Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI
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|ClinicalTrials.gov Identifier: NCT00619463|
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : September 24, 2013
|Condition or disease||Intervention/treatment|
|Traumatic Brain Injury||Behavioral: Exercise|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI|
|Study Start Date :||August 2007|
|Primary Completion Date :||October 2012|
|Study Completion Date :||October 2012|
Experimental: exercise then monitor
8 weeks of aerobic exercise followed by 16 weeks of monitoring
Eight weeks in an aerobic exercise program- 50 minutes of aerobic exercise on a treadmill - 3 days a week for 8 -16 weeks.
Experimental: monitor than exercise
8 weeks of monitoring followed by 16 weeks of aerobic exercise
Aerobic exercise program - 55 min aerobic exercise on the treadmill 3 days a week for either 8 or 16 weeks
- Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Every 8 weeks for 24 weeks ]
- Trail Making Tests A and B (TMT) [ Time Frame: Every 8 weeks for 24 weeks ]
- Digit span subtests of the WAIS-III [ Time Frame: Every 8 weeks for 24 weeks ]
- Wisconsin card sort test (WCST) [ Time Frame: Every 8 weeks for 24 weeks ]
- Controlled Oral Word Association Test (COWAT) [ Time Frame: Every 8 weeks for 24 weeks ]
- Stroop Word Color Test [ Time Frame: Every 8 weeks for 24 weeks ]
- Global Fatigue Index (GFI) [ Time Frame: Every 8 weeks for 24 Weeks. ]
- Beck Depression Inventory-II ( BDI-II) [ Time Frame: Every 8 weeks for 24 Weeks. ]
- Blood draws for assessment of BDNF and VEGF levels [ Time Frame: Every 8 weeks for 24 weeks ]
- Injury characteristics and demographic variables [ Time Frame: At the beginning of the study. Week 1 of 24 ]
- BISQ - Brain Injury Screening Questionnaire [ Time Frame: At the beginning of the study. Week 1 of 24 ]
- Life 3 [ Time Frame: Every 8 weeks for 24 Weeks ]
- Transition Measures [ Time Frame: Every 8 weeks for 24 Weeks ]
- University of Rhode Island Change Assessment (URICA) [ Time Frame: Every 8 weeks for 24 Weeks ]
- Exercise Diaries [ Time Frame: Once a day ]
- International Physical Activity Questionnaire (IPAQ) [ Time Frame: Once a week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619463
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Study Director:||Wayne Gordon, Ph.D.||Icahn School of Medicine at Mount Sinai|