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Open Access Study protocol

Efficacy of pre-exercise low-level laser therapy on isokinetic muscle performance in individuals with type 2 diabetes mellitus: study protocol for a randomized controlled trial

Cid André Fidelis de Paula Gomes12*, Ernesto Cesar Pinto Leal-Junior123, Daniela Aparecida Biasotto-Gonzalez23, Yasmin El-Hage2, Fabiano Politti23, Tabajara de Oliveira Gonzalez2, Almir Vieira Dibai-Filho4, Adriano Rodrigues de Oliveira12, Marcelo Frigero12, Fernanda Colella Antonialli3, Adriane Aver Vanin3 and Paulo de Tarso Camillo de Carvalho123

Author Affiliations

1 Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho (UNINOVE), Av. Dr. Adolfo Pinto, 109. Água Branca, São Paulo, SP 05001-100, Brazil

2 Department of Physical Therapy, Universidade Nove de Julho (UNINOVE), Av. Dr. Adolfo Pinto, 109. Água Branca, São Paulo, SP 05001-100, Brazil

3 Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho (UNINOVE), Av. Dr. Adolfo Pinto, 109. Água Branca, São Paulo, SP 05001-100, Brazil

4 Postgraduate Program in Rehabilitation and Functional Performance, University of São Paulo, Ribeirão Preto, v. Bandeirantes, 3900 - Curso de Fisioterapia/Casa 2, Monte Alegre, São Paulo 14049-900, Brazil

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Trials 2014, 15:116  doi:10.1186/1745-6215-15-116

Published: 9 April 2014

Abstract

Background

Type 2 diabetes, also known non-insulin-dependent diabetes, is the most prevalent type of the disease and involves defects in the secretion and action of insulin. The aim of the proposed study is to evaluate the efficacy of pre-exercise low-level laser therapy (LLLT) on muscle performance of the quadriceps femoris in individuals with type 2 diabetes.

Methods/Design

A double-blind, randomized, controlled clinical trial will be carried out in two treatment phases. In the first phase, quadriceps muscle performance will be evaluated using an isokinetic dynamometer and the levels of creatine kinase and lactate dehydrogenase (biochemical markers of muscle damage) will be determined. The participants will then be allocated to four LLLT groups through a randomization process using opaque envelopes: Group A (4 Joules), Group B (6 Joules), Group C (8 Joules) and Group D (0 Joules; placebo). Following the administration of LLLT, the participants will be submitted to an isokinetic eccentric muscle fatigue protocol involving the quadriceps muscle bilaterally. Muscle performance and biochemical markers of muscle damage will be evaluated again immediately after as well as 24 and 48 hours after the experimental protocol. One week after the last evaluation the second phase will begin, during which Groups A, B and C will receive the LLLT protocol that achieved the best muscle performance in phase 1 for a period of 4 weeks. At the end of this period, muscle performance will be evaluated again. The protocol for this study is registered with the World Health Organization under Universal Trial Number U1111-1146-7109.

Discussion

The purpose of this randomized clinical trial is to evaluate the efficacy of pre-exercise LLLT on the performance of the quadriceps muscle (peak torque, total muscle work, maximum power and fatigue index – normalized by body mass) in individuals with DM-2. The study will support the practice of evidence-based to the use of LLLT in improving muscle performance in Individuals with DM-2. Data will be published after the study is completed.

Keywords:
Diabetes Mellitus; Low-Level Laser Therapy; Muscle; Skeletal; Quadriceps Muscle; Physical Therapy Modalities