Influence of Physical Exercise on Cognitive Functioning of Traumatic Brain Injury Patients

Study Overview
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Brief Summary
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The aim of this study is to determine the effects of an acute session of physical exercise on cognitive functioning and humor of traumatic brain injury patients and to investigate whether different cognitive responses can be achieved with different intensities of exercise (moderate and vigorous). The investigators hypothesize that while moderate intensity physical exercise may be beneficial to cognitive functioning, vigorous intensity may be detrimental to TBI patients, as physical fatigue may impair alertness and other higher cognitive functions.

Detailed Description
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It is well known the benefits of physical exercise to cognitive functioning, which have been demonstrated in animal studies and in those with healthy humans or with individuals with some type of pathology. Nevertheless, there are few studies investigating the effects of acute physical exercise on cognitive functions of people with traumatic brain injury, even though they frequently have impairments in several cognitive domains due to their brain damage. The effect of two intensities of physical exercise (moderate and exhaustive) in attention, processing speed, memory, executive control and decision making will be investigated in patients with TBI. For that matter, their performance will be compared to non-brain injured subjects submitted to the same protocol and to TBI patients submitted to a stretching session. Each subject will be submitted to a neuropsychological evaluation before and after the physical exercise in order to determine if there is an improvement in cognitive performance post-exercise.

Official Title
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Influence of Physical Exercise on Cognitive Functioning of Traumatic Brain Injury Patients

Conditions
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Brain Injuries, Brain Diseases, Central Nervous System Diseases, Craniocerebral Trauma, Trauma, Nervous System

Intervention / Treatment
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* Behavioral: Acute Physical Exercise
* Behavioral: Stretching protocol


Participation Criteria
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Eligibility Criteria
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Patients with TBI eligible for participation in this research study must meet the following inclusion criteria: Inclusion Criteria: diagnose of moderate to severe TBI be at least six-months post-injury have a neurologist that allowed to enroll into the study be able to take part in a cycloergometer-protocol, attested by the laboratory (CEPE) physician brain injury must have occurred in adult life provided written informed consent for participation Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TBI - Experimental Sample<br>TBI patients will be submitted to two acute physical exercise protocols in a cycloergometer with one weak of interval (until voluntary exhaustion and 30 minutes in ventilatory threshold I) | Behavioral: Acute Physical Exercise<br>* Patients and healthy volunteers will be submitted to a protocol of progressive maximal exercise until voluntary exhaustion and one weak later to 30 minutes of physical exercise in ventilatory threshold I, both in the same cycloergometer.<br>|
| Active Comparator: Healthy Controls<br>healthy volunteers will be submitted to two acute physical exercise protocols in a cycloergometer with one weak of interval (until voluntary exhaustion and 30 minutes in ventilatory threshold I) | Behavioral: Acute Physical Exercise<br>* Patients and healthy volunteers will be submitted to a protocol of progressive maximal exercise until voluntary exhaustion and one weak later to 30 minutes of physical exercise in ventilatory threshold I, both in the same cycloergometer.<br>|
| Active Comparator: TBI Controls<br>Patients will be submitted to a protocol of stretching for 30 minutes | Behavioral: Stretching protocol<br>* TBI patients will be submitted to 30 minutes of stretching exercises composed of 15 exercises that prioritize back, legs and hip.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological evaluation | Neuropsychological evaluation will be held immediately before the execution of physical exercise (maximal, 30 minutes in ventilatory threshold I or stretching exercise) and immediately after the conclusion of exercise. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood, fatigue and impulsivity questionnaires | Mood, fatigue and impulsivity questionnaires will be held immediately before the execution of physical exercise (maximal, 30 minutes in ventilatory threshold I or stretching exercise) and immediately after the conclusion of exercise | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, Acute physical exercise, Cognitive functions, Mood