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

Not Applicable

• Conditions: Sclerosis, Multiple; Post-Traumatic Headache; Cerebral Palsy, Spastic; Surgery; Post Stroke; Spinal Injuries; Spastic
• Interventions: Procedure: Transcranial Photobiomodulation (Placebo); Procedure: Transcranial Photobiomodulation; Procedure: Cardiorespiratory Rehabilitation

• Registration Number: NCT03751306
• Lead Sponsor: Universidade do Vale do Paraíba

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".

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-19
• Last Update Submitted: 2018-11-22
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-27
• Study Start: 2019-01-14
• Primary Completion: 2019-07-31
• Study Completion: 2020-03-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Transcranial Photobiomodulation	Cardiorespiratory Rehabilitation	In this group, low-intensity irradiation will be applied and after irradiation, the volunteers will begin cardiorespiratory rehabilitation.
Control-Cardiorespiratory Rehabilitation	Cardiorespiratory Rehabilitation	These individuals will compose the control group for transcranial laser therapy, which will only receive cardiorespiratory rehabilitation.
Transcranial Photobiomodulation Placebo	Cardiorespiratory Rehabilitation	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.
Transcranial Photobiomodulation Placebo	Transcranial Photobiomodulation (Placebo)	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.
Transcranial Photobiomodulation	Transcranial Photobiomodulation	In this group, low-intensity irradiation will be applied and after irradiation, the volunteers will begin cardiorespiratory rehabilitation.

Primary Outcome Measures

Name	Time	Method
Change in analysis of the thoracic expandability (axillary level).	Baseline (before starting rehabilitation) and after 9 weeks.	In order to analyze the chest expansion at the axillary level, a metric tape placed at the torarico-axillary level will be used, which will measure the inspiratory and expiration mobility values, and will be subtracted (Insp-Exp).
Change in analysis of the heart rate variability to study the responses of the autonomic nervous system	Baseline (First day of rehabilitation) and after 9 weeks (Last day of rehabilitation).	Heart rate variability will be assessed during aerobic training on the treadmill for 40 minutes (5 minutes of initial rest, 30 minutes of exercise and 5 minutes of final rest).
Change in Pulmonary function analysis (spirometry): maximum voluntary ventilation	Baseline (before starting rehabilitation) and after 9 weeks.	Using the spirometry technique, maximum voluntary ventilation will be evaluated. Maximum voluntary ventilation is the largest volume of air that the individual can mobilize in one minute with maximum voluntary effort. The test gives an overview of the ventilatory function (measured in L / min).
Change in analysis of bipodal balance during the squat movement.	Baseline (before starting rehabilitation) and after 9 weeks.	The balance evaluation will be performed during the squat movement on the power platform (Stabilometric analysis in Kgf). 10 seconds of signal collection (in triplicate).
Change in Pulmonary function analysis (spirometry): Tiffeneau Index	Baseline (before starting rehabilitation) and after 9 weeks.	Using the spirometry technique, Tiffeneau Index will be evaluated. The Tiffeneau index is the result of the division of forced expiratory volume in the first second in relation to forced vital capacity.
Change in analysis of Peak expiratory flow.	Baseline (before starting rehabilitation) and after 9 weeks.	To analyze the velocity of the air out of the lungs.
