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

Primary Purpose

Brain Injuries, Brain Diseases, Central Nervous System Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acute Physical Exercise
Stretching protocol
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring TBI, Acute physical exercise, Cognitive functions, Mood

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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:

Sites / Locations

  • Centro de Estudos em Psicobiologia e Exercício/AFIPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

TBI - Experimental Sample

Healthy Controls

TBI Controls

Arm Description

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)

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)

Patients will be submitted to a protocol of stretching for 30 minutes

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 13, 2011
Last Updated
July 27, 2011
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01395472
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
February 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Brain Diseases, Central Nervous System Diseases, Craniocerebral Trauma, Trauma, Nervous System
Keywords
TBI, Acute physical exercise, Cognitive functions, Mood

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TBI - Experimental Sample
Arm Type
Experimental
Arm Description
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)
Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
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)
Arm Title
TBI Controls
Arm Type
Active Comparator
Arm Description
Patients will be submitted to a protocol of stretching for 30 minutes
Intervention Type
Behavioral
Intervention Name(s)
Acute Physical Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stretching protocol
Intervention Description
TBI patients will be submitted to 30 minutes of stretching exercises composed of 15 exercises that prioritize back, legs and hip.
Primary Outcome Measure Information:
Title
Neuropsychological evaluation
Description
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.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Mood, fatigue and impulsivity questionnaires
Description
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
Time Frame
1 day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Rzezak, PhD
Phone
(5511)5572-0177
Email
patriciarzezak@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco T De Mello, PhD
Organizational Affiliation
Centro de Estudos em Psicobiologia e Exercício/AFIP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patricia Rzezak, PhD
Organizational Affiliation
Centro de Estudos em Psicobiologia e Exercício/AFIP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Estudos em Psicobiologia e Exercício/AFIP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04020-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Rzezak, PhD

12. IPD Sharing Statement

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

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