Brain Injury Therapy of Exercise and Enriched Environment

NCT03256643 | Unknown

• 1 other identifier: 123
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether exercise or exercise with enrichment is beneficial in individuals who previously had a head injury. The enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk. A series of tests that measure mental function and balance will be done before and after the exercise or the exercise/enrichment program will be done to measure efficacy.

Conditions

Brain Injuries

Keywords

traumatic brain injury; brain contusion; craniocerebral trauma; exercise therapy; chronic brain injury; environment impact; cognitive therapy; health facility environment

Outcome Measures

Primary Outcomes (1)

• Trail Making Part B

  Trail Making test is a measure of visual conceptual and visuomotor tracking, attention, and maintenance of cognitive set-shifting that is known to be highly sensitive to brain damage.

  Change from Baseline at 9 weeks.

Secondary Outcomes (1)

• Quality of Life in Brain Injury Questionnaire

  Change from Baseline at 9 weeks.

Other Outcomes (4)

• Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT)

  Change from Baseline at 9 weeks.

• Ten Minute Walk

  Change from Baseline at 9 weeks.

• NIH Toolbox Standing Balance Test

  Change from Baseline and at 9 weeks.

Study Arms (3)

Exercise

EXPERIMENTAL

Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program.

Behavioral: Exercise

Delayed Exercise

EXPERIMENTAL

Delayed Exercise Group will have exercise as intervention. People be tested before the start of, and after the end of the eight (8) weeks then after exercise intervention.

Behavioral: Delayed Exercise

Exercise and Enrichment

EXPERIMENTAL

Exercise and Enrichment Group is the intervention. The group will be tested at the beginning and end of their exercise/enrichment program.

Behavioral: Exercise and enrichment

Interventions

Exercise BEHAVIORAL

Exercise intervention will consist of 8 exercise classes and exercises at home. A booklet will be given to each person that has a description and photograph of each exercise that designed to work on core strength and balance.

Exercise

Delayed Exercise BEHAVIORAL

People will be tested up to 40 weeks after beginning the intervention.

Delayed Exercise

Exercise and enrichment BEHAVIORAL

Exercise and enrichment will consist of the same exercise program described for the exercise intervention. The enrichment protocol consisting of cultural educational program will take place during the exercises and breaks for this group.

Exercise and Enrichment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Traumatic brain injury (TBI) person
• to 15 year post-TBI
• Initial Glascow Coma SCale (GCS) of \< or = 12
• years old
• able to perform standardized exercise program

You may not qualify if:

• Inability to walk independently without assistive aids.
• Severe cardiovascular limitations limiting exercise of up to 5 metabolic equivalents.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Oakwood Heritage

Taylor, Michigan, 48180, United States

Location

Related Publications (5)

• Alwis DS, Rajan R. Environmental enrichment and the sensory brain: the role of enrichment in remediating brain injury. Front Syst Neurosci. 2014 Sep 2;8:156. doi: 10.3389/fnsys.2014.00156. eCollection 2014.

  PMID: 25228861 BACKGROUND

• Bondi CO, Klitsch KC, Leary JB, Kline AE. Environmental enrichment as a viable neurorehabilitation strategy for experimental traumatic brain injury. J Neurotrauma. 2014 May 15;31(10):873-88. doi: 10.1089/neu.2014.3328. Epub 2014 Apr 17.

  PMID: 24555571 BACKGROUND

• Fischer FR, Peduzzi JD. Functional recovery in rats with chronic spinal cord injuries after exposure to an enriched environment. J Spinal Cord Med. 2007;30(2):147-55. doi: 10.1080/10790268.2007.11753926.

  PMID: 17591227 BACKGROUND

• Gomez-Pinilla F, Hillman C. The influence of exercise on cognitive abilities. Compr Physiol. 2013 Jan;3(1):403-28. doi: 10.1002/cphy.c110063.

  PMID: 23720292 BACKGROUND

• Piao CS, Stoica BA, Wu J, Sabirzhanov B, Zhao Z, Cabatbat R, Loane DJ, Faden AI. Late exercise reduces neuroinflammation and cognitive dysfunction after traumatic brain injury. Neurobiol Dis. 2013 Jun;54:252-63. doi: 10.1016/j.nbd.2012.12.017. Epub 2013 Jan 8.

  PMID: 23313314 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Brain Contusion; Craniocerebral Trauma; Brain Injury, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Contusions; Wounds, Nonpenetrating; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jean Peduzzi-Nelson, Ph.D.

  Wayne State University I

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine with Tenure

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: August 22, 2017
• Study Start: May 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)