Change in analysis of change in Infrared Thermography.	Baseline (before starting rehabilitation) and after 9 weeks.	By means of an infrared thermographic camera, the blood circulation of the lower limbs will be evaluated by the temperature difference.
Change in 6-Minute Walk Test (Adapted)	Baseline (before starting rehabilitation) and after 9 weeks.	The 6-minute-walk test will be adapted for neurological patients, which will be evaluated for exercise tolerance using a treadmill (Moviment RT200®). Volunteers will be assisted by the BrainMov® Rehabilitation and Physical Activity Station to stabilize the trunk and thus remain upright to wander on the treadmill
Analysis of expiratory muscle strength	Baseline (before starting rehabilitation) and after 9 weeks.	The expiratory muscle strength will be evaluated by means of the manovacuometer
Change in analysis of the thoracic expandability (xiphoid level).	Baseline (before starting rehabilitation) and after 9 weeks.	In order to analyze the chest expansion at the xiphoid level, a metric tape will be used, placed at the thoracic-xiphoid level, which will measure the inspiratory and expiration mobility values and then be subtracted (Insp-Exp).
Change in aariation of blood lactate level.	Baseline (before starting rehabilitation) and after 9 weeks.	The blood lactate level will be measured by a lactometer, which will be collected from the volunteer's blood sample before starting the aerobic training on the treadmill and after training.
Change in Muscular electrical activity (Surface electromyograph).	Baseline (before starting rehabilitation) and after 9 weeks.	The surface electrodes will be positioned in the rectus femoris and femoral biceps muscles. The evaluation of the muscles will be realized during the squat movement. 10 seconds of signal collection (in triplicate).
Change in Pulmonary function analysis (spirometry): forced vital capacity	Baseline (before starting rehabilitation) and after 9 weeks.	Using the spirometry technique, forced vital capacity (measured in liters) will be evaluated. The volunteer will be asked to perform the maximum inspiration and exhale with maximum effort.
Change in Pulmonary function analysis (spirometry): forced expiratory volume in the first second	Baseline (before starting rehabilitation) and after 9 weeks.	Using the spirometry technique, forced expiratory volume in the first second (measured in liters) will be evaluated. The volume of exhaled air in the first second in the forced vital capacity maneuver will be evaluated.
Change in analysis of abdominal level expandability.	Baseline (before starting rehabilitation) and after 9 weeks.	In order to analyze abdominal expansibility, a tape measure will be used, placed at the level of the umbilical scar, which will measure the inspiratory and expiration mobility values and will be subtracted (Insp-Exp).
Change in Mini-Mental State Examination (MINI MENTAL).	Baseline (before starting rehabilitation) and after 9 weeks.	To evaluate the cognitive functions, the MINI MENTAL test will be applied.
Change in analysis of inspiratory muscle strength	Baseline (before starting rehabilitation) and after 9 weeks.	The inspiratory muscle strength will be evaluated by means of the manovacuometer.
Change in Short Form 36 questionnaire (SF-36)	Baseline (before starting rehabilitation) and after 9 week.	To evaluate the domains of quality of life: Functional Capacity, physical aspect, pain, general health, vitality, social aspect, emotional spectrum and mental health

Secondary Outcome Measures

Name	Time	Method
Follow-up: Analysis of inspiratory muscle strength	The follow-up revaluation will be 2 months after the end of rehabilitation.	The inspiratory muscle strength will be evaluated by means of the manovacuometer.
Follow-up: Analysis of Peak expiratory flow.	The follow-up revaluation will be 2 months after the end of rehabilitation.	To analyze the velocity of the air out of the lungs.
Follow-up: Pulmonary function analysis (spirometry): forced expiratory volume in the first second	The follow-up revaluation will be 2 months after the end of rehabilitation.	Using the spirometry technique, forced expiratory volume in the first second (measured in liters) will be evaluated. The volume of exhaled air in the first second in the forced vital capacity maneuver will be evaluated.
Follow-up: Evaluation Mini-Mental State Examination (MINI MENTAL).	The follow-up revaluation will be 2 months after the end of rehabilitation.	To evaluate the cognitive functions, the MINI MENTAL test will be applied.
Follow-up: Analysis of bipodal balance during the squat movement	The follow-up revaluation will be 2 months after the end of rehabilitation.	The balance evaluation will be performed during the squat movement on the power platform. 10 seconds of signal collection (in triplicate).
Follow-up: Pulmonary function analysis (spirometry): forced vital capacity	The follow-up revaluation will be 2 months after the end of rehabilitation.	Using the spirometry technique, forced vital capacity (measured in liters) will be evaluated. The patient will be asked to perform the maximum inspiration and exhale with maximum effort.
Follow-up: Analysis of the thoracic expandability (axillary level).	The follow-up revaluation will be 2 months after the end of rehabilitation.	In order to analyze the chest expansion at the axillary level, a metric tape placed at the torarico-axillary level will be used, which will measure the inspiratory and expiration mobility values, and will be subtracted (Insp-Exp).
Follow-up: Analysis of the thoracic expandability (xiphoid level).	The follow-up revaluation will be 2 months after the end of rehabilitation.	In order to analyze the chest expansion at the xiphoid level, a metric tape will be used, placed at the thoracic-xiphoid level, which will measure the inspiratory and expiration mobility values and then be subtracted (Insp-Exp).
Follow-up: Analysis of change in Infrared Thermography.	The follow-up revaluation will be 2 months after the end of rehabilitation.	By means of an infrared thermographic camera, the blood circulation of the lower limbs will be evaluated by the temperature difference.
Follow-up: Pulmonary function analysis (spirometry):Tiffeneau Index	The follow-up revaluation will be 2 months after the end of rehabilitation.	Using the spirometry technique, Tiffeneau Index will be evaluated. The Tiffeneau index is the result of the division of forced expiratory volume in the first second in relation to forced vital capacity.
Follow-up: Analysis of expiratory muscle strength	The follow-up revaluation will be 2 months after the end of rehabilitation.	The expiratory muscle strength will be evaluated by means of the manovacuometer.
Follow-up: Evaluation Muscular electrical activity (Surface electromyograph)	The follow-up revaluation will be 2 months after the end of rehabilitation.	Evaluation of muscular electrical activity after 9 weeks of the end of rehabilitation. The surface electrodes will be positioned in the rectus femoris and femoral biceps muscles. The evaluation of the muscles will be realized during the squat movement. 10 seconds of signal collection (in triplicate).
Follow-up: Analysis of abdominal level expandability.	The follow-up revaluation will be 2 months after the end of rehabilitation.	In order to analyze abdominal expansibility, a tape measure will be used, placed at the level of the umbilical scar, which will measure the inspiratory and expiration mobility values and will be subtracted (Insp-Exp).
Follow-up: Analysis 6-Minute Walk Test (Adapted)	The follow-up revaluation will be 2 months after the end of rehabilitation.	The 6-minute-walk test will be adapted for neurological patients, which will be evaluated for exercise tolerance using a treadmill (Moviment RT200®). Volunteers will be assisted by the BrainMov® Rehabilitation and Physical Activity Station to stabilize the trunk and thus remain upright to wander on the treadmill.
Follow-up: Analysis of the heart rate variability to study the responses of the autonomic nervous system	The follow-up revaluation will be 2 months after the end of rehabilitation.	The heart rate variability will be evaluated during aerobic training on the treadmill using a frequency for 5 minutes of initial rest, 30 minutes of exercise and 5 minutes of final rest.
Follow-up: Pulmonary function analysis (spirometry): maximum voluntary ventilation	The follow-up revaluation will be 2 months after the end of rehabilitation.	Using the spirometry technique, maximum voluntary ventilation will be evaluated. Maximum voluntary ventilation is the largest volume of air that the individual can mobilize in one minute with maximum voluntary effort. The test gives an overview of the ventilatory function (measured in L / min).
Follow-up: Variation of blood lactate level.	The follow-up revaluation will be 2 months after the end of rehabilitation.	The blood lactate level will be measured by a lactometer, which will be collected from the volunteer's blood sample before starting the aerobic training on the treadmill and after training.
Follow-up: Evaluation Short Form 36 questionnaire (SF-36)	The follow-up revaluation will be 2 months after the end of rehabilitation.	To evaluate the domains of quality of life: Functional Capacity, physical aspect, pain, general health, vitality, social aspect, emotional spectrum and mental health

Trial Locations

Locations (1)

Universidade do Vale do Paraíba; 🇧🇷 São José Dos Campos, São Paulo, Brazil