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

NCT01294332 | Completed Phase 1

• 2 other identifiers: 11008811-CC-0088
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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 questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall quality of life), tests of thinking and a treadmill exercise test.

Conditions

Exercise; Fatigue; Physical Fitness; Traumatic Brain Injury

Keywords

Cognition; TBI; Mood; Aerobic Exercise Training; Cardiorespiratory Fitness

Outcome Measures

Primary Outcomes (1)

• Change in peak oxygen consumption

  The peak VO2 as measured by gas exchange during a cardiopulmonary exercise test to volitional exhaustion.

  Pre and post

Study Arms (1)

Exercise

EXPERIMENTAL

Aerobic exercise performed for 12 weeks

Other: Aerobic Exercise Training

Interventions

Aerobic Exercise Training OTHER

supervised exercise on the treadmill at target heart rate range for 12 weeks, 3 times a week for 30 minutes.

Exercise

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of non-penetrating mild, moderate, or severe TBI
• Injury occurred at least 6 months prior to enrollment
• Age 21-45 years
• Physically inactive as identified by a physician.
• Able to stand and walk on a treadmill independently and safely without assistance
• Able to follow the study protocol
• Fluent in English and able to provide informed consent
• Willing and safely able to forego starting or changing an exercise program or treatments that would potentially alter cardiorespiratory capacity or ability to exercise and/or treatment for mood disorders

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)

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Chin LMK, Chan L, Drinkard B, Keyser RE. Oxygen uptake on-kinetics before and after aerobic exercise training in individuals with traumatic brain injury. Disabil Rehabil. 2019 Dec;41(24):2949-2957. doi: 10.1080/09638288.2018.1483432. Epub 2018 Jun 30.

  PMID: 29961351 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Motor Activity; Fatigue; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Leighton Chan, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 11, 2011
• Study Start: May 26, 2011
• Primary Completion: December 31, 2013
• Study Completion: February 11, 2014
• Last Updated: April 8, 2026

Record last verified: 2025-12-09

Locations

US (1)