Traumatic Brain InjuryNCT00619463
Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI
A study testing Exercise in people with Traumatic Brain Injury, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of the study is to determine the efficacy of aerobic exercise for improving cognition, mood, and fatigue after Traumatic Brain Injury (TBI) as well as examine the role of Brain Derived Neurotropic Factor (BDNF) and peripheral Vascular Endothelial Growth Factor (VEGF) as mediators of response to exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Oct 2012
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 to 99
- Have experienced a TBI as a result of a blow to the head with a loss of consciousness or a period of being dazed and confused. This must be medically documented (e.g. EMS report, hospital record, physician record).
- Be at least six-months post-injury
- Be English-speaking since assessments and treatment sessions will be conducted by English-speaking therapists
- Have residential telephone service since follow up assessments may be completed via phone
- Live within 1.5 hours of NYC to be able to participate in baseline assessment and attend treatment sessions
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- Provide written informed consent for participation
- Be willing to complete questionnaires and interviews about mood, thinking skills, fatigue, and life satisfaction
- Being willing to comply with protocol requirements and a schedule of exercise and assessments visits
- Being able to take part in a treadmill-based exercise program
Who cannot join
- Any medical condition in which exercising may be harmful, e.g., evidence of cardiovascular compromise including: history of acute myocardial infarction, history of coronary artery disease, unstable angina, uncontrolled hypertension, orthostatic hypotension, significant aortic valve disease, uncontrolled arrhythmia, uncompensated congestive heart failure, 3rd degree AV block without a pacemaker, active pericarditis, active myocarditis, or any evidence of pulmonary, endocrine or neurologic compromise; impaired left ventricular dysfunction; or syncopal episode within the past year
- Any medical condition requiring treatment with beta blockers or calcium channel blockers
- Under the age of 18 years of age
- Any clinically significant evidence of pulmonary, endocrine or neurologic (ataxia, gait disturbance, vertigo) compromise
- Resting pulse oxymetry of less than 95% oxygen (O2) saturation, in normal air
- Recent diagnosis of deep vein thrombosis or pulmonary embolism
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- Active systemic illness or chronic infection that is not stable
- Active inflammatory process that is not stable
- Clinically significant anemia
- Clinically significant abnormal thyroid function tests
- Pregnant females
- Any reason that, in the investigator's opinion, makes the person unsuitable to participate
- Unable to physically participate in an exercise program
- Active participation in regular aerobic exercise in the six months prior to potential enrollment.
- Active substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The purpose of the study is to determine the efficacy of aerobic exercise for improving cognition, mood, and fatigue after Traumatic Brain Injury (TBI) as well as examine the role of Brain Derived Neurotropic Factor (BDNF) and peripheral Vascular Endothelial Growth Factor (VEGF) as mediators of response to exercise.
Read the detailed description
The cognitive, emotional and physical effects of TBI are well documented in the literature. Specifically, reduced cognitive functioning and depression, which are much more prevalent than in the general population, represent key challenges in the rehabilitation of persons recovering from TBI. Aerobic exercise has been shown to improve cognition and mood in the general population. Although the positive effects of exercise have been known for some time, only recently have some of the mechanisms underlying these effects been defined. One hypothesized mechanism was that exercise elevates the levels of BDNF and VEGF in the CNS. Although research examining the effects of aerobic exercise in individuals with TBI is limited, exercise has been effective in improving cognition and depression in individuals with other medical conditions, such as cancer, multiple sclerosis, fibromyalgia, dementia, chronic fatigue syndrome, chronic obstructive pulmonary disease and the elderly.
The effects of aerobic exercise on patients with TBI will be examined in this clinical trial, using a crossover design with a wait-list control. The classic crossover design has been modified to examine the effects of an additional 8 weeks of exercise, for a total 16-week intervention, in one group. Participants will be randomized into one of two conditions: Group A - immediate eight weeks of intervention followed by monitoring or Group B - monitoring followed by 8 weeks of intervention. In addition, the participants in Group B will serve as their own controls to determine if another 8 weeks of exercise, for a total of 16 weeks, is necessary for cognitive improvement.
Each person will undergo individual interviews and testing/ questionnaires aimed at measuring cognition, mood, fatigue, and life satisfaction. Blood will be drawn 2 or 3 times to monitor BDNF and VEGF levels. Assessment of cognition, mood, fatigue and life satisfaction will occur at four time points for both groups.
It is hypothesized that aerobic exercise will result in improved cognition and mood from both subjective and objective perspectives. In addition, we will explore the effect of post-TBI exercise on community participation and life satisfaction and explore personal and injury characteristics that mediate effectiveness of aerobic exercise in individuals with TBI.
- Conditions
- Traumatic Brain Injury
- Being tested
- Exercise
- Keywords
- Traumatic Brain Injury, Exercise, Cognition, Brain Derived Neurotrophic Factor (BDNF), peripheral vascular endothelial growth factor (VEGF)
- Medical subject headings
- Brain Injuries, Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Eight weeks in an aerobic exercise program- 50 minutes of aerobic exercise on a treadmill - 3 days a week for 8 -16 weeks.
ExerciseBehavioural
Aerobic exercise program - 55 min aerobic exercise on the treadmill 3 days a week for either 8 or 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| exercise then monitor | Experimental | 8 weeks of aerobic exercise followed by 16 weeks of monitoring Receives: Behavioral: Exercise |
| monitor than exercise | Experimental | 8 weeks of monitoring followed by 16 weeks of aerobic exercise Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopkins Verbal Learning Test-Revised (HVLT-R)
Measured: Every 8 weeks for 24 weeks
Trail Making Tests A and B (TMT)
Measured: Every 8 weeks for 24 weeks
Digit span subtests of the WAIS-III
Measured: Every 8 weeks for 24 weeks
Wisconsin card sort test (WCST)
Measured: Every 8 weeks for 24 weeks
Controlled Oral Word Association Test (COWAT)
Measured: Every 8 weeks for 24 weeks
Stroop Word Color Test
Measured: Every 8 weeks for 24 weeks
Global Fatigue Index (GFI)
Measured: Every 8 weeks for 24 Weeks.
Beck Depression Inventory-II ( BDI-II)
Measured: Every 8 weeks for 24 Weeks.
Blood draws for assessment of BDNF and VEGF levels
Measured: Every 8 weeks for 24 weeks
Secondary outcomes (7)
Injury characteristics and demographic variables
Measured: At the beginning of the study. Week 1 of 24
BISQ - Brain Injury Screening Questionnaire
Measured: At the beginning of the study. Week 1 of 24
Life 3
Measured: Every 8 weeks for 24 Weeks
Transition Measures
Measured: Every 8 weeks for 24 Weeks
University of Rhode Island Change Assessment (URICA)
Measured: Every 8 weeks for 24 Weeks
Exercise Diaries
Measured: Once a day
International Physical Activity Questionnaire (IPAQ)
Measured: Once a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startAug 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- Wayne Gordon, Ph.D., Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619463
- Sponsor's protocol ID
- 1R49CE001171-01
- Status last verified
- Sep 2013
- First submitted
- 11 Feb 2008
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No