NCT03566186

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2017

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

28 days

First QC Date

May 28, 2018

Last Update Submit

June 11, 2018

Conditions

Keywords

PhotobiomodulationAutonomic nervous systemHeart rate variabilityRecovery of functionSuper-pulsed laserLed light

Outcome Measures

Primary Outcomes (1)

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

    Analyzed and compare the effects of phototherapy with different light sources and wavelengths applied during training combined at heart rate variability

    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)

Secondary Outcomes (2)

  • 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).

  • Effects of phototherapy on tracking daily of cardiac autonomic modulation.

    daily, after exercise and before exercise (captation of hear rate variability for 7 minutes)

Study Arms (3)

Active phototherapy group

EXPERIMENTAL

(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

Placebo group

PLACEBO COMPARATOR

(n=14) Phase 2 training + placebo phototherapy group

Other: Placebo

non-treatment control group

OTHER

(n=13) Phase 2 training + control group

Other: Passive recovery

Interventions

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.

Active phototherapy group
PlaceboOTHER

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).

Placebo group

Participants was remain sat for passive recovery supervised by an independent therapist during the period when the other groups are received recovery strategies.

non-treatment control group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, 55, Brazil

Location

MeSH Terms

Interventions

Phototherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD - Clinical Professor

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 25, 2018

Study Start

September 3, 2017

Primary Completion

October 1, 2017

Study Completion

December 19, 2017

Last Updated

June 25, 2018

Record last verified: 2018-06

Locations