Brain InjuriesBITEEENCT03256643
Brain Injury Therapy of Exercise and Enriched Environment
A study testing Exercise, Delayed Exercise and Exercise and enrichment in people with Brain Injuries, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Exercise, Delayed Exercise and Exercise and enrichment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic brain injury (TBI) person
- 1 to 15 year post-TBI
- Initial Glascow Coma SCale (GCS) of < or = 12
- 18-75 years old
- able to perform standardized exercise program
Who cannot join
- Inability to walk independently without assistive aids.
- Severe cardiovascular limitations limiting exercise of up to 5 metabolic equivalents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive and Physical Effects of Exercise or Exercise With Enrichment on People With TBI
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.
Read the detailed description
Traumatic brain injury (TBI) results in long-lasting physical and cognitive deficits. 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 environmental enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk on 8 different cultures. Individuals will be evaluated using neuropsychological and physical tests before and after the intervention. Testing will consist of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trailmaking Test (TMT), Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Quality of Life in Brain Injury Questionnaire (QOLIBRI), 10 meter walk, and the NIH Toolbox Standing Balance Test. Initial testing will include the Disability Rating Scale to help balance groups (after random assignment) in terms of baseline ability.
In rodents, exercise or an enriched environment after TBI improve cognitive function and motor function and the combination results in even greater improvement. The mechanism of cognitive improvement from exercise or environmental enrichment relates to increases in brain derived neurotrophic factor and neurogenesis in the hippocampus. An additional possible mechanism of the positive effects of exercise or enrichment is a reduction in inflammation. Our hypothesis is that exercise or exercise with enrichment will result in better motor performance and improved cognitive ability.
- Conditions
- Brain Injuries
- Being tested
- Exercise, Delayed Exercise, Exercise and enrichment
- Keywords
- traumatic brain injury, brain contusion, craniocerebral trauma, exercise therapy, chronic brain injury, environment impact, cognitive therapy, health facility environment
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Brain Contusion, Craniocerebral Trauma, Brain Injury, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
Delayed ExerciseBehavioural
People will be tested up to 40 weeks after beginning the intervention.
Exercise and enrichmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program. Receives: 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. Receives: 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. Receives: Behavioral: Exercise and enrichment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 9 weeks.
Secondary outcomes (1)
Quality of Life in Brain Injury Questionnaire
Quality of Life in Brain Injury Questionnaire is a thirty-seven question self-reported measure of overall patient health.
Measured: Change from Baseline at 9 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 May 2016
- Primary completion1 Jul 2018
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay M Meythaler, Wayne State University
- Investigators
- Jean Peduzzi-Nelson, Ph.D., Study director, Wayne State University I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256643
- Sponsor's protocol ID
- 123
- Acronym
- BITEEE
- Status last verified
- Mar 2020
- First submitted
- 9 Dec 2014
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25228861Bondi 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.
PubMed 24555571Fischer 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.
PubMed 17591227Gomez-Pinilla F, Hillman C. The influence of exercise on cognitive abilities. Compr Physiol. 2013 Jan;3(1):403-28. doi: 10.1002/cphy.c110063.
PubMed 23720292Piao 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.
PubMed 23313314
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Physical Effects of Exercise or Exercise With Enrichment on People With TBI
- ClinicalTrials.gov ID
- NCT03256643
- Acronym / sponsor ID
- BITEEE / 123
- Conditions
- Brain Injuries
- Keywords
- traumatic brain injury, brain contusion, craniocerebral trauma, exercise therapy, chronic brain injury, environment impact, cognitive therapy, health facility environment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Traumatic brain injury (TBI) results in long-lasting physical and cognitive deficits. 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 environmental enrichment will consist of a cultural educational program that will include ethnic food, music, slides and a talk on 8 different cultures. Individuals will be evaluated using neuropsychological and physical tests before and after the intervention. Testing will consist of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Trailmaking Test (TMT), Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Quality of Life in Brain Injury Questionnaire (QOLIBRI), 10 meter walk, and the NIH Toolbox Standing Balance Test. Initial testing will include the Disability Rating Scale to help balance groups (after random assignment) in terms of baseline ability.
In rodents, exercise or an enriched environment after TBI improve cognitive function and motor function and the combination results in even greater improvement. The mechanism of cognitive improvement from exercise or environmental enrichment relates to increases in brain derived neurotrophic factor and neurogenesis in the hippocampus. An additional possible mechanism of the positive effects of exercise or enrichment is a reduction in inflammation. Our hypothesis is that exercise or exercise with enrichment will result in better motor performance and improved cognitive ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseExercise is the intervention. People be tested before the start of, and after the end of the eight (8) week exercise program. |
| Delayed Exercise | Experimental | Behavioral: Delayed ExerciseDelayed 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. |
| Exercise and Enrichment | Experimental | Behavioral: Exercise and enrichmentExercise and Enrichment Group is the intervention. The group will be tested at the beginning and end of their exercise/enrichment program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Traumatic brain injury (TBI) person
- 1 to 15 year post-TBI
- Initial Glascow Coma SCale (GCS) of < or = 12
- 18-75 years old
- able to perform standardized exercise program
Key exclusion criteria (2 listed)
- Inability to walk independently without assistive aids.
- Severe cardiovascular limitations limiting exercise of up to 5 metabolic equivalents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise 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. | Behavioural | Exercise |
| Delayed ExercisePeople will be tested up to 40 weeks after beginning the intervention. | Behavioural | Delayed Exercise |
| Exercise and enrichmentExercise 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. | Behavioural | Exercise and Enrichment |
Primary outcome
Trail Making Part B
Time frame: Change from Baseline at 9 weeks.
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.
1 secondary outcome
Quality of Life in Brain Injury Questionnaire
Time frame: Change from Baseline at 9 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Background: PubMed 25228861Alwis 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.
- Background: PubMed 24555571Bondi 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.
- Background: PubMed 17591227Fischer 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.
- Background: PubMed 23720292Gomez-Pinilla F, Hillman C. The influence of exercise on cognitive abilities. Compr Physiol. 2013 Jan;3(1):403-28. doi: 10.1002/cphy.c110063.
- Background: PubMed 23313314Piao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Peduzzi-Nelson, Ph.D. study director
Wayne State University I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Delayed Exercise and Exercise and enrichment in people with Brain Injuries, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trail Making Part B (time frame: Change from Baseline at 9 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03256643, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.