Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- TBI (Traumatic Brain Injury)
- Sponsor
- Washington D.C. Veterans Affairs Medical Center
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Exercise Self-Efficacy Scale (ESES)
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Exercise Self-Efficacy Scale (ESES)
Time Frame: 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
Time Frame: 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 Outcomes
- Dynamic Gait Index (DGI)(Change from baseline, after intervention (week 11), and 3 months after (week 24))
- Community Reintegration of Service Members (CRIS)(Change from baseline, after intervention (week 11), and 3 months after (week 24))
- Pittsburgh Sleep Quality Index (PSQI)(Change from baseline, after intervention (week 11), and 3 months after (week 24))
- Mayo Portland Adaptability Index (MPAI-4)(Change from baseline, after intervention (week 11), and 3 months after (week 24))
- Functional Capacity(Change from baseline, after intervention (week 11), and 3 months after (week 24))