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

Protocol Details

Effect of Aerobic Exercise Training on Cardiorespiratory Fitness in Patients with Traumatic Brain Injury

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




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


Population Exclusion(s)

Non-English Speaking


Aerobic Exercise Training;
Cardiorespiratory Fitness

Recruitment Keyword(s)



Physical Fitness;
Traumatic Brain Injury

Investigational Drug(s)


Investigational Device(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.


- To examine the effect of an aerobic treadmill walking exercise program on physical fitness, fatigue, and mood in people with TBI.


- 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.


- 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.

--Back to Top--



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


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)

--Back to Top--


Not Provided

--Back to Top--


Principal Investigator

Referral Contact

For more information:

Leighton Chan, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CRC BG RM 1-1469
(301) 496-4733

Leighton Chan, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CRC BG RM 1-1469
(301) 496-4733

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: TTY Users Dial 7-1-1

Clinical Trials Number:


--Back to Top--