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

NCT ID: NCT01395472

Last Updated: 2011-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-02-29

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Acute Physical Exercise

Intervention Type: BEHAVIORAL

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.

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)

Group Type: ACTIVE_COMPARATOR

Acute Physical Exercise

Intervention Type: BEHAVIORAL

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.

TBI Controls

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

Group Type: ACTIVE_COMPARATOR

Stretching protocol

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Stretching protocol

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Federal University of São Paulo

Principal Investigators

Marco T De Mello, PhD

Role: STUDY_CHAIR

Centro de Estudos em Psicobiologia e Exercício/AFIP

Patricia Rzezak, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro de Estudos em Psicobiologia e Exercício/AFIP

Locations

Centro de Estudos em Psicobiologia e Exercício/AFIP

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Patricia Rzezak, PhD

Role: CONTACT

patriciarzezak@gmail.com

(5511)5572-0177

Other Identifiers

TBI-1858/09

Identifier Type: -

Identifier Source: org_study_id