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Trial record 2 of 156 for:    Modulated Light Therapy | Completed Studies

Effects of Phototherapy Associated With Sprint and Squat Training on Cardiac Autonomic Modulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03566186
Recruitment Status : Completed
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Franciele Marques Vanderle, Paulista University

Brief Summary:
Recent studies have shown positive results in the application of phototherapy for the improvement of performance and acceleration of the healing process of the body homeostasis. Among the methods used to assess the recovery post-exercise has cardiac autonomic modulation assessed by heart rate variability (HRV), a tool widely used in sports to evaluate medium global behavior of the autonomic nervous system. Objective: analyze and compare the effect of a special protocol of phototherapy using different light sources interacting with a combined training with an autonomic modulation of heart rate in different moments (baseline; tracking daily; recovery post-exercise and after training). Method: 45 male participants will be allocated from a stratified randomization into three groups: control (n=15), placebo (n=15) and group special protocol of phototherapy (n=15). Participants will perform a combined training of sprints and squats twice a week for twelve weeks divided into two phases. The application of phototherapy and placebo was administered in phase 2, after sprints and just before the squat. The phototherapy was used combine different light sources and wavelength (red and infrared). Was analyze HRV in five moments: baseline; traking daily; week target of phase I and II; after training. The weeks target consist of training sessions with greater energy expenditure (largest intensity). The sphericity of the data was tested by Mauchly test. In case of violation of the sphericity assumption, the correction of Greenhouse-Geisser was performed. The data was analyzed using analysis of variance for repeated measures (Bonferroni post-test), which provide information on the effects of time, group and interaction. All statistical analyzes assume the significance level of 5%.

Condition or disease Intervention/treatment Phase
Phototherapy Autonomic Nervous System Training Other: Phototherapy Other: Placebo Other: Passive recovery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Phototherapy Associated With Sprint and Squat Training on Cardiac Autonomic Modulation: Randomized, Placebo-controlled Trial
Actual Study Start Date : September 3, 2017
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : December 19, 2017

Arm Intervention/treatment
Experimental: Active phototherapy group
(n=12) Phase 2 training + active phototherapy Dosage applied was 30J per site (180J per muscle) to six sites on the quadriceps The MR4 LaserShower 50 4D emitter (MultiRadiance Medical, USA). The optical power was calibrated before irradiationin each participant using a Thorlabs thermal power meter(Model S322C, Thorlabs, Newton, NJ, USA).
Other: Phototherapy
Photobiomodulation or photobiostimulation, this technique is the application of monochromatic light that can influence cellular activity through inhibition or stimulation of chemical and biological functions.

Placebo Comparator: Placebo group
(n=14) Phase 2 training + placebo phototherapy group
Other: Placebo
The same procedures as in the active phototherapy group was applied to the placebo group; however, the emitter was disabled. The device was emit the same sounds regardless of the programmed mode (active phototherapy).

non-treatment control group
(n=13) Phase 2 training + control group
Other: Passive recovery
Participants was remain sat for passive recovery supervised by an independent therapist during the period when the other groups are received recovery strategies.




Primary Outcome Measures :
  1. Effects of phototherapy on adaptation and change of cardiac Autonomic modulation. [ Time Frame: Baseline (captation of hear rate variability for 20 minutes) before 6 weeks (captation of hear rate variability for 20 minutes) and before 12 weeks (captation of hear rate variability for 20 minutes) ]
    Analyzed and compare the effects of phototherapy with different light sources and wavelengths applied during training combined at heart rate variability


Secondary Outcome Measures :
  1. Effects of phototherapy on recovery of cardiac Autonomic modulation. [ Time Frame: During training sessions with higher energetic spending leaving for the last two weeks, composed of higher intensity - (captation of hear rate variability for 1 hour on phase 1 and phase 2). ]
    Compare the effects of phototherapy with placebo group and control group at recovery after exercise of heart rate variability.

  2. Effects of phototherapy on tracking daily of cardiac autonomic modulation. [ Time Frame: daily, after exercise and before exercise (captation of hear rate variability for 7 minutes) ]
    Analyze and compare the change in the indices of heart rate variability in tracking daily after combined training of sprints and squats



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy patient (self-report);
  • Male gender;

Exclusion Criteria:

  • History of cancer;
  • Smokers or alcoholics;
  • Use drugs that influenced cardiac autonomic activity;
  • Cardiovascular, metabolic or endocrine diseases;
  • Occurrence of musculoskeletal injury during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566186


Locations
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Brazil
Franciele Marques Vanderlei
Presidente Prudente, SP, Brazil, 55
Sponsors and Collaborators
Paulista University
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Responsible Party: Franciele Marques Vanderle, PhD - Clinical Professor, Paulista University
ClinicalTrials.gov Identifier: NCT03566186    
Other Study ID Numbers: U1111-1214-0497
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franciele Marques Vanderle, Paulista University:
Photobiomodulation
Autonomic nervous system
Heart rate variability
Recovery of function
Super-pulsed laser
Led light