Effects of an Interdisciplinary Fitness and Social Engagement Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration

Conditions
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TBI (Traumatic Brain Injury)

Intervention / Treatment
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* Behavioral: InFuSE
* Behavioral: Patient Education/Group Discussion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InFuSE<br>Experimental group which will receive health education, group discussion, and supervised exercise. | Behavioral: InFuSE<br>* 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.<br>|
| Active Comparator: Patient Education/Group Discussion<br>Active control group which will receive health education and group discussion. | Behavioral: Patient Education/Group Discussion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social engagement, Physical Activity, Sleep Quality, Traumatic Brain Injury, Veteran