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.

Study Overview

• Status: Unknown
• Conditions: Brain Diseases; Central Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System
• Intervention / Treatment: Behavioral: Acute Physical Exercise; Behavioral: Stretching protocol

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04020-050
      • Recruiting
      • Centro de Estudos em Psicobiologia e Exercício/AFIP
      • Principal Investigator: Patricia Rzezak, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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.
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)	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.
Active Comparator: TBI Controls; Patients will be submitted to a protocol of stretching for 30 minutes	Behavioral: Stretching protocol; TBI patients will be submitted to 30 minutes of stretching exercises composed of 15 exercises that prioritize back, legs and hip.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): February 1, 2012

Study Registration Dates

• First Submitted: July 13, 2011
• First Submitted That Met QC Criteria: July 14, 2011
• First Posted (Estimate): July 15, 2011

Study Record Updates

• Last Update Posted (Estimate): July 28, 2011
• Last Update Submitted That Met QC Criteria: July 27, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: TBI; Mood; Cognitive functions; Acute physical exercise
• Additional Relevant MeSH Terms: Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Nervous System Diseases; Brain Diseases; Craniocerebral Trauma; Trauma, Nervous System; Central Nervous System Diseases
• Other Study ID Numbers: TBI-1858/09