<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03751306</url>
  </required_header>
  <id_info>
    <org_study_id>94858718.3.0000.5503</org_study_id>
    <nct_id>NCT03751306</nct_id>
  </id_info>
  <brief_title>Aerobic Exercise and Transcranial Low Laser Therapy in Patients With Central Nervous System Injury</brief_title>
  <official_title>Sensory-Motor and Cardiorespiratory Rehabilitation Associated With Transcranial Laser Therapy in Patients With Central Nervous System Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade do Vale do Paraíba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade do Vale do Paraíba</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective of this protocol will be to evaluate the parameters related to the function of the&#xD;
      musculoskeletal and cardiorespiratory system, through a rehabilitation and training program&#xD;
      for people with acquired central nervous system and multiple sclerosis. The study will&#xD;
      consist of volunteers with acquired CNS lesions and multiple sclerosis of both sexes, between&#xD;
      18 and 85 years old, and who wander with or without aid devices, randomly divided into 3&#xD;
      groups: Group 1 (cardiopulmonary treatment), Group 2 (cardiopulmonary treatment and&#xD;
      transcranial photobiomodulation application) and Group 3 (cardiopulmonary treatment and&#xD;
      placebo laser). All groups will receive aerobic training on a treadmill (Moviment®) with the&#xD;
      aid of a suspension equipment (BrainMov® Physical Activity Station). The transcranial&#xD;
      photobiomodulation (laser diode, λ = 810 nm, beam area 0.028 cm², power of 100 mW, power&#xD;
      density of 3.5 mW / cm², energy of 3 Joules / point and energy density of 107.1 J / cm2) will&#xD;
      be applied on the skin / scalp and the International System 10-20 at points F7, F8 and AFz&#xD;
      will be used as reference for irradiation. Muscular activation, heart rate variability, lung&#xD;
      volumes and capacities, fatigability, exercise tolerance, cognition and quality of life will&#xD;
      be evaluated before, during, at the end and after two months of rehabilitation. The treatment&#xD;
      proposed in this study, using transcranial photobiomodulation, is expected to improve muscle,&#xD;
      sensory, cardiorespiratory, cognitive functions and to interfere positively in the quality of&#xD;
      life of the volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Central nervous system (CNS) diseases can be acquired (such as stroke, spinal cord injury,&#xD;
      and traumatic brain injury) or non-acquired (such as multiple sclerosis). Many diseases that&#xD;
      affect the CNS can be fatal or cause sequelae, which affect the sensorimotor,&#xD;
      cardiorespiratory and the quality of life of the individual. Subjects with neurological&#xD;
      lesions present low resistance to exercise, a factor that can be attributed to decreased&#xD;
      muscle recruitment, oxidative and metabolic capacity reduction, low aerobic resistance and&#xD;
      increased energy expenditure. With that in mind, treatment proposals such as aerobic training&#xD;
      and gait training with or without weight loss can maximize and restore the individual's&#xD;
      functional abilities through active learning. Cardiorespiratory fitness in this patient&#xD;
      profile has benefits in terms of fatigue retardation, gait improvement and regulation of the&#xD;
      autonomic nervous system. Aerobic exercises change the heart rhythm, increase vascularity and&#xD;
      provide oxygen. The association of these factors promote cerebral neuroprotective effect,&#xD;
      stimulate the production of endogenous neutrotransmitters related to general well-being and&#xD;
      favor neuroplasticity. Low-intensity laser therapy, especially transcranial&#xD;
      photobiomodulation, has shown benefits in animals and humans such as cognitive and memory&#xD;
      improvement, improvement in the behavioral picture, such as attenuation of depression and&#xD;
      anxiety, and cortical oxygenation.&#xD;
&#xD;
      The study design is a randomized, double-blind, placebo-controlled trial that will compare&#xD;
      the effect of cardiorespiratory rehabilitation, cardiorespiratory rehabilitation and&#xD;
      low-intensity laser therapy, cardiorespiratory rehabilitation and placebo laser. It is worth&#xD;
      mentioning that the use of a Placebo Therapy is restricted to Low Power Laser irradiation.&#xD;
      This means that the three experimental groups will effectively be treated with&#xD;
      cardiorespiratory rehabilitation, a therapy that improves physical fitness. The treatment&#xD;
      with transcranial photobiomodulation irradiation aims to verify the effects and aggregates&#xD;
      greater beneficial to the volunteers. In this case, the magnitude of the laser effect must be&#xD;
      calculated by the difference (if any) of the group treated with &quot;cardiorespiratory&#xD;
      rehabilitation + laser&quot; subtracted from the group treated with &quot;cardiorespiratory&#xD;
      rehabilitation + laser Placebo&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 14, 2019</start_date>
  <completion_date type="Anticipated">March 5, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Muscular electrical activity (Surface electromyograph).</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in analysis of bipodal balance during the squat movement.</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in analysis of the heart rate variability to study the responses of the autonomic nervous system</measure>
    <time_frame>Baseline (First day of rehabilitation) and after 9 weeks (Last day of rehabilitation).</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Pulmonary function analysis (spirometry): forced vital capacity</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Pulmonary function analysis (spirometry): forced expiratory volume in the first second</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Pulmonary function analysis (spirometry): Tiffeneau Index</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Pulmonary function analysis (spirometry): maximum voluntary ventilation</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in analysis of inspiratory muscle strength</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>The inspiratory muscle strength will be evaluated by means of the manovacuometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of expiratory muscle strength</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>The expiratory muscle strength will be evaluated by means of the manovacuometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in analysis of Peak expiratory flow.</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>To analyze the velocity of the air out of the lungs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in analysis of the thoracic expandability (axillary level).</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in analysis of the thoracic expandability (xiphoid level).</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in analysis of abdominal level expandability.</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in analysis of change in Infrared Thermography.</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>By means of an infrared thermographic camera, the blood circulation of the lower limbs will be evaluated by the temperature difference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in aariation of blood lactate level.</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in 6-Minute Walk Test (Adapted)</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mini-Mental State Examination (MINI MENTAL).</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 weeks.</time_frame>
    <description>To evaluate the cognitive functions, the MINI MENTAL test will be applied.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Short Form 36 questionnaire (SF-36)</measure>
    <time_frame>Baseline (before starting rehabilitation) and after 9 week.</time_frame>
    <description>To evaluate the domains of quality of life: Functional Capacity, physical aspect, pain, general health, vitality, social aspect, emotional spectrum and mental health</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Evaluation Muscular electrical activity (Surface electromyograph)</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Analysis of bipodal balance during the squat movement</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>The balance evaluation will be performed during the squat movement on the power platform. 10 seconds of signal collection (in triplicate).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Analysis of the heart rate variability to study the responses of the autonomic nervous system</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Pulmonary function analysis (spirometry): forced vital capacity</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Pulmonary function analysis (spirometry): forced expiratory volume in the first second</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Pulmonary function analysis (spirometry):Tiffeneau Index</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Pulmonary function analysis (spirometry): maximum voluntary ventilation</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Analysis of inspiratory muscle strength</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>The inspiratory muscle strength will be evaluated by means of the manovacuometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Analysis of expiratory muscle strength</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>The expiratory muscle strength will be evaluated by means of the manovacuometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Analysis of Peak expiratory flow.</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>To analyze the velocity of the air out of the lungs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Analysis of the thoracic expandability (axillary level).</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Analysis of the thoracic expandability (xiphoid level).</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Analysis of abdominal level expandability.</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Analysis of change in Infrared Thermography.</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>By means of an infrared thermographic camera, the blood circulation of the lower limbs will be evaluated by the temperature difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Variation of blood lactate level.</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Analysis 6-Minute Walk Test (Adapted)</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Evaluation Mini-Mental State Examination (MINI MENTAL).</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>To evaluate the cognitive functions, the MINI MENTAL test will be applied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up: Evaluation Short Form 36 questionnaire (SF-36)</measure>
    <time_frame>The follow-up revaluation will be 2 months after the end of rehabilitation.</time_frame>
    <description>To evaluate the domains of quality of life: Functional Capacity, physical aspect, pain, general health, vitality, social aspect, emotional spectrum and mental health</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Post Stroke</condition>
  <condition>Post-Traumatic Headache</condition>
  <condition>Spinal Injuries</condition>
  <condition>Cerebral Palsy, Spastic</condition>
  <condition>Surgery</condition>
  <condition>Sclerosis, Multiple</condition>
  <condition>Spastic</condition>
  <arm_group>
    <arm_group_label>Control-Cardiorespiratory Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These individuals will compose the control group for transcranial laser therapy, which will only receive cardiorespiratory rehabilitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transcranial Photobiomodulation Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transcranial Photobiomodulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, low-intensity irradiation will be applied and after irradiation, the volunteers will begin cardiorespiratory rehabilitation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transcranial Photobiomodulation</intervention_name>
    <description>Photobiomodulation Rehabilitation:&#xD;
Diode laser, λ infrared = 810 nm, 0.028 cm2 beam area, 100 mW power, 3.5 W / cm2 power density, 3 Joules / dot and Energy Density of 107.1 J / cm2). Each point will be radiated for 30 seconds. The regions of irradiation will be in the middle cerebral arteries (points F7 and F8 will be used as reference point according to the International System 10-20 of the electroencephalogram) and anterior cerebral artery (AFz point according to the International System 10-20 of the electroencephalogram) .</description>
    <arm_group_label>Transcranial Photobiomodulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transcranial Photobiomodulation (Placebo)</intervention_name>
    <description>Photobiomodulation Placebo Therapy:&#xD;
The same apparatus of the transcranial group photobiomodulation and the same irradiation points will be used. However, during the procedure, with the laser off.</description>
    <arm_group_label>Transcranial Photobiomodulation Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardiorespiratory Rehabilitation</intervention_name>
    <description>Cardiorespiratory Rehabilitation:&#xD;
Aerobic training on the treadmill will be reliated for 30 minutes using the support of the Rehabilitation and Physical Activity Station BrainMov® (equipment with 4 pillars condition that favors the suspension and stabilization of people with neuromuscular dysfunctions of mild to severe impairment. For monitoring, the training heart rate equation - Karvonen equation, effort perception scale - BORG, systemic arterial pressure, peripheral oxygen saturation, and patient signs and symptoms will be used. Subsequently, respiratory exercises and muscle strengthening of lower limbs, final relaxation and general guidelines will be performed for research volunteer and his / her relatives.</description>
    <arm_group_label>Control-Cardiorespiratory Rehabilitation</arm_group_label>
    <arm_group_label>Transcranial Photobiomodulation</arm_group_label>
    <arm_group_label>Transcranial Photobiomodulation Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons with stroke, traumatic brain injury, spinal cord trauma, post-operative brain&#xD;
             tumor, chronic non-progressive encephalopathy and multiple sclerosis;&#xD;
&#xD;
          -  Chronic neurological diseases, from 6 months of injury;&#xD;
&#xD;
          -  Caucasian individuals;&#xD;
&#xD;
          -  Age between 18 and 85 years;&#xD;
&#xD;
          -  Both sexes;&#xD;
&#xD;
          -  Individuals with the cognitive preserved;&#xD;
&#xD;
          -  Persons who are able to wander on the treadmill voluntarily or through assistance from&#xD;
             the Rehabilitation and Physical Activity Station BrainMov®;&#xD;
&#xD;
          -  Persons who make continuous and regular use of medications prescribed by the physician&#xD;
             for the control and / or treatment of chronic diseases;&#xD;
&#xD;
          -  People with the release of the cardiologist for rehabilitation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People who do not meet the inclusion criteria;&#xD;
&#xD;
          -  Active smokers;&#xD;
&#xD;
          -  Carriers of chronic respiratory diseases, such as COPD, asthma and bronchiectasis;&#xD;
&#xD;
          -  Patients with decompensated heart disease;&#xD;
&#xD;
          -  Obesity grade II - body mass index greater than 34.99 kg / m2;&#xD;
&#xD;
          -  Patients with spinal cord injury above T6, who present autonomic dysreflexia;&#xD;
&#xD;
          -  Patients with ASA A or B spinal cord injury;&#xD;
&#xD;
          -  Patients with multiple sclerosis who are in an outbreak period;&#xD;
&#xD;
          -  Patients taking betablockers;&#xD;
&#xD;
          -  Hemorrhagic stroke.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mário Oliveira Lima, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade do Vale do Paraíba - Univap</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ana Paula Pinto</last_name>
    <phone>55 12 981585974</phone>
    <email>apaula@outlook.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carolina Lobo Guimarães</last_name>
    <phone>55 12 981585974</phone>
    <email>caroll.guimaraes@yahoo.com.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universidade do Vale do Paraíba</name>
      <address>
        <city>São José Dos Campos</city>
        <state>São Paulo</state>
        <zip>12244-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Ana Paula Pinto</last_name>
      <phone>55 12 981585974</phone>
      <email>apaula@outlook.com.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 1, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 22, 2018</last_update_submitted>
  <last_update_submitted_qc>November 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neurological Diseases</keyword>
  <keyword>Cardiorespiratory Rehabilitation</keyword>
  <keyword>Aerobic exercise</keyword>
  <keyword>Fotobiomodulação Transcraniana</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Post-Traumatic Headache</mesh_term>
    <mesh_term>Trauma, Nervous System</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Headache</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Spinal Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03751306
org study id: 94858718.3.0000.5503
nct id: NCT03751306
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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".
