Walking it off: treadmill training may boost fitness and mood in brain injury survivors
NCT ID NCT01294332
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 5 times
Summary
This study looked at whether a 12-week treadmill exercise program can improve cardiorespiratory fitness, reduce fatigue, and boost mood in people with traumatic brain injury (TBI). Thirteen physically inactive adults with TBI walked on a treadmill three times a week for 30 minutes at a target heart rate. Researchers measured changes in peak oxygen consumption, fatigue, and mood before and after the program.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- supervised treadmill aerobic exercise
- What this could lead to
- If it works, this could show that structured exercise helps improve physical fitness and reduce fatigue and mood problems after traumatic brain injury.
- What could go wrong
- This is a very small early-phase study with only 13 participants, so results may not apply to everyone. It also requires participants to be able to walk on a treadmill safely, which limits who can take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
13 people
The number who actually took part.
- Started
-
May 2011
- Finished
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Feb 2014
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 45 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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