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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03566186
Other study ID # U1111-1214-0497
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2017
Est. completion date December 19, 2017

Study information

Verified date June 2018
Source Paulista University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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%.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date December 19, 2017
Est. primary completion date October 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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
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).
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.

Locations

Country Name City State
Brazil Franciele Marques Vanderlei Presidente Prudente SP

Sponsors (1)

Lead Sponsor Collaborator
Paulista University

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Effects of phototherapy on recovery of cardiac Autonomic modulation. Compare the effects of phototherapy with placebo group and control group at recovery after exercise of heart rate variability. 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).
Secondary Effects of phototherapy on tracking daily of cardiac autonomic modulation. Analyze and compare the change in the indices of heart rate variability in tracking daily after combined training of sprints and squats daily, after exercise and before exercise (captation of hear rate variability for 7 minutes)
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