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

Universidade do Vale do Paraíba

Status: Unknown

Conditions: Cerebral Palsy, Spastic; Spastic; Spinal Injuries; Surgery; Post-Traumatic Headache; Sclerosis, Multiple; Post Stroke

Treatments: Procedure: Transcranial Photobiomodulation; Procedure: Cardiorespiratory Rehabilitation; Procedure: Transcranial Photobiomodulation (Placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT03751306

94858718.3.0000.5503

Details and patient eligibility

About

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.

Full 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".

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Persons with stroke, traumatic brain injury, spinal cord trauma, post-operative brain tumor, chronic non-progressive encephalopathy and multiple sclerosis;
• Chronic neurological diseases, from 6 months of injury;
• Caucasian individuals;
• Age between 18 and 85 years;
• Both sexes;
• Individuals with the cognitive preserved;
• Persons who are able to wander on the treadmill voluntarily or through assistance from the Rehabilitation and Physical Activity Station BrainMov®;
• Persons who make continuous and regular use of medications prescribed by the physician for the control and / or treatment of chronic diseases;
• People with the release of the cardiologist for rehabilitation.

Exclusion criteria

• People who do not meet the inclusion criteria;
• Active smokers;
• Carriers of chronic respiratory diseases, such as COPD, asthma and bronchiectasis;
• Patients with decompensated heart disease;
• Obesity grade II - body mass index greater than 34.99 kg / m2;
• Patients with spinal cord injury above T6, who present autonomic dysreflexia;
• Patients with ASA A or B spinal cord injury;
• Patients with multiple sclerosis who are in an outbreak period;
• Patients taking betablockers;
• Hemorrhagic stroke.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Control-Cardiorespiratory Rehabilitation

Active Comparator group

Description:

These individuals will compose the control group for transcranial laser therapy, which will only receive cardiorespiratory rehabilitation.

Treatment:

Procedure: Cardiorespiratory Rehabilitation

Transcranial Photobiomodulation Placebo

Placebo Comparator group

Description:

In this group, the application of laser irradiation will be simulated, and the laser will be turned off. And the simulation of irradiation, the individuals will initiate cardiorespiratory rehabilitation.

Treatment:

Procedure: Cardiorespiratory Rehabilitation

Procedure: Transcranial Photobiomodulation (Placebo)

Transcranial Photobiomodulation

Experimental group

Description:

In this group, low-intensity irradiation will be applied and after irradiation, the volunteers will begin cardiorespiratory rehabilitation.

Treatment:

Procedure: Cardiorespiratory Rehabilitation

Procedure: Transcranial Photobiomodulation