Brain InjuriesNCT01395472
Influence of Physical Exercise on Cognitive Functioning of Traumatic Brain Injury Patients
A study testing Acute Physical Exercise and Stretching protocol in people with Brain Injuries and Brain Diseases, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Brain Diseases, Central Nervous System Diseases
- What is being tested?
- Acute Physical Exercise and Stretching protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Centro de Estudos em Psicobiologia e Exercício/AFIP
São Paulo, São Paulo, 04020-050
Patricia Rzezak, PhD
About this study
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.
- Conditions
- Brain Injuries, Brain Diseases, Central Nervous System Diseases, Craniocerebral Trauma, Trauma, Nervous System
- Being tested
- Acute Physical Exercise, Stretching protocol
- Keywords
- TBI, Acute physical exercise, Cognitive functions, Mood
- Medical subject headings
- Brain Injuries, Brain Diseases, Central Nervous System Diseases, Craniocerebral Trauma, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Physical ExerciseBehavioural
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.
Stretching protocolBehavioural
TBI patients will be submitted to 30 minutes of stretching exercises composed of 15 exercises that prioritize back, legs and hip.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Behavioral: Acute Physical Exercise |
| TBI Controls | Active comparator | Patients will be submitted to a protocol of stretching for 30 minutes Receives: Behavioral: Stretching protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionOct 2011 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Marco T De Mello, PhD, Study chair, Centro de Estudos em Psicobiologia e Exercício/AFIPPatricia Rzezak, PhD, Principal investigator, Centro de Estudos em Psicobiologia e Exercício/AFIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395472
- Sponsor's protocol ID
- TBI-1858/09
- Status last verified
- Apr 2011
- First submitted
- 13 Jul 2011
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physical Exercise on Cognitive Functioning of Traumatic Brain Injury Patients
- ClinicalTrials.gov ID
- NCT01395472
- Acronym / sponsor ID
- TBI-1858/09
- Conditions
- Brain Injuries, Brain Diseases, Central Nervous System Diseases, Craniocerebral Trauma, Trauma, Nervous System
- Keywords
- TBI, Acute physical exercise, Cognitive functions, Mood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TBI - Experimental Sample | Experimental | Behavioral: Acute Physical ExerciseTBI 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) |
| Healthy Controls | Active comparator | Behavioral: Acute Physical Exercisehealthy 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) |
| TBI Controls | Active comparator | Behavioral: Stretching protocolPatients will be submitted to a protocol of stretching for 30 minutes |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Physical ExercisePatients 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. | Behavioural | Healthy Controls, TBI - Experimental Sample |
| Stretching protocolTBI patients will be submitted to 30 minutes of stretching exercises composed of 15 exercises that prioritize back, legs and hip. | Behavioural | TBI Controls |
Primary outcome
Neuropsychological evaluation
Time frame: 1 Day
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 secondary outcome
Mood, fatigue and impulsivity questionnaires
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Physical Exercise and Stretching protocol in people with Brain Injuries and Brain Diseases, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Rzezak, PhD ((5511)5572-0177, patriciarzezak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological evaluation (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.