Phototherapy Applied During Combined Training

NCT02918916 | Unknown DMC

• 1 other identifier: 2015/25219-0
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Change from 6-week Maximal voluntary isometric contraction at 12-week of training

  Prior to the MVIC evaluation, participants will conduct a warm up consisting of 10 repetitions of knee flexion-extension at 180°.s-1 throughout the range of motion. The MIVC will be determined by the highest maximal isometric torque over three contractions of five seconds at 60° of knee flexion (with 0° corresponding to the maximum extension). The repetitions will be separated by a 2-minute rest interval. Participants will be instructed to perform maximal contractions and verbally encouraged by the researcher during the evaluation.

  Change between 6-week and 12-week of training

Secondary Outcomes (11)

• Strength and power test

  Baseline, after 6-week, after 13-week of training

• Maximum oxygen consumption (VO2max)

  Baseline, after 6-week, after 13-week of training

• Squat jump

  Baseline, after 6-week, after 13-week of training

• Sprint test

  Baseline, after 6-week, after 13-week of training

• Muscle soreness

  Baseline, 5-week, after 6-week, 12-week, after 13-week of training

Study Arms (3)

Active phototherapy group

EXPERIMENTAL

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).

Other: Phototherapy

Placebo phototherapy group

PLACEBO COMPARATOR

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.

Other: Placebo

Control group

NO INTERVENTION

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.

Interventions

Phototherapy OTHER

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

Also known as: Low-level laser therapy, Light-emitting diode

Active phototherapy group

Placebo OTHER

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

Placebo phototherapy group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• São Paulo State University: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Interventions

Phototherapy; Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Laser Therapy

Study Officials

• Carlos Pastre, PhD

  Univ Estadual Paulista

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Pastre, PhD

CONTACT

+551832295528; pastre@fct.unesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 29, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 29, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share