NCT01770938

Brief Summary

Muscle performance is largely influenced by modulations in gene expressions of muscle tissue. In this context, light-emitting diode therapy (LEDT) has been used to improve muscle performance in experimental models and human researches. Thereby, the investigators examined modulations in gene expression of muscle tissue as well as biochemical, biomechanic and histologic adaptations influenced by exercise associated to LEDT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable healthy

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

May 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 23, 2014

Status Verified

September 1, 2014

Enrollment Period

2 months

First QC Date

September 15, 2012

Last Update Submit

September 19, 2014

Conditions

Healthy

Keywords

Light-emitting diode therapyMuscle performanceGene expressionFunctional performance

Outcome Measures

Primary Outcomes (1)

  • Modulations on muscle gene expression by RT-PCR

    12 weeks

Secondary Outcomes (4)

  • Muscle performance in leg press device

    12 weeks

  • Muscle performance in leg extension device

    12 weeks

  • Muscle performance in isokinetic dynamometer

    12 weeks

  • Gene expression

    12 weeks

Other Outcomes (1)

  • Immunohistochemical analysis

    12 weeks

Study Arms (2)

Effective light-emitting diode therapy and training

ACTIVE COMPARATOR

Effects of effective light-emitting diode therapy therapy on muscle performance of young males submitted to physical strength training

Device: Effective light-emitting diode therapy

Placebo light-emitting diode therapy and training

PLACEBO COMPARATOR

Effects of placebo light-emitting diode therapy on muscle performance of young males submitted to physical strength training

Device: Placebo light-emitting diode therapy

Interventions

Effective light-emitting diode therapyDEVICE
Also known as: LED, LED therapy, Light-emitting diode therapy
Effective light-emitting diode therapy and training
Placebo light-emitting diode therapyDEVICE
Also known as: LED, LED therapy, Light-emitting diode therapy
Placebo light-emitting diode therapy and training

Eligibility Criteria

Age18 Years - 28 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males aged between 18 and 28 years with a body mass index (BMI) equal to or less than 26 kg/m2,
  • moderated pattern of physical activity

You may not qualify if:

  • previous injury to the femoral quadriceps or hamstring muscles (within 6 months prior to study),
  • osseous or articular disorder in the lower limbs,
  • cardiovascular system disorders,
  • systemic disease, and
  • taking prescription medicines or using dietary supplements such as muscle mass builders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

Related Publications (2)

  • Vieira WH, Ferraresi C, Perez SE, Baldissera V, Parizotto NA. Effects of low-level laser therapy (808 nm) on isokinetic muscle performance of young women submitted to endurance training: a randomized controlled clinical trial. Lasers Med Sci. 2012 Mar;27(2):497-504. doi: 10.1007/s10103-011-0984-0. Epub 2011 Aug 26.

    PMID: 21870127BACKGROUND

  • Ferraresi C, de Brito Oliveira T, de Oliveira Zafalon L, de Menezes Reiff RB, Baldissera V, de Andrade Perez SE, Matheucci Junior E, Parizotto NA. Effects of low level laser therapy (808 nm) on physical strength training in humans. Lasers Med Sci. 2011 May;26(3):349-58. doi: 10.1007/s10103-010-0855-0. Epub 2010 Nov 18.

    PMID: 21086010BACKGROUND

Study Officials

  • Cleber Ferraresi, MSc

    Universidade Federal de Sao Carlos

    PRINCIPAL INVESTIGATOR

  • Nivaldo A Parizotto, PhD

    Universidade Federal de Sao Carlos

    STUDY DIRECTOR

  • Vanderlei S Bagnato, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

September 15, 2012

First Posted

January 18, 2013

Study Start

May 1, 2012

Primary Completion

July 1, 2012

Study Completion

September 1, 2014

Last Updated

September 23, 2014

Record last verified: 2014-09

Locations

BR(1)