome Measures
Change in glycerol concentration
Blood analysis collection was carried out with help from an clinical analysis technician.
Subcutaneous abdominal tissue thickness
Measurement of the subcutaneous adipose fold by ultrasonography
Secondary Outcome Measures
Change in lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection was carried out with help from an clinical analysis technician.
Full Information
NCT ID
NCT03594812
First Posted
July 4, 2018
Last Updated
January 29, 2019
Sponsor
Escola Superior de Tecnologia da Saúde do Porto
1. Study Identification
Unique Protocol Identification Number
NCT03594812
Brief Title
Effect of Aerobic Exercise Associated With Abdominal Radiofrequency on on Adipose Tissue in Women:
Official Title
Effect of Aerobic Exercise Associated With Abdominal Radiofrequency on on Adipose Tissue in Women: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Tecnologia da Saúde do Porto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Metabolic Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
This group performed aerobic exercise just after radiofrequency therapy in the abdominal region.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group performed aerobic exercise just after radiofrequency therapy in the abdominal region but the radiofrequency device was switched off- Radiofrequency without power.
Intervention Type
Device
Intervention Name(s)
Radiofrequency
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Radiofrequency without power
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Aerobic exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in glycerol concentration
Description
Blood analysis collection was carried out with help from an clinical analysis technician.
Time Frame
10 minutes before the intervention and 5 minutes after the intervention
Title
Subcutaneous abdominal tissue thickness
Description
Measurement of the subcutaneous adipose fold by ultrasonography
Time Frame
before intervention and 2 week after (after 4 sessions of intervention )
Secondary Outcome Measure Information:
Title
Change in lipid profile (LDL, HDL and triglyceride concentrations)
Description
Blood analysis collection was carried out with help from an clinical analysis technician.
Time Frame
10 minutes before the intervention and 5 minutes after the intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Andreia Noites
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
12. IPD Sharing Statement
Citations:
PubMed Identifier
20395192
Citation
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.
Results Reference
result
PubMed Identifier
22382873
Citation
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.
Results Reference
result
PubMed Identifier
18093200
Citation
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.
Results Reference
result
PubMed Identifier
28095578
Citation
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.
Results Reference
result
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