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

Sponsor

Paulista University (Other)

Overall Status

Completed

CT.gov ID

NCT03566186

Collaborator

(none)

Enrollment

Location

Arms

3.5

Actual Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Sep 3, 2017

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Dec 19, 2017

Arms and Interventions

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).
Other: 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.

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).

Other: 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.

Outcome Measures

Primary Outcome Measures

Effects of phototherapy on adaptation and change of cardiac Autonomic modulation. [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

Effects of phototherapy on recovery of cardiac Autonomic modulation. [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.
Effects of phototherapy on tracking daily of cardiac autonomic modulation. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Franciele Marques Vanderlei	Presidente Prudente	SP	Brazil	55

Sponsors and Collaborators

Paulista University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Franciele Marques Vanderle, PhD - Clinical Professor, Paulista University

ClinicalTrials.gov Identifier:

NCT03566186

Other Study ID Numbers:

U1111-1214-0497

First Posted:

Jun 25, 2018

Last Update Posted:

Jun 25, 2018

Last Verified:

Jun 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Franciele Marques Vanderle, PhD - Clinical Professor, Paulista University

Photobiomodulation

Autonomic nervous system

Heart rate variability

Recovery of function

Super-pulsed laser

Led light

Study Results

No Results Posted as of Jun 25, 2018