TBI (Traumatic Brain Injury)
Conditions
Keywords
Social engagement, Physical Activity, Sleep Quality, Traumatic Brain Injury, Veteran
Brief summary
This study will evaluate feasibility and preliminary effectiveness of a 10-week interdisciplinary and multimodal intervention that utilizes patient education, group discussion, and supervised exercise for Veterans with a history of traumatic brain injury (TBI). Primary outcomes include physical activity (PA), sleep quality, and community integration.
Detailed description
This randomized controlled trial will have a sample size of 24. Veterans between the ages of 18 and 65 in the Polytrauma and TBI program who are greater than 1 year post injury prior to entering the study, will be recruited. After randomization participants in the intervention group will complete a 10 week bout of multidisciplinary wellness education, group discussion, and supervised exercise. The intervention will occur weekly and last up to 2 hours. The control group will complete a 10week comprehensive health education program simultaneously. All measures will be collected again, post intervention. A follow-up collection will occur at 3 months post-intervention.
Interventions
BEHAVIORALInFuSE
Each session includes a 45-minute education and group discussion. A 60-minute exercise component then completes the session. Each topic was specifically picked and tailored to benefit Veterans with TBI. The education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians. Participants will be asked to participate in several learning activities. The activities are included to help improve understanding and promote group discussion. The exercise piece consists of a warm-up, endurance training (20-30 minutes), strengthening (15 minutes), balance/cognitive training (15 minutes), and a cool-down.
BEHAVIORALPatient Education/Group Discussion
Each week you will participate in a 1 hour health education class with other Veterans. Each topic was specifically picked and tailored for Veterans with TBI. These education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians. Participants will be asked to participate in several learning activities which are included to help improve understanding and promote group discussion.
Sponsors
Washington D.C. Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* TBI of at least mild severity using criteria related to disturbance of consciousness * Most recent TBI occurred \>1 year prior to consent process * Medically stable with physician approval to participate
Exclusion criteria
* Unable to provide informed consent and no proxy available * Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness * Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension) * Veteran is currently active in a skilled physical therapy program. * Veterans who meet or exceed American Heart Association and American College of Sports Medicine guidelines for physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Self-Efficacy Scale (ESES) | Change from baseline, after intervention (week 11), and 3 months after (week 24) | ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity. |
| Sleep Efficiency | Change from baseline, after intervention (week 11), and 3 months after (week 24) | Sleep efficiency is the total number of minutes of sleep divided by the number of minutes spent in bed. Sleep efficiency is measured by polysomnography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Gait Index (DGI) | Change from baseline, after intervention (week 11), and 3 months after (week 24) | A common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities. |
| Pittsburgh Sleep Quality Index (PSQI) | Change from baseline, after intervention (week 11), and 3 months after (week 24) | A self-reported measure to evaluate and monitor overall sleep quality. |
| Functional Capacity | Change from baseline, after intervention (week 11), and 3 months after (week 24) | Functional capacity is evaluated using a Bruce protocol treadmill maximal exertion stress test. The maximum amount of work performed by the participant on the treadmill is measured as metabolic equivalents (METs) |
| Mayo Portland Adaptability Index (MPAI-4) | Change from baseline, after intervention (week 11), and 3 months after (week 24) | A measure of self-reported quality of life, limitation severity, and community participation after TBI. |
| Community Reintegration of Service Members (CRIS) | Change from baseline, after intervention (week 11), and 3 months after (week 24) | A self-reported measure of the ability of service members to reintegrate after returning to civilian life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Brief Symptoms Inventory 18 (BSI-18) | Change from baseline, after intervention (week 11), and 3 months after (week 24) | A self-report measure of depression, anxiety, somatic concerns, and general distress. |
| California Verbal Learning Test-Second Edition (CVLT-II) | Change from baseline, after intervention (week 11), and 3 months after (week 24) | A widely used measure of verbal learning and memory using a multiple-trial list-learning task. |
| Post-Traumatic Stress Disorder Checklist (PCL) | Change from baseline, after intervention (week 11), and 3 months after (week 24) | A measure of the severity of PTSD related symptoms including intrusive thoughts, avoidance behavior, and arousal. |
Countries
United States
Outcome results
None listed