Aerobic Exercise and Transcranial Low Laser Therapy in Patients With Central Nervous System Injury
Sensory-Motor and Cardiorespiratory Rehabilitation Associated With Transcranial Laser Therapy in Patients With Central Nervous System Injury
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedStudy Start
First participant enrolled
January 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2020
CompletedNovember 27, 2018
November 1, 2018
7 months
November 1, 2018
November 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (18)
Change in Muscular electrical activity (Surface electromyograph).
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).
Baseline (before starting rehabilitation) and after 9 weeks.
Change in analysis of bipodal balance during the squat movement.
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).
Baseline (before starting rehabilitation) and after 9 weeks.
Change in analysis of the heart rate variability to study the responses of the autonomic nervous system
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).
Baseline (First day of rehabilitation) and after 9 weeks (Last day of rehabilitation).
Change in Pulmonary function analysis (spirometry): forced vital capacity
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.
Baseline (before starting rehabilitation) and after 9 weeks.
Change in Pulmonary function analysis (spirometry): forced expiratory volume in the first second
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.
Baseline (before starting rehabilitation) and after 9 weeks.
Change in Pulmonary function analysis (spirometry): Tiffeneau Index
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.
Baseline (before starting rehabilitation) and after 9 weeks.
Change in Pulmonary function analysis (spirometry): maximum voluntary ventilation
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).
Baseline (before starting rehabilitation) and after 9 weeks.
Change in analysis of inspiratory muscle strength
The inspiratory muscle strength will be evaluated by means of the manovacuometer.
Baseline (before starting rehabilitation) and after 9 weeks.
Analysis of expiratory muscle strength
The expiratory muscle strength will be evaluated by means of the manovacuometer
Baseline (before starting rehabilitation) and after 9 weeks.
Change in analysis of Peak expiratory flow.
To analyze the velocity of the air out of the lungs.
Baseline (before starting rehabilitation) and after 9 weeks.
Change in analysis of the thoracic expandability (axillary level).
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).
Baseline (before starting rehabilitation) and after 9 weeks.
Change in analysis of the thoracic expandability (xiphoid level).
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).
Baseline (before starting rehabilitation) and after 9 weeks.
Change in analysis of abdominal level expandability.
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).
Baseline (before starting rehabilitation) and after 9 weeks.
Change in analysis of change in Infrared Thermography.
By means of an infrared thermographic camera, the blood circulation of the lower limbs will be evaluated by the temperature difference.
Baseline (before starting rehabilitation) and after 9 weeks.
Change in aariation of blood lactate level.
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.
Baseline (before starting rehabilitation) and after 9 weeks.
Change in 6-Minute Walk Test (Adapted)
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
Baseline (before starting rehabilitation) and after 9 weeks.
Change in Mini-Mental State Examination (MINI MENTAL).
To evaluate the cognitive functions, the MINI MENTAL test will be applied.
Baseline (before starting rehabilitation) and after 9 weeks.
Change in Short Form 36 questionnaire (SF-36)
To evaluate the domains of quality of life: Functional Capacity, physical aspect, pain, general health, vitality, social aspect, emotional spectrum and mental health
Baseline (before starting rehabilitation) and after 9 week.
Secondary Outcomes (18)
Follow-up: Evaluation Muscular electrical activity (Surface electromyograph)
The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of bipodal balance during the squat movement
The follow-up revaluation will be 2 months after the end of rehabilitation.
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.
Follow-up: Pulmonary function analysis (spirometry): forced vital capacity
The follow-up revaluation will be 2 months after the end of rehabilitation.
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.
- +13 more secondary outcomes
Study Arms (3)
Control-Cardiorespiratory Rehabilitation
ACTIVE COMPARATORThese individuals will compose the control group for transcranial laser therapy, which will only receive cardiorespiratory rehabilitation.
Transcranial Photobiomodulation Placebo
PLACEBO COMPARATORIn 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
EXPERIMENTALIn this group, low-intensity irradiation will be applied and after irradiation, the volunteers will begin cardiorespiratory rehabilitation.
Interventions
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) .
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade do Vale do Paraíba
São José dos Campos, São Paulo, 12244-000, Brazil
Related Publications (1)
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.
PMID: 31232920DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mário Oliveira Lima, Doctor
Universidade do Vale do Paraíba - Univap
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2018
First Posted
November 23, 2018
Study Start
January 14, 2019
Primary Completion
July 31, 2019
Study Completion
March 5, 2020
Last Updated
November 27, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share