Effects of an Interdisciplinary Fitness and Social Engagement Intervention (InFuSe)

Washington D.C. Veterans Affairs Medical Center

Status: Terminated

Conditions: TBI (Traumatic Brain Injury)

Treatments: Behavioral: InFuSE; Behavioral: Patient Education/Group Discussion

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03160313

01798

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

InFuSE

Experimental group

Description:

Experimental group which will receive health education, group discussion, and supervised exercise.

Treatment:

Behavioral: InFuSE

Patient Education/Group Discussion

Active Comparator group

Description:

Active control group which will receive health education and group discussion.

Treatment:

Behavioral: Patient Education/Group Discussion