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Effect of Exercise Training on Physical, Cognitive, and Behavioral Function in People With TBI

NCT02504866 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-18

Study results available
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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

Conditions

  • Traumatic Brain Injury (TBI)

Interventions

OTHER

Vigorous exercise

Exercise training of vigorous intensity

OTHER

Light to moderate exercise

Exercise training of light to moderate intensity

Sponsors & Collaborators

  • Center for Neuroscience and Regenerative Medicine (CNRM)

    collaborator FED

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Diane L Damiano, Ph.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2020-02-04
Completion
2020-02-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504866 on ClinicalTrials.gov