NCT02715050

Brief Summary

The effects of phototherapy has been widely studied by some research groups. The investigators know that there are positive results with light application to improve muscle performance and delay fatigue. However, there are few studies showing its´ effects on muscular training. Therefore, the aim of this study was to assess the effects of phototherapy applied at different times during 12 weeks of strength training. For such, 48 volunteers, healthy male, from 18 to 35 years old were recruited to perform a strength training protocol for the anterior muscle of the thigh development. Volunteers performed the training protocol three times a week for 12 weeks. There were assessed isometric peak torque in isokinetic dynamometer, concentric peak torque, 1-repetition maximum test in the leg extension and leg press machines and bilateral thigh perimetry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

March 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

March 11, 2016

Last Update Submit

October 18, 2016

Conditions

Keywords

phototherapyphotobiostimulationmuscle trainingmuscular adaptation

Outcome Measures

Primary Outcomes (2)

  • Change from baseline Maximum voluntary contraction in the isokinetic dynamometer (MVC) at 12 weeks

    Functional performance measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training

    12 weeks

  • Change from baseline Concentric Torque at 12 weeks

    Functional performance measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training

    12 weeks

Secondary Outcomes (1)

  • 1-RM test

    12 weeks

Other Outcomes (1)

  • Thigh perimetry

    12 weeks

Study Arms (4)

Group A - Active or Placebo Phototherapy

EXPERIMENTAL

Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group A, received program 1 before strength training, and the same program 1 after training.

Device: Active or Placebo Phototherapy (MR4)

Group B - Active or Placebo Phototherapy

EXPERIMENTAL

Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group B, received program 1 before strength training, and program 2 after training.

Device: Active or Placebo Phototherapy (MR4)

Group C - Active or Placebo Phototherapy

EXPERIMENTAL

Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group C, received program 2 before strength training, and program 1 after training.

Device: Active or Placebo Phototherapy (MR4)

Group D - Active or Placebo Phototherapy

EXPERIMENTAL

Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group D, received program 2 before strength training, and program 2 after training.

Device: Active or Placebo Phototherapy (MR4)

Interventions

Also known as: MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)
Group A - Active or Placebo PhototherapyGroup B - Active or Placebo PhototherapyGroup C - Active or Placebo PhototherapyGroup D - Active or Placebo Phototherapy

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy individuals,
  • active, that performed less than two exercise sessions per week
  • when they presented musculoskeletal injury to the hips or knees in the previous 2 months,
  • used pharmacological agents or nutritional supplements regularly, and
  • Subjects that did not attend a minimum rate of 80% of all strength training sessions
  • Suffered musculoskeletal injury during the ongoing of the study were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo, 01504-001, Brazil

Location

Related Publications (3)

  • Leal-Junior EC, Vanin AA, Miranda EF, de Carvalho Pde T, Dal Corso S, Bjordal JM. Effect of phototherapy (low-level laser therapy and light-emitting diode therapy) on exercise performance and markers of exercise recovery: a systematic review with meta-analysis. Lasers Med Sci. 2015 Feb;30(2):925-39. doi: 10.1007/s10103-013-1465-4. Epub 2013 Nov 19.

    PMID: 24249354BACKGROUND
  • Seynnes OR, de Boer M, Narici MV. Early skeletal muscle hypertrophy and architectural changes in response to high-intensity resistance training. J Appl Physiol (1985). 2007 Jan;102(1):368-73. doi: 10.1152/japplphysiol.00789.2006. Epub 2006 Oct 19.

    PMID: 17053104BACKGROUND
  • Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.

Study Officials

  • Ernesto Leal-Junior, PhD

    University of Nove de Julho

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd researcher

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 22, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

October 20, 2016

Record last verified: 2016-10

Locations