- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03566186
Effects of Phototherapy Associated With Sprint and Squat Training on Cardiac Autonomic Modulation
June 11, 2018 updated by: Franciele Marques Vanderle, Paulista University
Effects of Phototherapy Associated With Sprint and Squat Training on Cardiac Autonomic Modulation: Randomized, Placebo-controlled Trial
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%.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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SP
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Presidente Prudente, SP, Brazil, 55
- Franciele Marques Vanderlei
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / 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).
|
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.
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PLACEBO_COMPARATOR: Placebo group
(n=14) Phase 2 training + placebo phototherapy group
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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).
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OTHER: non-treatment control group
(n=13) Phase 2 training + control group
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Participants was remain sat for passive recovery supervised by an independent therapist during the period when the other groups are received recovery strategies.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Analyzed and compare the effects of phototherapy with different light sources and wavelengths applied during training combined at heart rate variability
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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Compare the effects of phototherapy with placebo group and control group at recovery after exercise of heart rate variability.
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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).
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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)
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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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daily, after exercise and before exercise (captation of hear rate variability for 7 minutes)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 3, 2017
Primary Completion (ACTUAL)
October 1, 2017
Study Completion (ACTUAL)
December 19, 2017
Study Registration Dates
First Submitted
May 28, 2018
First Submitted That Met QC Criteria
June 11, 2018
First Posted (ACTUAL)
June 25, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 25, 2018
Last Update Submitted That Met QC Criteria
June 11, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- U1111-1214-0497
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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