This study is NOT currently recruiting participants.
Number
15-CC-0164
Sponsoring Institute
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: 79 Years
Referral Letter Required
No
Population Exclusion(s)
Non-English Speaking;Children
Keywords
Aerobic Exercise Training; Balance; TBI; Rapid-Resistive Exercise
Recruitment Keyword(s)
None
Condition(s)
Traumatic Brain Injury (Tbi)
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Other: Vigorous exercise Other: Light to moderate exercise
Supporting Site
NIH Clinical Center
- Traumatic brain injury (TBI) often causes problems with moving and balance, and thinking and emotions. Exercise can improve these things in people with other brain damage. Researchers want to look at the effect of exercise on these things in people with TBI.
Objectives:
- To study how head injuries affect the brain. To study if exercise can help some symptoms in people with TBI. These include problems thinking, balancing, and moving, and depression or anxiety.
Eligibility:
- People age between 18 and 79
- Had a non-penetrating TBI at least 12 months ago
- Are physically inactive, but can stand and walk without help
Design:
- Participants will be screened with medical history, physical exam, and blood and urine tests. They may have a balance test.
- Participants will be assigned to a high-intensity or a lower-intensity exercise program.
- The study is 6 months long. There will be 3 months with exercise on an elliptical machine and 3 months without exercise.
- Participants will exercise for 30 minutes on an elliptical machine, 3 days per week for 3 months.
- Participants will also have 3 outpatient testing visits lasting approximately 8 hours, once every 3 months. This visit will include:
- Blood tests
- Tests for memory, attention, and thinking
- Tests of walking and balance
- Questionnaires
- An MRI: they will lie in a machine that takes pictures of their brain, while breathing regular air and air with more carbon dioxide
- Test of physical fitness
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INCLUSION CRITERIA: Inclusion criteria for those with TBI: 1. Ages 18 to 79 inclusive 2. Diagnosis of non-penetrating TBI 3. Injury occurred at least 12 months prior to enrollment 4. Physically inactive as identified by a physician 5. Able to stand and walk independently and safely without any assistance 6. Able to follow the study protocol 7. Fluent in English and able to provide informed consent Inclusion criteria for healthy volunteers: 1. Ages 18 to 79 inclusive 2. Physically inactive as identified by a physician 3. Fluent in English EXCLUSION CRITERIA: Exclusion criteria for those with TBI: 1. History of exercise intolerance 2. History of heart disease 3. History of pulmonary disease, other than controlled, non-exercise-induced asthma 4. History of uncontrolled diabetes 5. Uncontrolled hypertension, defined as a resting blood pressure > 140/90 mmHg 6. On medications that would influence aerobic capacity or treadmill performance such as beta blockers or antiretroviral therapy 7. Active substance abuse including ETOH 8. Presence of an injury to any extremity, or other medical condition that would affect motor function or the ability to perform the assessment or the exercise program, specifically balance problems due to vestibulopathy 9. Unable to refrain from smoking at least 4 hours prior to exercise testing sessions 10. Medical or psychological instability such that the subject could not reasonably be expected to fulfill the study requirements 11. Pregnancy 12. BMI >40 kg/M(2) due to the limits of the treadmill, elliptical machine and MRI scanner 13. Planning to make a change in medication or therapy during the enrollment period with the goal of improving mood, cognitive function or motor function 14. Have any of the following contraindications to having an MRI scan: a. A ventriculo-peritoneal shunt b. Have claustrophobia and not comfortable in small enclosed spaces c. Have metal that would make an MRI scan unsafe such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion devise, cochlear or ear implant, transdermal medication patch (nitroglycerine), any metallic implants or objects, body piercing that cannot be removed, bone or joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal embedded (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near your eyes). d. Excessive startle reaction to or fear of loud noises Exclusion criteria for healthy volunteers: 1. History or presence of cardiopulmonary or respiratory disease 2. History or presence of other disease of the neurologic, metabolic, or renal systems 3. Active substance abuse including ETOH 4. Pregnancy 5. BMI >40 kg/m2 6. Medical or psychological instability such that the subject could not reasonably be expected to fulfill the study requirements 7. Have any contraindications to having an MRI scan
Inclusion criteria for those with TBI:
1. Ages 18 to 79 inclusive
2. Diagnosis of non-penetrating TBI
3. Injury occurred at least 12 months prior to enrollment
4. Physically inactive as identified by a physician
5. Able to stand and walk independently and safely without any assistance
6. Able to follow the study protocol
7. Fluent in English and able to provide informed consent
Inclusion criteria for healthy volunteers:
2. Physically inactive as identified by a physician
3. Fluent in English
EXCLUSION CRITERIA:
Exclusion criteria for those with TBI:
1. History of exercise intolerance
2. History of heart disease
3. History of pulmonary disease, other than controlled, non-exercise-induced asthma
4. History of uncontrolled diabetes
5. Uncontrolled hypertension, defined as a resting blood pressure > 140/90 mmHg
6. On medications that would influence aerobic capacity or treadmill performance such as beta blockers or antiretroviral therapy
7. Active substance abuse including ETOH
8. Presence of an injury to any extremity, or other medical condition that would affect motor function or the ability to perform the assessment or the exercise program, specifically balance problems due to vestibulopathy
9. Unable to refrain from smoking at least 4 hours prior to exercise testing sessions
10. Medical or psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
11. Pregnancy
12. BMI >40 kg/M(2) due to the limits of the treadmill, elliptical machine and MRI scanner
13. Planning to make a change in medication or therapy during the enrollment period with the goal of improving mood, cognitive function or motor function
14. Have any of the following contraindications to having an MRI scan:
a. A ventriculo-peritoneal shunt
b. Have claustrophobia and not comfortable in small enclosed spaces
c. Have metal that would make an MRI scan unsafe such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion devise, cochlear or ear implant, transdermal medication patch (nitroglycerine), any metallic implants or objects, body piercing that cannot be removed, bone or joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal embedded (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near your eyes).
d. Excessive startle reaction to or fear of loud noises
Exclusion criteria for healthy volunteers:
1. History or presence of cardiopulmonary or respiratory disease
2. History or presence of other disease of the neurologic, metabolic, or renal systems
3. Active substance abuse including ETOH
4. Pregnancy
5. BMI >40 kg/m2
6. Medical or psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
7. Have any contraindications to having an MRI scan
Principal Investigator
Referral Contact
For more information: