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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02474602
Other study ID # Nove de Julho University
Secondary ID 2013/19355-3
Status Completed
Phase N/A
First received June 11, 2015
Last updated February 2, 2016
Start date June 2014
Est. completion date August 2015

Study information

Verified date February 2016
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date August 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Muscle Development in Association to Phototherapy

Intervention

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.

Locations

Country Name City State
Brazil Nove de Julho University São Paulo SP

Sponsors (2)

Lead Sponsor Collaborator
University of Nove de Julho Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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 — View Citation

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. Review. — View Citation

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. Epub 2006 Oct 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum voluntary contraction in the isokinetic dynamometer (MVC) Functional performance measure 12 weeks No
Secondary 1-Repetition Maximum test in the leg press and leg extension machines (1-RM) Functional performance measure 12 weeks No
Secondary Thigh perimetry 12 weeks No