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Sensory-motor and cardiorespiratory sensory rehabilitation associated with transcranial photobiomodulation in patients with central nervous system injury: Trial protocol for a single-center, randomized, double-blind, and controlled clinical trial.

Abstract：

BACKGROUND:Central nervous system diseases such as stroke, spinal cord injury, traumatic brain injury, and multiple sclerosis can be fatal or cause sequelae, affecting sensorimotor and cardiorespiratory systems and quality of life. These subjects present a low response to aerobic and resistance exercise, due to decreased recruitment of muscle fibers and reduction of metabolic capacity. Aerobic exercises bring benefits in terms of fatigue retardation, gait improvement, regulation of the autonomic nervous system, neuroprotection of the brain, stimulation of the production of endogenous neutrotransmitters related to general well-being, and a favoring of neuroplasticity. Photobiomodulation (PBM Therapy) (previously known as low-level laser therapy), and especially transcranial PBM Therapy, has shown benefits in animals and humans such as cognitive improvement, memory, and behavioral improvement, including attenuation of depression and anxiety, and increased cortical oxygenation. The aims of this trial will be to evaluate the parameters related to the function of the musculoskeletal and cardiorespiratory system and the impact of PBM therapy on these parameters, as part of a rehabilitation and training program for people with reduced mobility. METHODS:This is a randomized, double-blind, placebo-controlled trial with 3 groups: Control, only cardiorespiratory rehabilitation (CCR), CCR with PBM Therapy (CR-PBM), CCR and placebo PBM Therapy (CR-PlaceboPBM). n = 90, 30 per group. PBM Therapy parameters: 810 nm laser, 0.028 cm, 100 mW, 3.5 W/cm, 30 seconds per point, 3 J per point, 107.1 J /cm to 3 electroencephalogram points F7 and F8 and AFz. The trial will be conducted at the University Clinics and the sessions will be 1 hour twice a week for 9 weeks. Baseline, intermediate (4th week), final (9th week), and 2-month follow-up will be performed. Muscular activation, heart rate variability, lung volumes and capacities, fatigability, exercise tolerance, cognition, and quality of life at baseline will be evaluated. Subsequent to baseline evaluations, the PBM Therapy groups will be offered laser therapy (active or inactive); all groups will then receive CCR. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov ID - NCT03751306 (approval date: November 22, 2018).

journal_name

Medicine (Baltimore)

journal_title

Medicine

authors

Pinto AP,Guimarães CL,Souza GADS,Leonardo PS,Neves MFD,Lima FPS,Lima MO,Lopes-Martins RAB

doi

10.1097/MD.0000000000015851

subject

Has Abstract

pub_date

2019-06-01 00:00:00

pages

e15851

issue

eissn

0025-7974

issn

1536-5964

pii

00005792-201906210-00004

journal_volume

pub_type

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Sensory-motor and cardiorespiratory sensory rehabilitation associated with transcranial photobiomodulation in patients with central nervous system injury: Trial protocol for a single-center, randomized, double-blind, and controlled clinical trial.