CClinicalTrials.gg
Status unknownNCT01395472Updated Jul 28, 2011

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

An interventional study of Acute Physical Exercise and Stretching protocol in Brain Injuries, Brain Diseases and Central Nervous System Diseases, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-28.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • TBI
  • Acute physical exercise
  • Cognitive functions
  • Mood
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 36 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Patients with TBI eligible for participation in this research study must meet the following inclusion criteria:

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

Exclusion Criteria:

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • 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

  • 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

  • Active comparator
    TBI Controls

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

    Behavioral: Stretching protocol

Interventions

  • BehavioralAcute 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.

  • BehavioralStretching protocol

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 Day

Secondary outcomes

  1. 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

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Centro de Estudos em Psicobiologia e Exercício/AFIP
    Sao Paulo, SP 04020-050, Brazil
    • Patricia Rzezak, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01395472
Lead sponsor
Federal University of São Paulo
First posted
Jul 15, 2011
Start date
Jan 2010
Primary completion
Oct 2011 (estimated)
Completion
Feb 2012 (estimated)
Last update
Jul 28, 2011

Study contacts

Patricia Rzezak, PhD
Contact
patriciarzezak@gmail.com
(5511)5572-0177
Marco T De Mello, PhD
study chair · Centro de Estudos em Psicobiologia e Exercício/AFIP
Patricia Rzezak, PhD
principal investigator · Centro de Estudos em Psicobiologia e Exercício/AFIP

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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