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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InFuSE | Experimental | Experimental group which will receive health education, group discussion, and supervised exercise. |
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| Patient Education/Group Discussion | Active Comparator | Active control group which will receive health education and group discussion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InFuSE | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Self-Efficacy Scale (ESES) | ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity. | Change from baseline, after intervention (week 11), and 3 months after (week 24) |
| Sleep Efficiency | 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. | Change from baseline, after intervention (week 11), and 3 months after (week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Capacity | 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) | Change from baseline, after intervention (week 11), and 3 months after (week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| California Verbal Learning Test-Second Edition (CVLT-II) | A widely used measure of verbal learning and memory using a multiple-trial list-learning task. | Change from baseline, after intervention (week 11), and 3 months after (week 24) |
| Brief Symptoms Inventory 18 (BSI-18) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington DC VA Medical Center | Washington D.C. | District of Columbia | 20422 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D009043 | Motor Activity |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
| Patient Education/Group Discussion | Behavioral | 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. |
|
| Dynamic Gait Index (DGI) |
A common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities. |
| Change from baseline, after intervention (week 11), and 3 months after (week 24) |
| Pittsburgh Sleep Quality Index (PSQI) | A self-reported measure to evaluate and monitor overall sleep quality. | Change from baseline, after intervention (week 11), and 3 months after (week 24) |
| Mayo Portland Adaptability Index (MPAI-4) | A measure of self-reported quality of life, limitation severity, and community participation after TBI. | Change from baseline, after intervention (week 11), and 3 months after (week 24) |
| Community Reintegration of Service Members (CRIS) | A self-reported measure of the ability of service members to reintegrate after returning to civilian life. | 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. |
| Change from baseline, after intervention (week 11), and 3 months after (week 24) |
| Post-Traumatic Stress Disorder Checklist (PCL) | A measure of the severity of PTSD related symptoms including intrusive thoughts, avoidance behavior, and arousal. | Change from baseline, after intervention (week 11), and 3 months after (week 24) |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |