Post StrokeNCT03751306
Aerobic Exercise and Transcranial Low Laser Therapy in Patients With Central Nervous System Injury
A study testing Transcranial Photobiomodulation and Cardiorespiratory Rehabilitation in people with Post Stroke and Post-Traumatic Headache, run by Universidade do Vale do Paraíba at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post Stroke, Post-Traumatic Headache, Spinal Injuries
- What is being tested?
- Transcranial Photobiomodulation and Cardiorespiratory Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Jan 2019to 5 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
Show all 10Show fewer
- Patients with ASA A or B spinal cord injury;
- Patients with multiple sclerosis who are in an outbreak period;
- Patients taking betablockers;
- Hemorrhagic stroke.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade do Vale do Paraíba
São José dos Campos, São Paulo, 12244-000
Ana Paula Pinto, 55 12 981585974, apaula@outlook.com.br
About this study
Official title: Sensory-Motor and Cardiorespiratory Rehabilitation Associated With Transcranial Laser Therapy in Patients With Central Nervous System Injury
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.
Read the 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".
- Conditions
- Post Stroke, Post-Traumatic Headache, Spinal Injuries, Cerebral Palsy, Spastic, Surgery, Sclerosis, Multiple
- Being tested
- Transcranial Photobiomodulation, Transcranial Photobiomodulation (Placebo), Cardiorespiratory Rehabilitation
- Keywords
- Neurological Diseases, Cardiorespiratory Rehabilitation, Aerobic exercise, Fotobiomodulação Transcraniana
- Medical subject headings
- Post-Traumatic Headache, Spinal Injuries, Cerebral Palsy, Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial PhotobiomodulationProcedure or surgery
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) .
Transcranial Photobiomodulation (Placebo)Procedure or surgery
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 RehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control-Cardiorespiratory Rehabilitation | Active comparator | These individuals will compose the control group for transcranial laser therapy, which will only receive cardiorespiratory rehabilitation. Receives: Procedure: Cardiorespiratory Rehabilitation |
| Transcranial Photobiomodulation Placebo | Placebo comparator | 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. Receives: Procedure: Transcranial Photobiomodulation (Placebo); Procedure: Cardiorespiratory Rehabilitation |
| Transcranial Photobiomodulation | Experimental | In this group, low-intensity irradiation will be applied and after irradiation, the volunteers will begin cardiorespiratory rehabilitation. Receives: Procedure: Transcranial Photobiomodulation; Procedure: Cardiorespiratory Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline (before starting rehabilitation) and after 9 week.
Secondary outcomes (18)
Follow-up: Evaluation Muscular electrical activity (Surface electromyograph)
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).
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of bipodal balance during the squat movement
The balance evaluation will be performed during the squat movement on the power platform. 10 seconds of signal collection (in triplicate).
Measured: 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 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.
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Pulmonary function analysis (spirometry): forced vital capacity
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.
Measured: 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
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.
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: 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.
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: 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).
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of inspiratory muscle strength
The inspiratory muscle strength will be evaluated by means of the manovacuometer.
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of expiratory muscle strength
The expiratory muscle strength will be evaluated by means of the manovacuometer.
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of Peak expiratory flow.
To analyze the velocity of the air out of the lungs.
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: 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).
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: 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).
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: 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).
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: 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.
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Variation 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.
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis 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.
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Evaluation Mini-Mental State Examination (MINI MENTAL).
To evaluate the cognitive functions, the MINI MENTAL test will be applied.
