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

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

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.

Study Overview

• