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Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI

Primary Purpose

Traumatic Brain Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Exercise, Cognition, Brain Derived Neurotrophic Factor (BDNF), peripheral vascular endothelial growth factor (VEGF)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

exercise then monitor

monitor than exercise

Arm Description

8 weeks of aerobic exercise followed by 16 weeks of monitoring

8 weeks of monitoring followed by 16 weeks of aerobic exercise

Outcomes

Primary Outcome Measures

Hopkins Verbal Learning Test-Revised (HVLT-R)

Trail Making Tests A and B (TMT)

Digit span subtests of the WAIS-III

Wisconsin card sort test (WCST)

Controlled Oral Word Association Test (COWAT)

Stroop Word Color Test

Global Fatigue Index (GFI)

Beck Depression Inventory-II ( BDI-II)

Blood draws for assessment of BDNF and VEGF levels

Secondary Outcome Measures

Injury characteristics and demographic variables

BISQ - Brain Injury Screening Questionnaire

Life 3

Transition Measures

University of Rhode Island Change Assessment (URICA)

Exercise Diaries

International Physical Activity Questionnaire (IPAQ)

Full Information

NCT ID

NCT00619463

First Posted

February 11, 2008

Last Updated

September 23, 2013

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Centers for Disease Control and Prevention, U.S. Department of Education

1. Study Identification

Unique Protocol Identification Number

NCT00619463

Brief Title

Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI

Official Title

Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Centers for Disease Control and Prevention, U.S. Department of Education

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

Keywords

Traumatic Brain Injury, Exercise, Cognition, Brain Derived Neurotrophic Factor (BDNF), peripheral vascular endothelial growth factor (VEGF)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

exercise then monitor

Arm Type

Experimental

Arm Description

8 weeks of aerobic exercise followed by 16 weeks of monitoring

Arm Title

monitor than exercise

Arm Type

Experimental

Arm Description

8 weeks of monitoring followed by 16 weeks of aerobic exercise

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

Eight weeks in an aerobic exercise program- 50 minutes of aerobic exercise on a treadmill - 3 days a week for 8 -16 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

Aerobic exercise program - 55 min aerobic exercise on the treadmill 3 days a week for either 8 or 16 weeks

Primary Outcome Measure Information:

Title

Hopkins Verbal Learning Test-Revised (HVLT-R)

Time Frame

Every 8 weeks for 24 weeks

Title

Trail Making Tests A and B (TMT)

Time Frame

Every 8 weeks for 24 weeks

Title

Digit span subtests of the WAIS-III

Time Frame

Every 8 weeks for 24 weeks

Title

Wisconsin card sort test (WCST)

Time Frame

Every 8 weeks for 24 weeks

Title

Controlled Oral Word Association Test (COWAT)

Time Frame

Every 8 weeks for 24 weeks

Title

Stroop Word Color Test

Time Frame

Every 8 weeks for 24 weeks

Title

Global Fatigue Index (GFI)

Time Frame

Every 8 weeks for 24 Weeks.

Title

Beck Depression Inventory-II ( BDI-II)

Time Frame

Every 8 weeks for 24 Weeks.

Title

Blood draws for assessment of BDNF and VEGF levels

Time Frame

Every 8 weeks for 24 weeks

Secondary Outcome Measure Information:

Title

Injury characteristics and demographic variables

Time Frame

At the beginning of the study. Week 1 of 24

Title

BISQ - Brain Injury Screening Questionnaire

Time Frame

At the beginning of the study. Week 1 of 24

Title

Life 3

Time Frame

Every 8 weeks for 24 Weeks

Title

Transition Measures

Time Frame

Every 8 weeks for 24 Weeks

Title

University of Rhode Island Change Assessment (URICA)

Time Frame

Every 8 weeks for 24 Weeks

Title

Exercise Diaries

Time Frame

Once a day

Title

International Physical Activity Questionnaire (IPAQ)

Time Frame

Once a week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wayne Gordon, Ph.D.

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Study Director

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

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Effects of Aerobic Exercise on Cognition, Mood and Fatigue Following TBI

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