Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury
Public ClinicalTrials.gov record NCT01294332. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Effect of Aerobic Exercise Training on Cardiorespiratory Fitness in Patients With Traumatic Brain Injury
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall quality of life), tests of thinking and a treadmill exercise test....
Study identification
- NCT ID
- NCT01294332
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 13 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 25, 2011
- Primary completion
- Dec 30, 2013
- Completion
- Feb 10, 2014
- Last update posted
- Sep 7, 2026
2011 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01294332, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 7, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01294332 live on ClinicalTrials.gov.