Clinical trial NCT01395472: Influence of Physical Exercise on Cognitive Functioning of Traumatic Brain Injury Patients
Official title: Influence of Physical Exercise on Cognitive Functioning of Traumatic Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Keywords: TBI
Acute physical exercise
Cognitive functions
Mood
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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:

Primary outcomes:
measure: Neuropsychological evaluation
timeFrame: 1 Day
Secondary outcomes:
measure: Mood, fatigue and impulsivity questionnaires
timeFrame: 1 day
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Estudos em Psicobiologia e Exercício/AFIP
state: SP
Study officials:
affiliation: Centro de Estudos em Psicobiologia e Exercício/AFIP
name: Marco T De Mello, PhD
role: STUDY_CHAIR
affiliation: Centro de Estudos em Psicobiologia e Exercício/AFIP
name: Patricia Rzezak, PhD
role: PRINCIPAL_INVESTIGATOR
References: