Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury

Completed · Phase 1/Phase 2

Conditions studied: Exercise, Fatigue, Physical Fitness, Traumatic Brain Injury

In brief

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.

Key facts

Study ID: NCT01294332
Run by: National Institutes of Health Clinical Center (CC)
People needed: 13
Starts: 2011-05-26
Expected to finish: 2014-02-11
Last updated by the study team: 2026-07-02

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Subjects are not eligible for participation in this research study if any of the following medical conditions that would impair aerobic capacity or the ability to engage in physical activity exist, including diseases of the cardiovascular (other than hypertension controlled by medication to below 140/90 mmHg), pulmonary, neurological, metabolic, or musculoskeletal systems such as:
Diagnosis or history of ischemic heart disease, including those with CABG and PTCA
Dilated or hypertrophic cardiomyopathy
Non-idiopathic cardiomyopathy
Uncontrolled hypertension, defined as a resting blood pressure above 140/90 mmHg
Diagnosis or history of right or left-sided heart failure or pulmonary hypertension
Diagnosis or history of restrictive or obstructive lung disease
Diagnosis or history of stroke
Type I or Type II Diabetes Mellitus
Diagnosis of chronic kidney disease, chronic liver disease, acute kidney injury or acute liver failure
Metastatic cancer active within the previous five years
Mitochondrial disease
On medications that would influence aerobic capacity, the ability to adapt to exercise training, or treadmill performance such as beta blockers or antiretroviral therapy
Active substance abuse including ETOH
Ongoing tobacco use (any use within the past six months)
Medical or Psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
Pregnancy
BMI greater than 40 kg/m(2)

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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