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Phototherapy Applied in Association With Strength Training

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ClinicalTrials.gov Identifier: NCT02474602
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : February 4, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Adriane Aver Vanin, University of Nove de Julho

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 twice a week for 12 weeks. There were assessed isometric peak torque in isokinetic dynamometer, 1-repetition maximum test in the leg extension and leg press machines and bilateral thigh perimetry.

Condition or disease Intervention/treatment Phase
Muscle Development in Association to Phototherapy Device: Active or Placebo Phototherapy (MR4) Not Applicable

Detailed Description:

This is a clinical, randomized, controlled placebo and double-blind study. Forty-eight participants performed strength training protocol. Subjects practiced a protocol training with 80% of the load, measured through 1-repetition maximum test. The training protocol consisted in performing 5 sets of 10 repetitions, twice a week, employing leg extension and leg press machines.

Phototherapy, active or placebo, were applied in 6 different points of anterior muscle of the thigh before and after each training session. Only one investigator, that did not participate in any phase of the assessments and trainings sessions, knew about what program is active or placebo in phototherapy device. Randomisation carried out by a simple drawing of lots (A, B, C, or D) in the first visit. The phototherapy unit emitted the same sound regardless of the program used, active or placebo. Either strength training lasted 12 weeks and assessments were performed at baseline, 4, 8 and 12 weeks. There were evaluated maximal voluntary contraction (MVC), bilateral thigh perimetry and 1-repetition maximum test (1-RM).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Phototherapy Applied in Association of Muscle Training: Evaluation of Different Irradiation Protocols
Study Start Date : June 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: Group A - Active or Placebo Phototherapy

The phototherapy 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)
Participants performed a strength training. Forty-eight subjects practiced a training protocol with 80% of the load, measured through 1-repetition maximum test. The strength training lasted 12 weeks and the evaluations were done monthly. Phototherapy, active or placebo, were applied in 6 different points of quadriceps muscle depending the group randomized, before and after each training session.
Other Name: MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)

Experimental: Group B - Active or Placebo Phototherapy

The phototherapy 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)
Participants performed a strength training. Forty-eight subjects practiced a training protocol with 80% of the load, measured through 1-repetition maximum test. The strength training lasted 12 weeks and the evaluations were done monthly. Phototherapy, active or placebo, were applied in 6 different points of quadriceps muscle depending the group randomized, before and after each training session.
Other Name: MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)

Experimental: Group C - Active or Placebo Phototherapy

The phototherapy 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)
Participants performed a strength training. Forty-eight subjects practiced a training protocol with 80% of the load, measured through 1-repetition maximum test. The strength training lasted 12 weeks and the evaluations were done monthly. Phototherapy, active or placebo, were applied in 6 different points of quadriceps muscle depending the group randomized, before and after each training session.
Other Name: MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)

Experimental: Group D - Active or Placebo Phototherapy'

The phototherapy 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 2 before strength training, and the same program 2 after training.

Device: Active or Placebo Phototherapy (MR4)
Participants performed a strength training. Forty-eight subjects practiced a training protocol with 80% of the load, measured through 1-repetition maximum test. The strength training lasted 12 weeks and the evaluations were done monthly. Phototherapy, active or placebo, were applied in 6 different points of quadriceps muscle depending the group randomized, before and after each training session.
Other Name: MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)




Primary Outcome Measures :
  1. Maximum voluntary contraction in the isokinetic dynamometer (MVC) [ Time Frame: 12 weeks ]
    Functional performance measure


Secondary Outcome Measures :
  1. 1-Repetition Maximum test in the leg press and leg extension machines (1-RM) [ Time Frame: 12 weeks ]
    Functional performance measure

  2. Thigh perimetry [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

There were included in the study

  • healthy individuals,
  • active,
  • aged between 18 and 35 years old,
  • male,
  • presenting no history of musculoskeletal injury in the regions of the hip and knee in the two months prior to the study.
  • that are not making use of pharmacological agents and / or nutritional supplements, and
  • that have at least 80% of attendance to training.

Exclusion Criteria:

The participants were excluded if they

  • present some musculoskeletal injury during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474602


Locations
Brazil
Nove de Julho University
São Paulo, SP, Brazil, 01504-001
Sponsors and Collaborators
University of Nove de Julho
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Director: Ernesto Cesar P Leal Junior, PhD University of Nove de Julho

Publications of Results:
Other Publications:
Responsible Party: Adriane Aver Vanin, MS, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02474602     History of Changes
Other Study ID Numbers: Nove de Julho University
2013/19355-3 ( Other Grant/Funding Number: FAPESP-Brazil )
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016

Keywords provided by Adriane Aver Vanin, University of Nove de Julho:
phototherapy
strength training
photobiostimulation
muscle development