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NCT04199247 · ClinicalTrials.gov registry record · NA
Early Exercise to Improve Psychosocial Function After Pediatric Mild Traumatic Brain Injury
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT04199247: Completed NA study, sponsored by University of Colorado, Denver.
NCT04199247 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 16 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
NCT04199247, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
The investigators will test the central hypotheses according to the following Specific Aims: Aim 1. Determine if an individually prescribed exercise program initiated within the first week of mild traumatic brain injury can reduce the risk of developing persistent post-concussion symptoms relative to usual care. The investigators hypothesize that the exercise group will have a lower risk of developing persistent post-concussion symptoms than the usual care group. Aim 2. Examine the effect of a two-month exercise program on psycho-social, pain interference, and sleep outcomes following mild traumatic brain injury. The investigators hypothesize the exercise group will report lower anxiety, depression, and pain interference ratings, and higher peer relationship and sleep quality ratings two months of exercise following mild traumatic brain injury compared to usual care.
Primary Outcome
Overall symptom severity, rated as a sum score from 0-122. A higher score indicates more severe symptoms, while a 0 indicates that the patient is not experiencing symptoms.
Interventions
- BEHAVIORAL Sub symptom aerobic exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-02-20 |
| Est. Completion | 2021-11-08 |
| Phase | NA |
What the finished NCT04199247 record still lists
NCT04199247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 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 1 intervention - of which Sub symptom aerobic exercise is the first listed.
NCT04199247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04199247 about?
NCT04199247 is a clinical study titled "Early Exercise to Improve Psychosocial Function After Pediatric Mild Traumatic Brain Injury". The investigators will test the central hypotheses according to the following Specific Aims: Aim 1. Determine if an individually prescribed exercise program initiated within the first week of mild traumatic brain injury can reduce the risk of developing persistent post-concussion symptoms relative ...
What is the current status of trial NCT04199247?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2020-02-20. Estimated completion is 2021-11-08.
What interventions are being tested in trial NCT04199247?
The interventions under investigation include: Sub symptom aerobic exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT04199247?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04199247's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 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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