NCT03860766

Brief Summary

Background: Photobiomodulation has been explored for years, with wide clinical use for wound healing and analgesia in varied orthopedic conditions, but the number of research and clinical use has increased during the last decade. Furthermore, considering the performance, the current literature is conflicting and restricted, with divergences in wavelength, power and energy density applied. Therefore, analyze different doses for a answer in short and long time, associated with capacities of strength, fatigue resistance and functional performance of handball players and healthy individuals becomes necessary. Objective: To analyze the effects of the application of LED photobiomodulation on the capacities of strength, functional efficiency, temperature and fatigue resistance of handball players and healthy individuals. Method: The study sample will be composed of 56 male individuals randomly allocated into four groups: LED 50J (G-50J), LED 240J (G-240J), LED 50-240J (G-50-240J) - progressive dose and Sham (G-S). The volunteers will be submitted to an evaluation of muscle performance and functional performance, metabolic, and physiological evaluation. After initial tests, in five consecutive weeks, the LEDT (940nm - infrared) will be applied to the quadriceps femoris muscle and hamstrings, bilaterally, associated with a muscle strength protocol. After 24 hours of the last application TLED, the tests will be repeated. Seven days after the last intervention will be performed a follow-up. For analysis, normality tests will be used to verify the distribution and adequate statistical tests for the appropriate intra and intergroup comparisons, being considered two factors in the comparisons, time, and group. A significance level of 5% will be adopted.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 8, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

February 28, 2019

Last Update Submit

July 19, 2021

Conditions

Keywords

IsokineticElectromyographyPhysiotherapyAthletic Performance

Outcome Measures

Primary Outcomes (1)

  • difference of maximal voluntary contraction

    The study was designed to detect a difference of maximal voluntary contraction between the groups, following the interventions

    3 years

Study Arms (4)

Sham Group (G-S)

SHAM COMPARATOR

The LED will be positioned across the quadriceps and hamstring bilaterally, however, there will be no light emission. However, the volunteer will perform the strength training protocol.

Other: Photobiomodulation

50J Infrared LED Group (G-50J)

EXPERIMENTAL

The LED with a wavelength of 940nm, 50J power, will be applied throughout the quadriceps and hamstrings bilaterally, just before the strength training protocol.

Other: Photobiomodulation

240J Infrared LED Group (G-240J)

EXPERIMENTAL

The LED with a wavelength of 940nm, 240J power, will be applied across the quadriceps and hamstrings bilaterally, just before the strength training protocol.

Other: Photobiomodulation

Progressive dose infrared LED group (G-50-240J)

EXPERIMENTAL

The LED with a wavelength of 940nm, initial energy of 50J with an increment of 38J each week to the final energy of 240J, will be applied throughout extension of the quadriceps and hamstrings bilaterally, immediately prior to the performance of the strength training protocol

Other: Photobiomodulation

Interventions

An LED blanket with 267 infrared lamps with predetermined doses will be used, given a wavelength of 940nm, for 5 weeks, it will be applied by all extension of the quadriceps and hamstrings bilaterally, just before the force training protocol for the groups intervention or simulation for the sham group. Photochemical or photophysical effects are expected from its application.

240J Infrared LED Group (G-240J)50J Infrared LED Group (G-50J)Progressive dose infrared LED group (G-50-240J)Sham Group (G-S)

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Handball players with the participation of at least one official match in the last year and attend 70% of the team's activities during the current season; or
  • Healthy individuals;

You may not qualify if:

  • musculoskeletal injury in the last three months;
  • cardiovascular diseases;
  • use of anabolic, anti-inflammatory and analgesic drugs 72 hours before the evaluations;
  • use of alcohol and illicit drugs during the collection period;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (3)

  • American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.

    PMID: 19204579BACKGROUND
  • Ferraresi C, Beltrame T, Fabrizzi F, do Nascimento ES, Karsten M, Francisco Cde O, Borghi-Silva A, Catai AM, Cardoso DR, Ferreira AG, Hamblin MR, Bagnato VS, Parizotto NA. Muscular pre-conditioning using light-emitting diode therapy (LEDT) for high-intensity exercise: a randomized double-blind placebo-controlled trial with a single elite runner. Physiother Theory Pract. 2015 Jul;31(5):354-61. doi: 10.3109/09593985.2014.1003118. Epub 2015 Jan 14.

    PMID: 25585514BACKGROUND
  • Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available.

    PMID: 25844681BACKGROUND

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Carlos Girasol, Student

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 4, 2019

Study Start

July 8, 2020

Primary Completion

July 19, 2021

Study Completion

July 19, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

The datas will be sharing in form of manuscript.

Locations