NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Effect of Exercise Training on Physical, Cognitive and Behavioral Function in Patients with Traumatic Brain Injury

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-CC-0164

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 79

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking;
Children

Special Instructions

Currently Not Provided

Keywords

Aerobic Exercise Training;
Balance;
TBI

Recruitment Keyword(s)

None

Condition(s)

Traumatic Brain Injury

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Exercise

Supporting Site

NIH Clinical Center

Background:

- 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.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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


--Back to Top--

Citations:

Chin LM, Keyser RE, Dsurney J, Chan L. Improved cognitive performance following aerobic exercise training in people with traumatic brain injury. Arch Phys Med Rehabil. 2015 Apr;96(4):754-9. doi: 10.1016/j.apmr.2014.11.009. Epub 2014 Nov 26.

Chin LM, Chan L, Woolstenhulme JG, Christensen EJ, Shenouda CN, Keyser RE. Improved Cardiorespiratory Fitness With Aerobic Exercise Training in Individuals With Traumatic Brain Injury. J Head Trauma Rehabil. 2014 Jun 4. [Epub ahead of print]

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Diane L. Damiano, Ph.D.
National Institutes of Health Clinical Center (CC)



Lisa M. Chin, Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1-1469
10 Center Drive
Bethesda, Maryland 20892
(301) 443-9072
chinlm@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02504866

--Back to Top--