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

NCT02504866 | Terminated Results

• 2 other identifiers: 15016415-CC-0164
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Aerobic Exercise Training; Balance; TBI; Rapid-Resistive Exercise

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Function as Measured by Trail Making Test Part B (TMT-B)

  Trail Making Test (TMT) is a neuropsychological assessment of visual conceptual and visual motor tracking (involves motor speed and attention functions). Trail Making Test Part B (TMT-B) is associated with executive functioning and involves drawing a line connecting alternating numbers and letters in sequence (i.e., 1-A-2-B and so on). The time to complete the test is recorded. The time taken to complete the test was converted into standardized T-scores, representing a mean of 50 and a standard deviation of 10. Higher T-scores mean less cognitive deficits. The change in cognitive function was reported as the change in TMT-B T-scores across the 12 weeks (post minus pre intervention).

  Before (pre) and after (post) 12 weeks intervention

Study Arms (3)

Aerobic Exercise Intervention (AET)

EXPERIMENTAL

Participant with traumatic brain injury performed aerobic exercise on an elliptical trainer at a vigorous intensity for 30 minutes three times a week for 12 weeks

Other: Vigorous exercise

Rapid-Resistive Exercise Intervention (RET)

EXPERIMENTAL

Participant with traumatic brain injury performed rapid reciprocal exercise on an elliptical trainer at light to moderate intensity for 30 minutes three times a week for 12 weeks

Other: Light to moderate exercise

Waitlist Control (CON)

NO INTERVENTION

Participant with traumatic brain injury were waitlisted and did not perform any exercise intervention in the first 12 weeks. They were randomized to either AET or RET after the initial 12 weeks

Interventions

Vigorous exercise OTHER

Exercise training of vigorous intensity

Aerobic Exercise Intervention (AET)

Light to moderate exercise OTHER

Exercise training of light to moderate intensity

Rapid-Resistive Exercise Intervention (RET)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 to 79 inclusive
• Diagnosis of non-penetrating TBI
• Injury occurred at least 12 months prior to enrollment
• Physically inactive as identified by a physician
• Able to stand and walk independently and safely without any assistance
• Able to follow the study protocol
• Fluent in English and able to provide informed consent
• Ages 18 to 79 inclusive
• Physically inactive as identified by a physician
• Fluent in English

You may not qualify if:

• History of exercise intolerance
• History of heart disease
• History of pulmonary disease, other than controlled, non-exercise-induced asthma
• History of uncontrolled diabetes
• Uncontrolled hypertension, defined as a resting blood pressure \> 140/90 mmHg
• On medications that would influence aerobic capacity or treadmill performance such as beta blockers or antiretroviral therapy
• Active substance abuse including ETOH
• Presence of an injury to any extremity, or other medical condition that would affect motor function or the ability to perform the assessment or the exercise program, specifically balance problems due to vestibulopathy
• Unable to refrain from smoking at least 4 hours prior to exercise testing sessions
• Medical or psychological instability such that the subject could not reasonably be expected to fulfill the study requirements
• Pregnancy
• BMI \>40 kg/M(2) due to the limits of the treadmill, elliptical machine and MRI scanner
• Planning to make a change in medication or therapy during the enrollment period with the goal of improving mood, cognitive function or motor function
• Have any of the following contraindications to having an MRI scan:
• A ventriculo-peritoneal shunt

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 (3)

• Chin LM, Keyser RE, Dsurney J, Chan L. Improved cognitive performance following aerobic exercise training in people with traumatic brain injury. Arch Phys Med Rehabil. 2015 Apr;96(4):754-9. doi: 10.1016/j.apmr.2014.11.009. Epub 2014 Nov 26.

  PMID: 25433219 BACKGROUND

• Chin LM, Chan L, Woolstenhulme JG, Christensen EJ, Shenouda CN, Keyser RE. Improved Cardiorespiratory Fitness With Aerobic Exercise Training in Individuals With Traumatic Brain Injury. J Head Trauma Rehabil. 2015 Nov-Dec;30(6):382-90. doi: 10.1097/HTR.0000000000000062.

  PMID: 24901330 BACKGROUND

• Damiano DL, Zampieri C, Ge J, Acevedo A, Dsurney J. Effects of a rapid-resisted elliptical training program on motor, cognitive and neurobehavioral functioning in adults with chronic traumatic brain injury. Exp Brain Res. 2016 Aug;234(8):2245-52. doi: 10.1007/s00221-016-4630-8. Epub 2016 Mar 30.

  PMID: 27025506 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

Study was terminated early due to the COVID-19 pandemic. Enrollment of subjects were suspended, then major equipment changes and infection control updates precluded continuation during the COVID-19 pandemic. No subjects were enrolled into the healthy volunteer arm.

Results Point of Contact

• Title: Damiano, Diane
• Organization: Clinical Center

damianod@cc.nih.gov

+1 301 451 7544

Study Officials

• Diane L Damiano, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 22, 2015
• Study Start: December 15, 2016
• Primary Completion: February 4, 2020
• Study Completion: February 6, 2020
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Access Criteria: The Data Quality, Access, and Publication Committee will be responsible for procedures for Center for Neuroscience and Regenerative Medicine (CNRM) investigators to provide the necessary information for review of investigator qualifications and data usage. CNRM investigators requesting data must submit documentation of Institutional Review Board (IRB) approval of the research project with consideration of approvals across multiple sites if applicable. Only de-identified data can be requested. Use of the data is limited to the project that was proposed and approved. The data may not be reused for other projects or analyses, or redistributed to other investigators, repositories or databases, without written approval from the CNRM Data Quality, Access, and Publication Committee and the CNRM Informatics Core. At the completion of the analysis, the data and results must be entered into the CNRM repository.

Locations

US (1)