Aerobic Exercise and Transcranial Low Laser Therapy in Patients With Central Nervous System Injury

Surgery Clinical Trial

Official title: Sensory-Motor and Cardiorespiratory Rehabilitation Associated With Transcranial Laser Therapy in Patients With Central Nervous System Injury

Status Not yet recruiting

Clinical Trial Summary

Objective of this protocol will be to evaluate the parameters related to the function of the musculoskeletal and cardiorespiratory system, through a rehabilitation and training program for people with acquired central nervous system and multiple sclerosis. The study will consist of volunteers with acquired CNS lesions and multiple sclerosis of both sexes, between 18 and 85 years old, and who wander with or without aid devices, randomly divided into 3 groups: Group 1 (cardiopulmonary treatment), Group 2 (cardiopulmonary treatment and transcranial photobiomodulation application) and Group 3 (cardiopulmonary treatment and placebo laser). All groups will receive aerobic training on a treadmill (Moviment®) with the aid of a suspension equipment (BrainMov® Physical Activity Station). The transcranial photobiomodulation (laser diode, λ = 810 nm, beam area 0.028 cm², power of 100 mW, power density of 3.5 mW / cm², energy of 3 Joules / point and energy density of 107.1 J / cm2) will be applied on the skin / scalp and the International System 10-20 at points F7, F8 and AFz will be used as reference for irradiation. Muscular activation, heart rate variability, lung volumes and capacities, fatigability, exercise tolerance, cognition and quality of life will be evaluated before, during, at the end and after two months of rehabilitation. The treatment proposed in this study, using transcranial photobiomodulation, is expected to improve muscle, sensory, cardiorespiratory, cognitive functions and to interfere positively in the quality of life of the volunteers.

Clinical Trial Description

Central nervous system (CNS) diseases can be acquired (such as stroke, spinal cord injury, and traumatic brain injury) or non-acquired (such as multiple sclerosis). Many diseases that affect the CNS can be fatal or cause sequelae, which affect the sensorimotor, cardiorespiratory and the quality of life of the individual. Subjects with neurological lesions present low resistance to exercise, a factor that can be attributed to decreased muscle recruitment, oxidative and metabolic capacity reduction, low aerobic resistance and increased energy expenditure. With that in mind, treatment proposals such as aerobic training and gait training with or without weight loss can maximize and restore the individual's functional abilities through active learning. Cardiorespiratory fitness in this patient profile has benefits in terms of fatigue retardation, gait improvement and regulation of the autonomic nervous system. Aerobic exercises change the heart rhythm, increase vascularity and provide oxygen. The association of these factors promote cerebral neuroprotective effect, stimulate the production of endogenous neutrotransmitters related to general well-being and favor neuroplasticity. Low-intensity laser therapy, especially transcranial photobiomodulation, has shown benefits in animals and humans such as cognitive and memory improvement, improvement in the behavioral picture, such as attenuation of depression and anxiety, and cortical oxygenation.

The study design is a randomized, double-blind, placebo-controlled trial that will compare the effect of cardiorespiratory rehabilitation, cardiorespiratory rehabilitation and low-intensity laser therapy, cardiorespiratory rehabilitation and placebo laser. It is worth mentioning that the use of a Placebo Therapy is restricted to Low Power Laser irradiation. This means that the three experimental groups will effectively be treated with cardiorespiratory rehabilitation, a therapy that improves physical fitness. The treatment with transcranial photobiomodulation irradiation aims to verify the effects and aggregates greater beneficial to the volunteers. In this case, the magnitude of the laser effect must be calculated by the difference (if any) of the group treated with "cardiorespiratory rehabilitation + laser" subtracted from the group treated with "cardiorespiratory rehabilitation + laser Placebo". ;

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Headache
• Multiple Sclerosis
• Muscle Spasticity
• Post Stroke
• Post-Traumatic Headache
• Sclerosis, Multiple
• Spastic
• Spinal Injuries
• Surgery
• Trauma, Nervous System
• Wounds and Injuries

• NCT number: NCT03751306
• Study type: Interventional
• Source: Universidade do Vale do Paraíba
• Contact: Ana Paula Pinto
• Phone: 55 12 981585974
• Email: apaula@outlook.com.br
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 14, 2019
• Completion date: March 5, 2020