Effects of an Interdisciplinary Fitness and Social Engagement Intervention

Not Applicable

Terminated

• Conditions: TBI (Traumatic Brain Injury)
• Interventions: Behavioral: Patient Education/Group Discussion; Behavioral: InFuSE

• Registration Number: NCT03160313
• Lead Sponsor: Washington D.C. Veterans Affairs Medical Center

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.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-19
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Education/Group Discussion	Patient Education/Group Discussion	Active control group which will receive health education and group discussion.
InFuSE	InFuSE	Experimental group which will receive health education, group discussion, and supervised exercise.

Primary Outcome Measures

Name	Time	Method
Exercise Self-Efficacy Scale (ESES)	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	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 Outcome Measures

Name	Time	Method
Dynamic Gait Index (DGI)	Change from baseline, after intervention (week 11), and 3 months after (week 24)	A common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities.
Pittsburgh Sleep Quality Index (PSQI)	Change from baseline, after intervention (week 11), and 3 months after (week 24)	A self-reported measure to evaluate and monitor overall sleep quality.
Mayo Portland Adaptability Index (MPAI-4)	Change from baseline, after intervention (week 11), and 3 months after (week 24)	A measure of self-reported quality of life, limitation severity, and community participation after TBI.
Functional Capacity	Change from baseline, after intervention (week 11), and 3 months after (week 24)	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)
Community Reintegration of Service Members (CRIS)	Change from baseline, after intervention (week 11), and 3 months after (week 24)	A self-reported measure of the ability of service members to reintegrate after returning to civilian life.

Trial Locations

Locations (1)

Washington DC VA Medical Center; 🇺🇸 Washington, District of Columbia, United States