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Evaluation 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
Measured: The follow-up revaluation will be 2 months after the end of rehabilitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start14 Jan 2019 (estimated)
- Primary completion31 Jul 2019 (estimated)
- Study completion5 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mário Oliveira Lima, Doctor, Principal investigator, Universidade do Vale do Paraíba - Univap
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751306
- Sponsor's protocol ID
- 94858718.3.0000.5503
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31232920
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory-Motor and Cardiorespiratory Rehabilitation Associated With Transcranial Laser Therapy in Patients With Central Nervous System Injury
- ClinicalTrials.gov ID
- NCT03751306
- Acronym / sponsor ID
- 94858718.3.0000.5503
- Conditions
- Post Stroke, Post-Traumatic Headache, Spinal Injuries, Cerebral Palsy, Spastic, Surgery, Sclerosis, Multiple
- Keywords
- Neurological Diseases, Cardiorespiratory Rehabilitation, Aerobic exercise, Fotobiomodulação Transcraniana
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universidade do Vale do ParaíbaUniversity, hospital or other
- Study start
- 14 Jan 2019 (estimated)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 5 Mar 2020 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control-Cardiorespiratory Rehabilitation | Active comparator | Procedure: Cardiorespiratory RehabilitationThese individuals will compose the control group for transcranial laser therapy, which will only receive cardiorespiratory rehabilitation. |
| Transcranial Photobiomodulation Placebo | Placebo comparator | Procedure: Transcranial Photobiomodulation (Placebo), Procedure: Cardiorespiratory RehabilitationIn 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 | Experimental | Procedure: Transcranial Photobiomodulation, Procedure: Cardiorespiratory RehabilitationIn this group, low-intensity irradiation will be applied and after irradiation, the volunteers will begin cardiorespiratory rehabilitation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial PhotobiomodulationPhotobiomodulation 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) . | Procedure or surgery | Transcranial Photobiomodulation |
| Transcranial Photobiomodulation (Placebo)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. | Procedure or surgery | Transcranial Photobiomodulation Placebo |
| Cardiorespiratory RehabilitationCardiorespiratory 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. | Procedure or surgery | Control-Cardiorespiratory Rehabilitation, Transcranial Photobiomodulation, Transcranial Photobiomodulation Placebo |
Primary outcome
Change in Muscular electrical activity (Surface electromyograph).
Time frame: 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 analysis of bipodal balance during the squat movement.
Time frame: 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 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).
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): forced vital capacity
Time frame: 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
Time frame: 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 Pulmonary function analysis (spirometry): Tiffeneau Index
Time frame: 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 Pulmonary function analysis (spirometry): maximum voluntary ventilation
Time frame: 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 inspiratory muscle strength
Time frame: Baseline (before starting rehabilitation) and after 9 weeks.
The inspiratory muscle strength will be evaluated by means of the manovacuometer.
Analysis of expiratory muscle strength
Time frame: Baseline (before starting rehabilitation) and after 9 weeks.
The expiratory muscle strength will be evaluated by means of the manovacuometer
Change in analysis of Peak expiratory flow.
Time frame: Baseline (before starting rehabilitation) and after 9 weeks.
To analyze the velocity of the air out of the lungs.
Change in analysis of the thoracic expandability (axillary level).
Time frame: 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 thoracic expandability (xiphoid level).
Time frame: 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 analysis of abdominal level expandability.
Time frame: 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 analysis of change in Infrared Thermography.
Time frame: 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 aariation of blood lactate level.
Time frame: 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 6-Minute Walk Test (Adapted)
Time frame: 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
Change in Mini-Mental State Examination (MINI MENTAL).
Time frame: Baseline (before starting rehabilitation) and after 9 weeks.
To evaluate the cognitive functions, the MINI MENTAL test will be applied.
Change in Short Form 36 questionnaire (SF-36)
Time frame: 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
18 secondary outcomes
Follow-up: Evaluation Muscular electrical activity (Surface electromyograph)
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
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.
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.
Follow-up: Pulmonary function analysis (spirometry): forced vital capacity
Time frame: 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
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Pulmonary function analysis (spirometry):Tiffeneau Index
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Pulmonary function analysis (spirometry): maximum voluntary ventilation
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of inspiratory muscle strength
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of expiratory muscle strength
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of Peak expiratory flow.
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of the thoracic expandability (axillary level).
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of the thoracic expandability (xiphoid level).
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of abdominal level expandability.
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis of change in Infrared Thermography.
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Variation of blood lactate level.
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Analysis 6-Minute Walk Test (Adapted)
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Evaluation Mini-Mental State Examination (MINI MENTAL).
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Follow-up: Evaluation Short Form 36 questionnaire (SF-36)
Time frame: The follow-up revaluation will be 2 months after the end of rehabilitation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Derived from this study: PubMed 31232920Pinto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mário Oliveira Lima, Doctor principal investigator
Universidade do Vale do Paraíba - Univap
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Photobiomodulation and Cardiorespiratory Rehabilitation in people with Post Stroke and Post-Traumatic Headache, run by Universidade do Vale do Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Paula Pinto (55 12 981585974, apaula@outlook.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscular electrical activity (Surface electromyograph). (time frame: Baseline (before starting rehabilitation) and after 9 weeks.). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.