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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Federal University of São Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395472
First Posted: July 15, 2011
Last Update Posted: July 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
July 13, 2011
July 15, 2011
July 28, 2011
January 2010
October 2011   (Final data collection date for primary outcome measure)
Neuropsychological evaluation [ Time Frame: 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.
Neuropsychological evaluation [ Time Frame: one day (immediately before physical exercise and immediately after the conclusion of the exercise) ]
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
Complete list of historical versions of study NCT01395472 on ClinicalTrials.gov Archive Site
Mood, fatigue and impulsivity questionnaires [ Time Frame: 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
Mood, fatigue and impulsivity questionnaires [ Time Frame: one day (immediately before physical exercise and immediately after the conclusion of the exercise) ]
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
Not Provided
Not Provided
 
Influence of Physical Exercise on Cognitive Functioning of Traumatic Brain Injury Patients
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Brain Injuries
  • Brain Diseases
  • Central Nervous System Diseases
  • Craniocerebral Trauma
  • Trauma, Nervous System
  • Behavioral: Acute Physical Exercise
    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.
  • Behavioral: Stretching protocol
    TBI patients will be submitted to 30 minutes of stretching exercises composed of 15 exercises that prioritize back, legs and hip.
  • Experimental: TBI - Experimental Sample
    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)
    Intervention: Behavioral: Acute Physical Exercise
  • Active Comparator: Healthy Controls
    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)
    Intervention: Behavioral: Acute Physical Exercise
  • Active Comparator: TBI Controls
    Patients will be submitted to a protocol of stretching for 30 minutes
    Intervention: Behavioral: Stretching protocol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
36
February 2012
October 2011   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01395472
TBI-1858/09
No
Not Provided
Not Provided
Patricia Rzezak PhD, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Study Chair: Marco T De Mello, PhD Centro de Estudos em Psicobiologia e Exercício/AFIP
Principal Investigator: Patricia Rzezak, PhD Centro de Estudos em Psicobiologia e Exercício/AFIP
Federal University of São Paulo
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP