Clinical trial NCT03160313: Effects of an Interdisciplinary Fitness and Social Engagement Intervention
Official title: Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Keywords: Social engagement
Physical Activity
Sleep Quality
Traumatic Brain Injury
Veteran
Lead sponsor: Washington D.C. Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2017-05-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Exercise Self-Efficacy Scale (ESES)
timeFrame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
measure: Sleep Efficiency
timeFrame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Secondary outcomes:
measure: Functional Capacity
timeFrame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
measure: Dynamic Gait Index (DGI)
timeFrame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
measure: Mayo Portland Adaptability Index (MPAI-4)
timeFrame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
measure: Community Reintegration of Service Members (CRIS)
timeFrame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Other outcomes:
measure: California Verbal Learning Test-Second Edition (CVLT-II)
timeFrame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
measure: Brief Symptoms Inventory 18 (BSI-18)
timeFrame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
measure: Post-Traumatic Stress Disorder Checklist (PCL)
timeFrame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
Study officials:
References: