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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01395472
• Other study ID #: TBI-1858/09
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2011
• Last updated: July 27, 2011
• Start date: January 2010
• Est. completion date: February 2012

Study information

• Verified date: April 2011
• Source: Federal University of São Paulo
• Contact: Patricia Rzezak, PhD
• Phone: (5511)5572-0177
• Email: patriciarzezak[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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:

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Central Nervous System Diseases
• Craniocerebral Trauma
• Nervous System Diseases
• Trauma, Nervous System

Intervention

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.
• Stretching protocol
TBI patients will be submitted to 30 minutes of stretching exercises composed of 15 exercises that prioritize back, legs and hip.

Locations

Country	Name	City	State
Brazil	Centro de Estudos em Psicobiologia e Exercício/AFIP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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