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in Muscular electrical activity (Surface electromyograph).
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: 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).
measure: Change in analysis of bipodal balance during the squat movement.
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: 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).
measure: Change in analysis of the heart rate variability to study the responses of the autonomic nervous system
time frame: Baseline (First day of rehabilitation) and after 9 weeks (Last day of rehabilitation).
description: 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).
measure: Change in Pulmonary function analysis (spirometry): forced vital capacity
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: 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.
measure: Change in Pulmonary function analysis (spirometry): forced expiratory volume in the first second
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: 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.
measure: Change in Pulmonary function analysis (spirometry): Tiffeneau Index
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: 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.
measure: Change in Pulmonary function analysis (spirometry): maximum voluntary ventilation
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: 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).
measure: Change in analysis of inspiratory muscle strength
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: The inspiratory muscle strength will be evaluated by means of the manovacuometer.
measure: Analysis of expiratory muscle strength
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: The expiratory muscle strength will be evaluated by means of the manovacuometer
measure: Change in analysis of Peak expiratory flow.
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: To analyze the velocity of the air out of the lungs.
measure: Change in analysis of the thoracic expandability (axillary level).
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: 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).
measure: Change in analysis of the thoracic expandability (xiphoid level).
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: 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).
measure: Change in analysis of abdominal level expandability.
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: 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).
measure: Change in analysis of change in Infrared Thermography.
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: By means of an infrared thermographic camera, the blood circulation of the lower limbs will be evaluated by the temperature difference.
measure: Change in aariation of blood lactate level.
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: 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.
measure: Change in 6-Minute Walk Test (Adapted)
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: 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
measure: Change in Mini-Mental State Examination (MINI MENTAL).
time frame: Baseline (before starting rehabilitation) and after 9 weeks.
description: To evaluate the cognitive functions, the MINI MENTAL test will be applied.
measure: Change in Short Form 36 questionnaire (SF-36)
time frame: Baseline (before starting rehabilitation) and after 9 week.
description: To evaluate the domains of quality of life: Functional Capacity, physical aspect, pain, general health, vitality, social aspect, emotional spectrum and mental health
measure: Follow-up: Evaluation Muscular electrical activity (Surface electromyograph)
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: 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).
measure: Follow-up: Analysis of bipodal balance during the squat movement
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: The balance evaluation will be performed during the squat movement on the power platform. 10 seconds of signal collection (in triplicate).
measure: Follow-up: Analysis of the heart rate variability to study the responses of the autonomic nervous system
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: 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.
measure: Follow-up: Pulmonary function analysis (spirometry): forced vital capacity
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: 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.
measure: Follow-up: Pulmonary function analysis (spirometry): forced expiratory volume in the first second
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: 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.
measure: Follow-up: Pulmonary function analysis (spirometry):Tiffeneau Index
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: 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.
measure: Follow-up: Pulmonary function analysis (spirometry): maximum voluntary ventilation
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: 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).
measure: Follow-up: Analysis of inspiratory muscle strength
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: The inspiratory muscle strength will be evaluated by means of the manovacuometer.
measure: Follow-up: Analysis of expiratory muscle strength
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: The expiratory muscle strength will be evaluated by means of the manovacuometer.
measure: Follow-up: Analysis of Peak expiratory flow.
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: To analyze the velocity of the air out of the lungs.
measure: Follow-up: Analysis of the thoracic expandability (axillary level).
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: 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).
measure: Follow-up: Analysis of the thoracic expandability (xiphoid level).
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: 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).
measure: Follow-up: Analysis of abdominal level expandability.
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: 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).
measure: Follow-up: Analysis of change in Infrared Thermography.
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: By means of an infrared thermographic camera, the blood circulation of the lower limbs will be evaluated by the temperature difference.
measure: Follow-up: Variation of blood lactate level.
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: 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.
measure: Follow-up: Analysis 6-Minute Walk Test (Adapted)
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: 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.
measure: Follow-up: Evaluation Mini-Mental State Examination (MINI MENTAL).
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: To evaluate the cognitive functions, the MINI MENTAL test will be applied.
measure: Follow-up: Evaluation Short Form 36 questionnaire (SF-36)
time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
description: To evaluate the domains of quality of life: Functional Capacity, physical aspect, pain, general health, vitality, social aspect, emotional spectrum and mental health
arm group label: Control-Cardiorespiratory Rehabilitation
arm group type: Active Comparator
description: These individuals will compose the control group for transcranial laser therapy, which will only receive cardiorespiratory rehabilitation.
arm group label: Transcranial Photobiomodulation Placebo
arm group type: Placebo Comparator
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.
arm group label: Transcranial Photobiomodulation
arm group type: Experimental
description: In this group, low-intensity irradiation will be applied and after irradiation, the volunteers will begin cardiorespiratory rehabilitation.
intervention type: Procedure
intervention name: Transcranial Photobiomodulation
description: Photobiomodulation Rehabilitation:
Diode laser, λ infrared = 810 nm, 0.028 cm2 beam area, 100 mW power, 3.5 W / cm2 power density, 3 Joules / dot and Energy Density of 107.1 J / cm2). Each point will be radiated for 30 seconds. The regions of irradiation will be in the middle cerebral arteries (points F7 and F8 will be used as reference point according to the International System 10-20 of the electroencephalogram) and anterior cerebral artery (AFz point according to the International System 10-20 of the electroencephalogram) .
arm group label: Transcranial Photobiomodulation
intervention type: Procedure
intervention name: Transcranial Photobiomodulation (Placebo)
description: Photobiomodulation Placebo Therapy:
The same apparatus of the transcranial group photobiomodulation and the same irradiation points will be used. However, during the procedure, with the laser off.
arm group label: Transcranial Photobiomodulation Placebo
intervention type: Procedure
intervention name: Cardiorespiratory Rehabilitation
description: Cardiorespiratory Rehabilitation:
Aerobic training on the treadmill will be reliated for 30 minutes using the support of the Rehabilitation and Physical Activity Station BrainMov® (equipment with 4 pillars condition that favors the suspension and stabilization of people with neuromuscular dysfunctions of mild to severe impairment. For monitoring, the training heart rate equation - Karvonen equation, effort perception scale - BORG, systemic arterial pressure, peripheral oxygen saturation, and patient signs and symptoms will be used. Subsequently, respiratory exercises and muscle strengthening of lower limbs, final relaxation and general guidelines will be performed for research volunteer and his / her relatives.
arm group label: Control-Cardiorespiratory Rehabilitation
arm group label: Transcranial Photobiomodulation
arm group label: Transcranial Photobiomodulation Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Mário Oliveira Lima, Doctor
role: Principal Investigator
affiliation: Universidade do Vale do Paraíba - Univap
last name: Ana Paula Pinto
phone: 55 12 981585974
email: apaula@outlook.com.br
last name: Carolina Lobo Guimarães
phone: 55 12 981585974
email: caroll.guimaraes@yahoo.com.br
facility: 
contact: 
country: Brazil
responsible party type: Sponsor
mesh term: Muscle Spasticity
mesh term: Cerebral Palsy
mesh term: Post-Traumatic Headache
mesh term: Trauma, Nervous System
mesh term: Multiple Sclerosis
mesh term: Headache
mesh term: Wounds and Injuries
mesh term: Spinal Injuries
sharing ipd: No