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

Mount Sinai Health System

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Behavioral: Exercise

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00619463

1R49CE001171-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

154 patients

Sex

All

Ages

18+ years old

Volunteers

No 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