Phototherapy Applied During Combined Training

NCT ID: NCT02918916

Last Updated: 2016-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-03-31

Brief Summary

Introduction: Recent studies have shown positive results from the application of phototherapy for the improvement of performance and acceleration of the recovery process both in the application before and after exercise. However, the effects of phototherapy during combined training and after a primary adaptation process remain unclear.

Research objectives: The primary objective of the study is to analyze and compare the effects of phototherapy using different light sources (laser and light emmiting diode - LED) interacting with combined training on clinical, functional, and psychological outcomes and vascular endothelial growth factor. The secondary objective is to compare the benefits provided by phototherapy in participants with different levels of training adaptation.

Design: A controlled trial, double-blind, placebo-controlled will be conducted with stratified randomization and concealed allocation.

Participants and Setting: After fulfilling the eligibility criteria, forty-five male participants will participate in the study.

Procedure: In phase 1, the participants will perform six-weeks of combined training (sprints and squats). In phase 2, participants will be allocated, through stratified randomization (based on adaptation capacity to training), into three groups: active phototherapy group (AG), placebo phototherapy group (PG), and control group (CG). A new six-week training period will then start. In this phase the participants will carry out training normally with the adjusted loads and between sprints and squats will receive the recovery strategy related to the group to which they belong.

Intervention: Active and placebo phototherapy will be applied by a trained therapist, between sprints and squats. During the period of recovery strategies for the AG and PG, the CG participants will remain seated for passive recovery, supervised by an independent therapist.

Measurements: The measurements include clinical, functional, and psychological outcomes and vascular endothelial growth factor.

Detailed Description

Introduction: Recent studies have shown positive results from the application of phototherapy for the improvement of performance and acceleration of the recovery process both in the application before and after exercise. However, the effects of phototherapy during combined training and after a primary adaptation process remain unclear.

Research objectives: The primary objective of the study is to analyze and compare the effects of phototherapy using different light sources (laser and LEDs) interacting with combined training on clinical, functional, and psychological outcomes and vascular endothelial growth factor. The secondary objective is to compare the benefits provided by phototherapy in participants with different levels of training adaptation.

Design: A controlled trial, double-blind, placebo-controlled will be conducted with stratified randomization and concealed allocation.

Participants and Setting: After fulfilling the eligibility criteria, forty-five male participants will participate in the study. The inclusion criteria include: healthy male, aged between 18-30 years who agree to participate in the study. Participants with the following will be excluded from the study: presence of anemia, inflammation, diabetes, history of metastasis or muscle injury in the lower limbs or spine in the previous six months, and occurrence of musculoskeletal injury during the study.

Procedure: In phase 1, the participants will perform six-weeks of combined training (sprints and squats). In phase 2, participants will be allocated, through stratified randomization (based on adaptation capacity to training), into three groups: active phototherapy group (AG), placebo phototherapy group (PG), and control group (CG). A new six-week training period will then start. In this phase the participants will carry out training normally with the adjusted loads and between sprints and squats will receive the recovery strategy related to the group to which they belong.

Intervention: Active and placebo phototherapy will be applied by a trained therapist, between sprints and squats, bilaterally to six sites of the quadriceps in direct contact with the skin. The dosage applied will be 30J per site. The same procedures as the AG will be applied to the PG, however the emitter will be disabled. During the period of recovery strategies for the AG and PG, the CG participants will remain seated for passive recovery, supervised by an independent therapist.

Measurements: The measurements include clinical (muscle soreness, pain threshold, perception of exertion, and perception of recovery), functional (squat strength and power, maximal voluntary isometric contraction, maximal incremental test, squat jump, and sprint test), and psychological (self-assessments of readiness for exercise, fatigue, vigor, pain, and belief of intervention effectiveness) outcomes and vascular endothelial growth factor.

Analysis: For analysis of functional outcomes, data normality will be checked by the Kolmogorov-Smirnov test with changes from baseline followed by the Student T test for comparisons. For other outcomes, sphericity of the data will be tested by the Mauchly's test. In case of violation of the sphericity assumption, Greenhouse-Geisser corrections will be used. Data will be analyzed using repeated-measures analysis of variance (Bonferroni's test will be performed when required), which provide information on time, group, and interaction effects. A significance level of 5% will be assumed for all statistical analysis.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active phototherapy group

Phototherapy will be applied between sprint and squat training (exactly 10 minutes before squat training).

Active phototherapy will be applied by a trained therapist using a MR4 LaserShower 50 4D emitter (Multi Radiance Medical, USA), bilaterally to six sites of the quadriceps (two centrally - rectus femoris and vastus intermedius; two laterally - vastus lateralis; two medially - vastus medially) in direct contact with the skin.

The optical power will be calibrated before irradiation in each participant using a Thorlabs thermal power meter (Model S322C, Thorlabs, Newton, New Jersey, USA).

Group Type: EXPERIMENTAL

Phototherapy

Intervention Type: OTHER

The dosage applied will be 30 Joules per site (180 Joules per muscle). Parameters are described in the attached document.

Placebo phototherapy group

Placebo will be applied between sprint and squat training (exactly 10 minutes before squat training). Placebo phototherapy will be applied by a trained therapist using a MR4 LaserShower 50 4D emitter (Multi Radiance Medical, USA), bilaterally to six sites of the quadriceps (two centrally - rectus femoris and vastus intermedius; two laterally - vastus lateralis; two medially - vastus medially) in direct contact with the skin. To receive active or placebo phototherapy the participant will be placed in the supine position.

The same procedures as in the active phototherapy group will be applied to the placebo phototherapy group; however the emitter will be disabled.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The same procedures as in the active phototherapy group will be applied to the placebo phototherapy group; however the emitter will be disabled.

Control group

Passive recovery will be applied between sprint and squat training (exactly 10 minutes before squat training). During the period when the other groups are receiving recovery strategies, the control group participants will remain seated for passive recovery, supervised by an independent therapist.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Phototherapy

The dosage applied will be 30 Joules per site (180 Joules per muscle). Parameters are described in the attached document.

Intervention Type: OTHER

Placebo

The same procedures as in the active phototherapy group will be applied to the placebo phototherapy group; however the emitter will be disabled.

Intervention Type: OTHER

Other Intervention Names

Low-level laser therapy; Light-emitting diode

Eligibility Criteria

Inclusion Criteria

• Healthy (self-report);
• Male gender;
• Aged between 18-30 years;
• Agreement to participate through signed statement of informed consent

Exclusion Criteria

• Presence of anemia, inflammation, or diabetes;
• History of metastasis.
• History of muscle injury in the lower limbs or spine in the previous six months;
• Occurrence of musculoskeletal injury during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

São Paulo State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Pastre, PhD

Role: PRINCIPAL_INVESTIGATOR

Univ Estadual Paulista

Central Contacts

Carlos Pastre, PhD

Role: CONTACT

pastre@fct.unesp.br

+551832295528

Study Documents

Document Type: Tables. Training program, Phototherapy parameters, Time point of outcomes

View Document

Other Identifiers

2015/25219-0

Identifier Type: -

Identifier Source: org_study_id