NCT04809415

Brief Summary

In recent years, photobiomodulation has been studied as a means of increasing muscle performance in athletes and healthy individuals. This is possible due to the physiological changes that photobiomodulation therapy can promote. Moreover, given a large number of existing studies on the subject, some directions for future research have been established. For example, future research was established, the relationship between power and time because with high power, it will achieve the same energy with shorter application times. However, irradiation may not be offered for the minimum recommended time. Therefore, this study aims to compare different powers and, consequently, different application times for muscle performance in healthy individuals. For this, 42 participants will be recruited, males between 18 to 40 years old, without recent musculoskeletal injury or cardiorespiratory problems. The participants will participate in 3 evaluations containing functional and physiological variables and ten training sessions of lower limbs with previous photobiomodulation therapy application, comparing devices with a power of 0.864W and 1.864W. 0.864W and 1.2W. Lower limbs training will be composed of stiff and squat exercises twice a week, for five weeks. In the pre- and post-intervention evaluations, the following parameters will be evaluated isokinetic apparatus, body composition, and functionality of the vertical jump. For data analysis, we will use a normality test to verify the distribution and statistical tests will be used for intra and intra and intergroup comparisons, considering 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
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

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

March 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

March 17, 2021

Last Update Submit

October 18, 2022

Conditions

Keywords

Physical TherapyPhotobiomodulationMuscle StrengthPowerAthletic 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

    1 year

Study Arms (3)

Sham Group (G-S)

SHAM COMPARATOR

The LED blanket 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: Sham

300J Infrared Blanket LED Group (Blanket-300J)

EXPERIMENTAL

The LED blanket with a wavelength of 940nm, energy of 300J, will be applied across the quadriceps and hamstrings bilaterally, just before the strength training protocol.

Other: Photobiomodulation

300J Infrared Cluster LED Group (Cluster-300J)

EXPERIMENTAL

The LED Cluster with a wavelength of 850 nm, energy of 300 J, will be applied to the quadriceps (5 points) and hamstrings (5 points), bilaterally, just before the strength training protocol.

Other: Photobiomodulation

Interventions

Photobiomodulation consists of irradiation by light in order to achieve photochemical and photophysical outcomes.

300J Infrared Blanket LED Group (Blanket-300J)300J Infrared Cluster LED Group (Cluster-300J)
ShamOTHER

Simulation of the application of photobiomodulation therapy.

Sham Group (G-S)

Eligibility Criteria

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

You may qualify if:

  • \- 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 Therapysalicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Carlos E 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
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 22, 2021

Study Start

May 1, 2021

Primary Completion

December 31, 2021

Study Completion

October 1, 2022

Last Updated

October 21, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

The datas will be sharing in form of manuscript.

Locations