Brain Injuries Clinical Trial
Official title:
Influence of Physical Exercise on Cognitive Functioning of Traumatic Brain Injury Patients
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | February 2012 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
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: |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Centro de Estudos em Psicobiologia e Exercício/AFIP | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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