PhototherapyNCT03566186
Effects of Phototherapy Associated With Sprint and Squat Training on Cardiac Autonomic Modulation
A study testing Phototherapy and Passive recovery in people with Phototherapy and Autonomic Nervous System, run by Paulista University at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Phototherapy, Autonomic Nervous System, Training
- What is being tested?
- Phototherapy and Passive recovery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Sep 2017to 19 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patient (self-report);
- Male gender;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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%.
- Conditions
- Phototherapy, Autonomic Nervous System, Training
- Being tested
- Phototherapy, Placebo, Passive recovery
- Keywords
- Photobiomodulation, Autonomic nervous system, Heart rate variability, Recovery of function, Super-pulsed laser, Led light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyOther
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.
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).
Passive recoveryOther
Participants was remain sat for passive recovery supervised by an independent therapist during the period when the other groups are received recovery strategies.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Phototherapy |
| Placebo group | Placebo comparator | (n=14) Phase 2 training + placebo phototherapy group Receives: Other: Placebo |
| non-treatment control group | Other | (n=13) Phase 2 training + control group Receives: Other: Passive recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Compare the effects of phototherapy with placebo group and control group at recovery after exercise of heart rate variability.
Measured: 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.
Analyze and compare the change in the indices of heart rate variability in tracking daily after combined training of sprints and squats
Measured: daily, after exercise and before exercise (captation of hear rate variability for 7 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start3 Sep 2017
- Primary completion1 Oct 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhototherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paulista University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franciele Marques Vanderle, Paulista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566186
- Sponsor's protocol ID
- U1111-1214-0497
- Status last verified
- Jun 2018
- First submitted
- 28 May 2018
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phototherapy Associated With Sprint and Squat Training on Cardiac Autonomic Modulation: Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03566186
- Acronym / sponsor ID
- U1111-1214-0497
- Conditions
- Phototherapy, Autonomic Nervous System, Training
- Keywords
- Photobiomodulation, Autonomic nervous system, Heart rate variability, Recovery of function, Super-pulsed laser, Led light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Paulista UniversityUniversity, hospital or other
- Study start
- 3 Sep 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active phototherapy group | Experimental | Other: Phototherapy(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). |
| Placebo group | Placebo comparator | Other: Placebo(n=14) Phase 2 training + placebo phototherapy group |
| non-treatment control group | Other | Other: Passive recovery(n=13) Phase 2 training + control group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy patient (self-report);
- Male gender;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhototherapyPhotobiomodulation or photobiostimulation, this technique is the application of monochromatic light that can influence cellular activity through inhibition or stimulation of chemical and biological functions. | Other | Active phototherapy group |
| PlaceboThe 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 | Placebo group |
| Passive recoveryParticipants was remain sat for passive recovery supervised by an independent therapist during the period when the other groups are received recovery strategies. | Other | non-treatment control group |
Primary outcome
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
2 secondary outcomes
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).
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy and Passive recovery in people with Phototherapy and Autonomic Nervous System, run by Paulista University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.