search
Back to results

Effect of Aerobic Exercise Associated With Abdominal Laser Therapy

Primary Purpose

Metabolic Disease

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low level laser therapy
Aerobic Exercise
Low level laser therapy without power
Sponsored by
Escola Superior de Tecnologia da Saúde do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Disease focused on measuring Aerobic Exercise, Lipolytic Laser, Lipid Profile, C-reactive protein, Lipolysis

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • age between 18 and 25 years.
  • BMI between 18,5Kg/m2 and 29,9Kg/m2
  • consider presenting abdominal fat

Exclusion Criteria:

  • pregnant or intending to be in a period of 9 months
  • 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

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Experimental group 1

    Experimental group 2

    Placebo group

    Arm Description

    This group performed aerobic exercise just after low level laser therapy in the abdominal region with eight electrodes distributed in line.

    This group performed aerobic exercise just after low level laser therapy in the abdominal region with eight electrodes distributed in line, but low level laser therapy device was switched off.

    Low level laser therapy without power. This group performed the low level laser therapy protocol, but low level laser therapy device was switched off.

    Outcomes

    Primary Outcome Measures

    Change in glycerol concentration
    Blood analysis collection was carried out with help from an clinical analysis technician.
    Change in CRP concentration
    Blood analysis collection was carried out with help from an clinical analysis technician.
    Change in lipid profile (LDL, HDL and triglyceride concentrations)
    Blood analysis collection was carried out with help from an clinical analysis technician.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 6, 2018
    Last Updated
    March 6, 2018
    Sponsor
    Escola Superior de Tecnologia da Saúde do Porto
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03462537
    Brief Title
    Effect of Aerobic Exercise Associated With Abdominal Laser Therapy
    Official Title
    Effect of Aerobic Exercise Associated With Abdominal Laser Therapy in Lipolytic Activity, Profile and Inflammatory Markers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Terminated
    Study Start Date
    November 20, 2016 (Actual)
    Primary Completion Date
    May 20, 2017 (Actual)
    Study Completion Date
    June 20, 2017 (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
    Product Manufactured in and Exported from the U.S.
    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 low level laser therapy in lipolytic activity, lipid profile and inflammatory markers (C-reactive protein - CRP).
    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 - low power laser therapy (LLLT) - on adipose tissue has been studied. This therapeutic modality stimulates cytochrome C oxidase, causing the release of nitric oxide, increased mitochondrial membrane potential and adenosine triphosphate (ATP) synthesis and the transient increase of reactive oxygen species (ROS). It is proposed that ROS creates temporary pores in the adipocyte membrane, allowing the release of its lipid content. It is also suggested that a regulation of cAMP occurs, which stimulates the lipolytic cascade, converting the triglycerides to fatty acids and glycerol. In this way, low level laser therapy seems to aid in the reduction of adiposity and in the decrease of cholesterol and triglycerides serum levels . 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. The application of low level laser therapy in the abdominal region enhances the release of fat acids and glycerol into the bloodstream, increasing the availability of the substrate for muscle energy consumption. However, if they are not used as energy, free circulating fat acids may bind to glycerol and potentiate, again, the accumulation of triglycerides in abdominal adipocytes. Thus, aerobic exercise seems to be a good option in the fight against this re-esterification, since it is expected that the resulting fat acids will be converted to acetyl-CoA, entering the Krebs cycle, being used as energy source during aerobic exercise.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Disease
    Keywords
    Aerobic Exercise, Lipolytic Laser, Lipid Profile, C-reactive protein, Lipolysis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group 1
    Arm Type
    Experimental
    Arm Description
    This group performed aerobic exercise just after low level laser therapy in the abdominal region with eight electrodes distributed in line.
    Arm Title
    Experimental group 2
    Arm Type
    Experimental
    Arm Description
    This group performed aerobic exercise just after low level laser therapy in the abdominal region with eight electrodes distributed in line, but low level laser therapy device was switched off.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Low level laser therapy without power. This group performed the low level laser therapy protocol, but low level laser therapy device was switched off.
    Intervention Type
    Device
    Intervention Name(s)
    Low level laser therapy
    Intervention Description
    Low level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes.
    Intervention Type
    Device
    Intervention Name(s)
    Aerobic Exercise
    Intervention Description
    Aerobic exercise protocol - 50 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 45 minutes); and cooling (from 45 to 50 minutes). The entire protocol was monitored through the Polar® brand cardiofrequency and watch.
    Intervention Type
    Device
    Intervention Name(s)
    Low level laser therapy without power
    Intervention Description
    Low level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes. In this group low level laser therapy device was switched off.
    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
    Change in CRP 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
    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
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age between 18 and 25 years. BMI between 18,5Kg/m2 and 29,9Kg/m2 consider presenting abdominal fat Exclusion Criteria: pregnant or intending to be in a period of 9 months 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25283463
    Citation
    Afrooz PN, Pozner JN, DiBernardo BE. Noninvasive and minimally invasive techniques in body contouring. Clin Plast Surg. 2014 Oct;41(4):789-804. doi: 10.1016/j.cps.2014.07.006.
    Results Reference
    background
    PubMed Identifier
    20025992
    Citation
    Ahmadian M, Wang Y, Sul HS. Lipolysis in adipocytes. Int J Biochem Cell Biol. 2010 May;42(5):555-9. doi: 10.1016/j.biocel.2009.12.009. Epub 2009 Dec 16.
    Results Reference
    background
    Citation
    Aquino Junior, A. E. (2012). Efeito do laser de baixa intensidade (830nm) associado ao exercício em ratos obesos exógenos. São Carlos: Universidade Federal de São Carlos
    Results Reference
    background
    PubMed Identifier
    26026683
    Citation
    Aquino AE Jr, Sene-Fiorese M, Castro CA, Duarte FO, Oishi JC, Santos GC, Silva KA, Fabrizzi F, Moraes G, Matheus SM, Duarte AC, Bagnato VS, Parizotto NA. Can low-level laser therapy when associated to exercise decrease adipocyte area? J Photochem Photobiol B. 2015 Aug;149:21-6. doi: 10.1016/j.jphotobiol.2015.04.033. Epub 2015 May 20.
    Results Reference
    background
    PubMed Identifier
    24049929
    Citation
    Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg. 2013 Mar;32(1):41-52.
    Results Reference
    background
    PubMed Identifier
    23749426
    Citation
    Avci P, Nyame TT, Gupta GK, Sadasivam M, Hamblin MR. Low-level laser therapy for fat layer reduction: a comprehensive review. Lasers Surg Med. 2013 Aug;45(6):349-57. doi: 10.1002/lsm.22153. Epub 2013 Jun 7.
    Results Reference
    background
    PubMed Identifier
    15114147
    Citation
    Brown SA, Rohrich RJ, Kenkel J, Young VL, Hoopman J, Coimbra M. Effect of low-level laser therapy on abdominal adipocytes before lipoplasty procedures. Plast Reconstr Surg. 2004 May;113(6):1796-804; discussion 1805-6. doi: 10.1097/01.prs.0000117302.73214.1a.
    Results Reference
    background
    PubMed Identifier
    25958170
    Citation
    da Silveira Campos RM, Damaso AR, Masquio DC, Aquino AE Jr, Sene-Fiorese M, Duarte FO, Tock L, Parizotto NA, Bagnato VS. Low-level laser therapy (LLLT) associated with aerobic plus resistance training to improve inflammatory biomarkers in obese adults. Lasers Med Sci. 2015 Jul;30(5):1553-63. doi: 10.1007/s10103-015-1759-9. Epub 2015 May 10.
    Results Reference
    background
    Citation
    Cavalheiro, C., Ferreira, A., & Assunção, F. (2012). O uso da eletrolipólise no tratamento da adiposidade localizada. Revisão integrativa. Ensaios e Ciência: Ciências Biológicas, Agrárias e da Saúde, 16(3), 157-165.
    Results Reference
    background
    Citation
    Costa, A., Eberlin, S., Jorge, A., Mendonça, J., Kalies, A., & Pereira, C. (2014). Clinical study to assess abdominal circumferential reduction after treatment with lowfrequency. Surgical And Cosmetic Dermatology, 6(4), 320-324.
    Results Reference
    background
    PubMed Identifier
    20083961
    Citation
    Donges CE, Duffield R, Drinkwater EJ. Effects of resistance or aerobic exercise training on interleukin-6, C-reactive protein, and body composition. Med Sci Sports Exerc. 2010 Feb;42(2):304-13. doi: 10.1249/MSS.0b013e3181b117ca.
    Results Reference
    background
    PubMed Identifier
    21384392
    Citation
    Elm CM, Wallander ID, Endrizzi B, Zelickson BD. Efficacy of a multiple diode laser system for body contouring. Lasers Surg Med. 2011 Feb;43(2):114-21. doi: 10.1002/lsm.21016. Erratum In: Lasers Surg Med. 2011 Sep;43(7):781-2.
    Results Reference
    background
    PubMed Identifier
    18436717
    Citation
    de Ferranti S, Mozaffarian D. The perfect storm: obesity, adipocyte dysfunction, and metabolic consequences. Clin Chem. 2008 Jun;54(6):945-55. doi: 10.1373/clinchem.2007.100156. Epub 2008 Apr 24.
    Results Reference
    background
    Citation
    Glisezinski, & I. (2007). Mobilisation des lipides du tissu adipeux au cours de l'exercice physique. Science & Sports, 22(6), 280-285. doi:10.1016/j.scispo.2007.09.013
    Results Reference
    background
    PubMed Identifier
    14516937
    Citation
    Horowitz JF. Fatty acid mobilization from adipose tissue during exercise. Trends Endocrinol Metab. 2003 Oct;14(8):386-92. doi: 10.1016/s1043-2760(03)00143-7.
    Results Reference
    background
    Citation
    Jackson, R. F., Roche, G. C., & Wisler, K. (2010). Reduction in Cholesterol and Triglyceride Serum Levels Following Low-Level Laser Irradiation: A Noncontrolled, Nonrandomized Pilot Study. The American Journal of Cosmetic Surgery, 27, 177-184.
    Results Reference
    background
    PubMed Identifier
    2651364
    Citation
    Karu T. Photobiology of low-power laser effects. Health Phys. 1989 May;56(5):691-704. doi: 10.1097/00004032-198905000-00015.
    Results Reference
    background
    PubMed Identifier
    7670387
    Citation
    Karu TI, Afanas'eva NI. [Cytochrome c oxidase as the primary photoacceptor upon laser exposure of cultured cells to visible and near IR-range light]. Dokl Akad Nauk. 1995 Jun;342(5):693-5. No abstract available. Russian.
    Results Reference
    background
    PubMed Identifier
    18651871
    Citation
    Karu TI. Mitochondrial signaling in mammalian cells activated by red and near-IR radiation. Photochem Photobiol. 2008 Sep-Oct;84(5):1091-9. doi: 10.1111/j.1751-1097.2008.00394.x. Epub 2008 Jul 18.
    Results Reference
    background
    PubMed Identifier
    25664493
    Citation
    Kennedy J, Verne S, Griffith R, Falto-Aizpurua L, Nouri K. Non-invasive subcutaneous fat reduction: a review. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1679-88. doi: 10.1111/jdv.12994. Epub 2015 Feb 9.
    Results Reference
    background
    PubMed Identifier
    19464318
    Citation
    Lafontan M, Langin D. Lipolysis and lipid mobilization in human adipose tissue. Prog Lipid Res. 2009 Sep;48(5):275-97. doi: 10.1016/j.plipres.2009.05.001. Epub 2009 May 21.
    Results Reference
    background
    PubMed Identifier
    21824546
    Citation
    Mulholland RS, Paul MD, Chalfoun C. Noninvasive body contouring with radiofrequency, ultrasound, cryolipolysis, and low-level laser therapy. Clin Plast Surg. 2011 Jul;38(3):503-20, vii-iii. doi: 10.1016/j.cps.2011.05.002.
    Results Reference
    background
    PubMed Identifier
    12172159
    Citation
    Neira R, Arroyave J, Ramirez H, Ortiz CL, Solarte E, Sequeda F, Gutierrez MI. Fat liquefaction: effect of low-level laser energy on adipose tissue. Plast Reconstr Surg. 2002 Sep 1;110(3):912-22; discussion 923-5. doi: 10.1097/00006534-200209010-00030.
    Results Reference
    background
    PubMed Identifier
    22468172
    Citation
    Nestor MS, Zarraga MB, Park H. Effect of 635nm Low-level Laser Therapy on Upper Arm Circumference Reduction: A Double-blind, Randomized, Sham-controlled Trial. J Clin Aesthet Dermatol. 2012 Feb;5(2):42-8.
    Results Reference
    background
    Citation
    Powers, S. K., & Howley, E. T. (2004). Fisiologia do Exercício - Teoria e Aplicação ao Condicionamento e ao Desempenho (5ª ed.). Brasil: Manole.
    Results Reference
    background
    PubMed Identifier
    9623840
    Citation
    Rosenbaum M, Prieto V, Hellmer J, Boschmann M, Krueger J, Leibel RL, Ship AG. An exploratory investigation of the morphology and biochemistry of cellulite. Plast Reconstr Surg. 1998 Jun;101(7):1934-9. doi: 10.1097/00006534-199806000-00025.
    Results Reference
    background
    PubMed Identifier
    17909397
    Citation
    Stewart LK, Flynn MG, Campbell WW, Craig BA, Robinson JP, Timmerman KL, McFarlin BK, Coen PM, Talbert E. The influence of exercise training on inflammatory cytokines and C-reactive protein. Med Sci Sports Exerc. 2007 Oct;39(10):1714-9. doi: 10.1249/mss.0b013e31811ece1c.
    Results Reference
    background
    PubMed Identifier
    18665762
    Citation
    Tafur J, Mills PJ. Low-intensity light therapy: exploring the role of redox mechanisms. Photomed Laser Surg. 2008 Aug;26(4):323-8. doi: 10.1089/pho.2007.2184.
    Results Reference
    background

    Learn more about this trial

    Effect of Aerobic Exercise Associated With Abdominal Laser Therapy

    We'll reach out to this number within 24 hrs