National Institutes of Health Clinical Center (CC)
Who can join
Adults 18 to 79, any sex, with Traumatic Brain Injury (TBI). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Cognitive Function as Measured by Trail Making Test Part B (TMT-B)Primary· Before (pre) and after (post) 12 weeks intervention
Trail Making Test (TMT) is a neuropsychological assessment of visual conceptual and visual motor tracking (involves motor speed and attention functions). Trail Making Test Part B (TMT-B) is associated with executive functioning and involves drawing a line connecting alternating numbers and letters in sequence (i.e., 1-A-2-B and so on). The time to complete the test is recorded. The time taken to complete the test was converted into standardized T-scores, representing a mean of 50 and a standard deviation of 10. Higher T-scores mean less cognitive deficits. The change in cognitive function was
Group
Value
95% CI
Aerobic Exercise Intervention (AET)
4.5
± 3.7
Rapid-Resistive Exercise Intervention (RET)
-6.33
± 29.02
Waitlist Control (CON)
-6.75
± 17.17
Adverse events — posted to ClinicalTrials.gov
Time frame: 9 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT03138187 — Physical Exercise and Energy Balance
· NA
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC)
Last refreshed: 18 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02504866.