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

Not Applicable

• Conditions: Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System

• Registration Number: NCT01395472
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2011-04
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-15
• Last Update Submitted: 2011-07-27
• Last Update Posted: 2011-07-28
• Primary Completion: 2011-10
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 36

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neuropsychological evaluation	1 Day	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.

Secondary Outcome Measures

Name	Time	Method
Mood, fatigue and impulsivity questionnaires	1 day	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

Trial Locations

Locations (1)

Centro de Estudos em Psicobiologia e Exercício/AFIP; 🇧🇷 Sao Paulo, SP, Brazil