Aerobic Exercise and Transcranial Low Laser Therapy in Patients With C

Sensory-Motor and Cardiorespiratory Rehabilitation Associated With Transcranial Laser Therapy in Patients With Central Nervous System Injury

Status unknownNot a drug-phase studyMS (type not specified)NCT03751306

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Transcranial Photobiomodulation

Placebo

  • Transcranial Photobiomodulation (Placebo)

Given to everyone in the trial

  • Cardiorespiratory Rehabilitation

What it measured

Main measures

  • Change in Muscular electrical activity (Surface electromyograph).

    Baseline (before starting rehabilitation) and after 9 weeks.

  • Change in analysis of bipodal balance during the squat movement.

    Baseline (before starting rehabilitation) and after 9 weeks.

    Walking and mobility

  • Change in analysis of the heart rate variability to study the responses of the autonomic nervous system

    Baseline (First day of rehabilitation) and after 9 weeks (Last day of rehabilitation).

    Physical function

  • Change in Pulmonary function analysis (spirometry): forced vital capacity

    Baseline (before starting rehabilitation) and after 9 weeks.

  • Change in Pulmonary function analysis (spirometry): forced expiratory volume in the first second

    Baseline (before starting rehabilitation) and after 9 weeks.

  • Change in Pulmonary function analysis (spirometry): Tiffeneau Index

    Baseline (before starting rehabilitation) and after 9 weeks.

    Vision

  • Change in Pulmonary function analysis (spirometry): maximum voluntary ventilation

    Baseline (before starting rehabilitation) and after 9 weeks.

  • Change in analysis of inspiratory muscle strength

    Baseline (before starting rehabilitation) and after 9 weeks.

    Physical function

  • Analysis of expiratory muscle strength

    Baseline (before starting rehabilitation) and after 9 weeks.

    Physical function

  • Change in analysis of Peak expiratory flow.

    Baseline (before starting rehabilitation) and after 9 weeks.

  • Change in analysis of the thoracic expandability (axillary level).

    Baseline (before starting rehabilitation) and after 9 weeks.

    Walking and mobilityPhysical function

  • Change in analysis of the thoracic expandability (xiphoid level).

    Baseline (before starting rehabilitation) and after 9 weeks.

    Walking and mobilityPhysical function

  • Change in analysis of abdominal level expandability.

    Baseline (before starting rehabilitation) and after 9 weeks.

    Walking and mobilityPhysical function

  • Change in analysis of change in Infrared Thermography.

    Baseline (before starting rehabilitation) and after 9 weeks.

  • Change in aariation of blood lactate level.

    Baseline (before starting rehabilitation) and after 9 weeks.

    Physical function

  • Change in 6-Minute Walk Test (Adapted)

    Baseline (before starting rehabilitation) and after 9 weeks.

    Walking and mobilityPhysical function

  • Change in Mini-Mental State Examination (MINI MENTAL).

    Baseline (before starting rehabilitation) and after 9 weeks.

    Thinking and memory

  • Change in Short Form 36 questionnaire (SF-36)

    Baseline (before starting rehabilitation) and after 9 week.

    PainQuality of life (reported by participants)

Other measures (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.

    Walking and mobility

  • 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.

    Physical function

  • 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.

  • Follow-up: Pulmonary function analysis (spirometry):Tiffeneau Index

    The follow-up revaluation will be 2 months after the end of rehabilitation.

    Vision

  • Follow-up: Pulmonary function analysis (spirometry): maximum voluntary ventilation

    The follow-up revaluation will be 2 months after the end of rehabilitation.

  • Follow-up: Analysis of inspiratory muscle strength

    The follow-up revaluation will be 2 months after the end of rehabilitation.

    Physical function

  • Follow-up: Analysis of expiratory muscle strength

    The follow-up revaluation will be 2 months after the end of rehabilitation.

    Physical function

  • Follow-up: Analysis of Peak expiratory flow.

    The follow-up revaluation will be 2 months after the end of rehabilitation.

Who could take part

MS (type not specified) · 18 to 85

Show the full criteria

Inclusion criteria

* Persons with stroke, traumatic brain injury, spinal cord trauma, post-operative brain tumor, chronic non-progressive encephalopathy and multiple sclerosis; * Chronic neurological diseases, from 6 months of injury; * Caucasian individuals; * Age between 18 and 85 years; * Both sexes; * Individuals with the cognitive preserved; * Persons who are able to wander on the treadmill voluntarily or through assistance from the Rehabilitation and Physical Activity Station BrainMov®; * Persons who make continuous and regular use of medications prescribed by the physician for the control and / or treatment of chronic diseases; * People with the release of the cardiologist for rehabilitation.

Exclusion criteria

* People who do not meet the inclusion criteria; * Active smokers; * Carriers of chronic respiratory diseases, such as COPD, asthma and bronchiectasis; * Patients with decompensated heart disease; * Obesity grade II - body mass index greater than 34.99 kg / m2; * Patients with spinal cord injury above T6, who present autonomic dysreflexia; * Patients with ASA A or B spinal cord injury; * Patients with multiple sclerosis who are in an outbreak period; * Patients taking betablockers; * Hemorrhagic stroke.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jan 2019

    2. Main results due

      Jul 2019

    3. Finished

      Mar 2020

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