This study is NOT currently recruiting participants.
Number
11-CC-0088
Sponsoring Institute
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 21 Max Age: 45
Referral Letter Required
No
Population Exclusion(s)
Children;Non-English Speaking
Keywords
Cognition; TBI; Mood; Aerobic Exercise Training; Cardiorespiratory Fitness
Recruitment Keyword(s)
None
Condition(s)
Exercise; Fatigue; Physical Fitness; Traumatic Brain Injury
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Other: Aerobic Exercise Training
Supporting Site
NIH Clinical CenterCenter for Neuroscience and Regenerative Medicine (CNRM)
- Many people who have traumatic brain injury (TBI) have low levels of physical fitness. Low physical fitness causes severe fatigue that reduces the ability to perform routine daily activities, and may also cause increased depression, anxiety, or sadness. Aerobic exercise, such as treadmill walking or running, improves physical fitness in most people and may also decrease fatigue and improve mood. However, more information is needed to determine if exercise improves these conditions in people who have TBI.
Objectives:
- To examine the effect of an aerobic treadmill walking exercise program on physical fitness, fatigue, and mood in people with TBI.
Eligibility:
- Individuals between 21 and 45 years of age who had a nonpenetrating traumatic brain injury at least 6 months before participating; able to understand oral and written English language, give informed consent and sign a consent form; are physically inactive (including activities related to both job and recreation); and are able to stand and walk on a treadmill safely without help.
Design:
- This study requires 4 testing visits and 36 exercise visits over 14 weeks.
- The first and third testing visits will last about 4 hours and the second and final testing visits will take about 2 hours.
- Testing visits will consist of a medical history and physical examination, completion of questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall quality of life), tests of thinking and a treadmill exercise test.
- Participants will have treadmill exercise training 3 days per week for 12 weeks. Each session includes a check-in, warm-up, treadmill walking at the training heart rate, and cool-down. Thirty-two of the sessions will last for about 1 hour, and four of the sessions will include questionnaires to fill out and will last about one-and-a-half hours.
- After completing the exercise training program, participants will have a final testing visit to complete the questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall quality of life), tests of thinking and a treadmill exercise test.
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INCLUSION CRITERIA: Subjects eligible for participation in this research study must meet the following inclusion criteria: 1. Diagnosis of non-penetrating mild, moderate, or severe TBI 2. Injury occurred at least 6 months prior to enrollment 3. Age 21-45 years 4. Physically inactive as identified by a physician. 5. Able to stand and walk on a treadmill independently and safely without assistance 6. Able to follow the study protocol 7. Fluent in English and able to provide informed consent 8. Willing and safely able to forego starting or changing an exercise program or treatments that would potentially alter cardiorespiratory capacity or ability to exercise and/or treatment for mood disorders EXCLUSION CRITERIA: Subjects are not eligible for participation in this research study if any of the following medical conditions that would impair aerobic capacity or the ability to engage in physical activity exist, including diseases of the cardiovascular (other than hypertension controlled by medication to below 140/90 mmHg), pulmonary, neurological, metabolic, or musculoskeletal systems such as: 1. Diagnosis or history of ischemic heart disease, including those with CABG and PTCA 2. Dilated or hypertrophic cardiomyopathy 3. Non-idiopathic cardiomyopathy 4. Uncontrolled hypertension, defined as a resting blood pressure above 140/90 mmHg 5. Diagnosis or history of right or left-sided heart failure or pulmonary hypertension 6. Diagnosis or history of restrictive or obstructive lung disease 7. Diagnosis or history of stroke 8. Type I or Type II Diabetes Mellitus 9. Diagnosis of chronic kidney disease, chronic liver disease, acute kidney injury or acute liver failure 10. Metastatic cancer active within the previous five years 11. Mitochondrial disease 12. On medications that would influence aerobic capacity, the ability to adapt to exercise training, or treadmill performance such as beta blockers or antiretroviral therapy 13. Active substance abuse including ETOH 14. Ongoing tobacco use (any use within the past six months) 15. Medical or Psychological instability such that the subject could not reasonably be expected to fulfill the study requirements 16. Pregnancy 17. BMI greater than 40 kg/m(2)
Subjects eligible for participation in this research study must meet the following inclusion criteria:
1. Diagnosis of non-penetrating mild, moderate, or severe TBI
2. Injury occurred at least 6 months prior to enrollment
3. Age 21-45 years
4. Physically inactive as identified by a physician.
5. Able to stand and walk on a treadmill independently and safely without assistance
6. Able to follow the study protocol
7. Fluent in English and able to provide informed consent
8. Willing and safely able to forego starting or changing an exercise program or treatments that would potentially alter cardiorespiratory capacity or ability to exercise and/or treatment for mood disorders
EXCLUSION CRITERIA:
Subjects are not eligible for participation in this research study if any of the following medical conditions that would impair aerobic capacity or the ability to engage in physical activity exist, including diseases of the cardiovascular (other than hypertension controlled by medication to below 140/90 mmHg), pulmonary, neurological, metabolic, or musculoskeletal systems such as:
1. Diagnosis or history of ischemic heart disease, including those with CABG and PTCA
2. Dilated or hypertrophic cardiomyopathy
3. Non-idiopathic cardiomyopathy
4. Uncontrolled hypertension, defined as a resting blood pressure above 140/90 mmHg
5. Diagnosis or history of right or left-sided heart failure or pulmonary hypertension
6. Diagnosis or history of restrictive or obstructive lung disease
7. Diagnosis or history of stroke
8. Type I or Type II Diabetes Mellitus
9. Diagnosis of chronic kidney disease, chronic liver disease, acute kidney injury or acute liver failure
10. Metastatic cancer active within the previous five years
11. Mitochondrial disease
12. On medications that would influence aerobic capacity, the ability to adapt to exercise training, or treadmill performance such as beta blockers or antiretroviral therapy
13. Active substance abuse including ETOH
14. Ongoing tobacco use (any use within the past six months)
15. Medical or Psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
16. Pregnancy
17. BMI greater than 40 kg/m(2)
Principal Investigator
Referral Contact
For more information: