UnknownNot Applicable

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

Brazil90 participantsStarted 2019-01-14

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Muscular electrical activity (Surface electromyograph).

Timeframe: Baseline (before starting rehabilitation) and after 9 weeks.

Change in analysis of bipodal balance during the squat movement.

Timeframe: 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

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

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

Timeframe: Baseline (before starting rehabilitation) and after 9 weeks.

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

Timeframe: Baseline (before starting rehabilitation) and after 9 weeks.

Change in Pulmonary function analysis (spirometry): Tiffeneau Index

Timeframe: Baseline (before starting rehabilitation) and after 9 weeks.

Trial details

NCT IDNCT03751306

SponsorUniversidade do Vale do Paraíba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-31

Contact for this trial

Ana Paula Pinto

55 12 981585974 apaula@outlook.com.br

View on ClinicalTrials.gov More Post Stroke trials