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Phototherapy Applied in Association With Muscular Training

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ClinicalTrials.gov Identifier: NCT02715050
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : October 20, 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 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.

Condition or disease Intervention/treatment Phase
Muscle Adaptation 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 muscular training protocol. Subjects practiced a protocol training with 60% of the load followed by 80% of the load, measured through 1-repetition maximum test, in all sessions of the training protocol. The training protocol consisted in performing 3 sets of 7 repetitions with 60% of 1-RM, and 4 set of 7 repetitions with 80% of 1-RM. This protocol was performed in every sessions, three times a week, employing leg press and leg extension 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), concentric torque, bilateral thigh perimetry and 1-repetition maximum test (1-RM).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Phototherapy Applied in Association With Muscular Training: Evaluation of Different Moments of Applications
Study Start Date : March 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

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

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)
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

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)
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

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)
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

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)
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. Change from baseline Maximum voluntary contraction in the isokinetic dynamometer (MVC) at 12 weeks [ Time Frame: 12 weeks ]
    Functional performance measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training

  2. Change from baseline Concentric Torque at 12 weeks [ Time Frame: 12 weeks ]
    Functional performance measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training


Secondary Outcome Measures :
  1. 1-RM test [ Time Frame: 12 weeks ]
    Functional performance measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training. This test estimated the load of the exercises.


Other Outcome Measures:
  1. Thigh perimetry [ Time Frame: 12 weeks ]
    Muscle mass measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training.



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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:

  • 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.

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): NCT02715050


Locations
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Brazil
Universidade Nove de Julho
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
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Study Director: Ernesto Leal-Junior, PhD University of Nove de Julho
Publications of Results:
Other Publications:
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Responsible Party: Adriane Aver Vanin, Phd researcher, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02715050    
Other Study ID Numbers: PhD437.894
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Keywords provided by Adriane Aver Vanin, University of Nove de Julho:
phototherapy
photobiostimulation
muscle training
muscular adaptation