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NCT02504866 · ClinicalTrials.gov registry record · NA
Effect of Exercise Training on Physical, Cognitive, and Behavioral Function in People With TBI
A NA study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT02504866: Clinical Trial NA study, sponsored by National Institutes of Health Clinical Center (CC).
NCT02504866 is a NA study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02504866, a NA study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
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
Primary Outcome
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
Interventions
- OTHER Vigorous exercise
- OTHER Light to moderate exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-12-15 |
| Est. Completion | 2020-02-06 |
| Phase | NA |
Why NCT02504866 stopped before completion
NCT02504866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Vigorous exercise is the first listed.
NCT02504866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02504866 about?
NCT02504866 is a clinical study titled "Effect of Exercise Training on Physical, Cognitive, and Behavioral Function in People With TBI". 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...
What is the current status of trial NCT02504866?
This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2016-12-15. Estimated completion is 2020-02-06.
What interventions are being tested in trial NCT02504866?
The interventions under investigation include: Vigorous exercise (OTHER), Light to moderate exercise (OTHER).
Who is sponsoring clinical trial NCT02504866?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02504866's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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