Clinical trial NCT03751306: Aerobic Exercise and Transcranial Low Laser Therapy in Patients With Central Nervous System Injury
Official title: Sensory-Motor and Cardiorespiratory Rehabilitation Associated With Transcranial Laser Therapy in Patients With Central Nervous System Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Stroke
Post-Traumatic Headache
Spinal Injuries
Cerebral Palsy, Spastic
Surgery
Sclerosis, Multiple
Spastic
Keywords: Neurological Diseases
Cardiorespiratory Rehabilitation
Aerobic exercise
Fotobiomodulação Transcraniana
Lead sponsor: Universidade do Vale do Paraíba
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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".

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Muscular electrical activity (Surface electromyograph).
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in analysis of bipodal balance during the squat movement.
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in analysis of the heart rate variability to study the responses of the autonomic nervous system
timeFrame: Baseline (First day of rehabilitation) and after 9 weeks (Last day of rehabilitation).
measure: Change in Pulmonary function analysis (spirometry): forced vital capacity
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in Pulmonary function analysis (spirometry): forced expiratory volume in the first second
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in Pulmonary function analysis (spirometry): Tiffeneau Index
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in Pulmonary function analysis (spirometry): maximum voluntary ventilation
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in analysis of inspiratory muscle strength
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Analysis of expiratory muscle strength
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in analysis of Peak expiratory flow.
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in analysis of the thoracic expandability (axillary level).
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in analysis of the thoracic expandability (xiphoid level).
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in analysis of abdominal level expandability.
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in analysis of change in Infrared Thermography.
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in aariation of blood lactate level.
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in 6-Minute Walk Test (Adapted)
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in Mini-Mental State Examination (MINI MENTAL).
timeFrame: Baseline (before starting rehabilitation) and after 9 weeks.
measure: Change in Short Form 36 questionnaire (SF-36)
timeFrame: Baseline (before starting rehabilitation) and after 9 week.
Secondary outcomes:
measure: Follow-up: Evaluation Muscular electrical activity (Surface electromyograph)
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Analysis of bipodal balance during the squat movement
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Analysis of the heart rate variability to study the responses of the autonomic nervous system
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Pulmonary function analysis (spirometry): forced vital capacity
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Pulmonary function analysis (spirometry): forced expiratory volume in the first second
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Pulmonary function analysis (spirometry):Tiffeneau Index
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Pulmonary function analysis (spirometry): maximum voluntary ventilation
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Analysis of inspiratory muscle strength
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Analysis of expiratory muscle strength
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Analysis of Peak expiratory flow.
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Analysis of the thoracic expandability (axillary level).
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Analysis of the thoracic expandability (xiphoid level).
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Analysis of abdominal level expandability.
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Analysis of change in Infrared Thermography.
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Variation of blood lactate level.
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Analysis 6-Minute Walk Test (Adapted)
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Evaluation Mini-Mental State Examination (MINI MENTAL).
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
measure: Follow-up: Evaluation Short Form 36 questionnaire (SF-36)
timeFrame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Other outcomes:
Locations:
city: São José Dos Campos
country: Brazil
facility: Universidade do Vale do Paraíba
state: São Paulo
Study officials:
affiliation: Universidade do Vale do Paraíba - Univap
name: Mário Oliveira Lima, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinto AP, Guimaraes CL, Souza GADS, Leonardo PS, Neves MFD, Lima FPS, Lima MO, Lopes-Martins RAB. 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. Medicine (Baltimore). 2019 Jun;98(25):e15851. doi: 10.1097/MD.0000000000015851.