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NCT01294332 · ClinicalTrials.gov registry record · Phase 1
Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01294332: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT01294332 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01294332, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
Background: \- 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. Objectives: \- To examine the effect of an aerobic treadmill walking exercise program on physical fitness, fatigue, and mood in people with TBI. Eligibility: \- 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. Design: * 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 questio
Primary Outcome
The peak VO2 as measured by gas exchange during a cardiopulmonary exercise test to volitional exhaustion.
Interventions
- OTHER Aerobic Exercise Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-05-26 |
| Est. Completion | 2014-02-11 |
| Phase | Phase 1 |
What the finished NCT01294332 record still lists
NCT01294332 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Aerobic Exercise Training is the first listed.
NCT01294332 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01294332 about?
NCT01294332 is a clinical study titled "Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury". Background: \- 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 trea...
What is the current status of trial NCT01294332?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-05-26. Estimated completion is 2014-02-11.
What interventions are being tested in trial NCT01294332?
The interventions under investigation include: Aerobic Exercise Training (OTHER).
Who is sponsoring clinical trial NCT01294332?
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 NCT01294332's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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