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

Federal University of São Paulo

Status: Unknown

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

Treatments: Behavioral: Stretching protocol; Behavioral: Acute Physical Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01395472

TBI-1858/09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

TBI - Experimental Sample

Experimental group

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)

Treatment:

Behavioral: Acute Physical Exercise

Healthy Controls

Active Comparator group

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)

Treatment:

Behavioral: Acute Physical Exercise

TBI Controls

Active Comparator group

Description:

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

Treatment:

Behavioral: Stretching protocol