NCT01395472

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

July 28, 2011

Status Verified

April 1, 2011

Enrollment Period

1.7 years

First QC Date

July 13, 2011

Last Update Submit

July 27, 2011

Conditions

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous System

Keywords

TBIAcute physical exerciseCognitive functionsMood

Outcome Measures

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.

    1 Day

Secondary Outcomes (1)

  • Mood, fatigue and impulsivity questionnaires

    1 day

Study Arms (3)

TBI - Experimental Sample

EXPERIMENTAL

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

Healthy Controls

ACTIVE COMPARATOR

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

TBI Controls

ACTIVE COMPARATOR

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

Behavioral: Stretching protocol

Interventions

Acute Physical ExerciseBEHAVIORAL

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 ControlsTBI - Experimental Sample
Stretching protocolBEHAVIORAL

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

TBI Controls

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Estudos em Psicobiologia e Exercício/AFIP

São Paulo, São Paulo, 04020-050, Brazil

RECRUITING

MeSH Terms

Conditions

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous System

Condition Hierarchy (Ancestors)

Nervous System DiseasesWounds and Injuries

Study Officials

  • Marco T De Mello, PhD

    Centro de Estudos em Psicobiologia e Exercício/AFIP

    STUDY CHAIR

  • Patricia Rzezak, PhD

    Centro de Estudos em Psicobiologia e Exercício/AFIP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Rzezak, PhD

CONTACT

(5511)5572-0177patriciarzezak@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 15, 2011

Study Start

January 1, 2010

Primary Completion

October 1, 2011

Study Completion

February 1, 2012

Last Updated

July 28, 2011

Record last verified: 2011-04

Locations

BR(1)