Ignite Creation Date:
2024-05-05 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00619463
Status:
COMPLETED
Last Update Posted:
2013-09-24
First Post:
2008-02-11
Brief Title:
Effects of Aerobic Exercise on Cognition Mood and Fatigue Following TBI
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Effects of Aerobic Exercise on Cognition Mood and Fatigue Following TBI
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None