Cardiovascular Risk FactorNCT03594812
Effect of Aerobic Exercise Associated With Abdominal Radiofrequency on on Adipose Tissue in Women:
A study testing Radiofrequency, Radiofrequency without power and Aerobic exercise in people with Cardiovascular Risk Factor and Metabolic Disease, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Metabolic Disease
- What is being tested?
- Radiofrequency, Radiofrequency without power and Aerobic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Jul 2018to 20 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Idex between 18,5 Kg/cm2 and 29,9 Kg/cm2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Cardiovascular Risk Factor, Metabolic Disease
- Being tested
- Radiofrequency, Radiofrequency without power, Aerobic exercise
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyDevice
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.
Radiofrequency without powerDevice
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.
Aerobic exerciseDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | This group performed aerobic exercise just after radiofrequency therapy in the abdominal region. Receives: 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. Receives: Device: Radiofrequency without power; Device: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycerol concentration
Blood analysis collection was carried out with help from an clinical analysis technician.
Measured: 10 minutes before the intervention and 5 minutes after the intervention
Subcutaneous abdominal tissue thickness
Measurement of the subcutaneous adipose fold by ultrasonography
Measured: before intervention and 2 week after (after 4 sessions of intervention )
Secondary outcomes (1)
Change in lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection was carried out with help from an clinical analysis technician.
Measured: 10 minutes before the intervention and 5 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start15 Jul 2018
- Primary completion20 Aug 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594812
- Sponsor's protocol ID
- AN-007
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20395192Belenky 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.
PubMed 22382873Goldberg 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.
PubMed 18093200Hayre 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.
PubMed 28095578
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise Associated With Abdominal Radiofrequency on on Adipose Tissue in Women: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03594812
- Acronym / sponsor ID
- AN-007
- Conditions
- Cardiovascular Risk Factor, Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Radiofrequency, Device: Aerobic exerciseThis group performed aerobic exercise just after radiofrequency therapy in the abdominal region. |
| Placebo group | Placebo comparator | Device: Radiofrequency without power, Device: Aerobic exerciseThis group performed aerobic exercise just after radiofrequency therapy in the abdominal region but the radiofrequency device was switched off- Radiofrequency without power. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Idex between 18,5 Kg/cm2 and 29,9 Kg/cm2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiofrequencyRadiofrequency 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 | Experimental group |
| Radiofrequency without powerRadiofrequency 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. | Device | Placebo group |
| Aerobic exerciseAerobic 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 | Experimental group, Placebo group |
Primary outcome
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.
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
1 secondary outcome
Change in lipid profile (LDL, HDL and triglyceride concentrations)
Time frame: 10 minutes before the intervention and 5 minutes after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Results publication: PubMed 20395192Boisnic 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 publication: PubMed 22382873Belenky 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 publication: PubMed 18093200Goldberg 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 publication: PubMed 28095578Hayre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency, Radiofrequency without power and Aerobic exercise in people with Cardiovascular Risk Factor and Metabolic Disease, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycerol concentration (time frame: 10 minutes before the intervention and 5 minutes after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03594812, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.