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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

Tracking Information
First Submitted Date  ICMJE March 11, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date October 20, 2016
Study Start Date  ICMJE March 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 16, 2016)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phototherapy Applied in Association With Muscular Training
Official Title  ICMJE Phototherapy Applied in Association With Muscular Training: Evaluation of Different Moments of Applications
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Muscle Adaptation
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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.

    Intervention: Device: Active or Placebo Phototherapy (MR4)
  • 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.

    Intervention: Device: Active or Placebo Phototherapy (MR4)
  • 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.

    Intervention: Device: Active or Placebo Phototherapy (MR4)
  • 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.

    Intervention: Device: Active or Placebo Phototherapy (MR4)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2016)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02715050
Other Study ID Numbers  ICMJE PhD437.894
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adriane Aver Vanin, University of Nove de Julho
Study Sponsor  ICMJE University of Nove de Julho
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Study Director: Ernesto Leal-Junior, PhD University of Nove de Julho
PRS Account University of Nove de Julho
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP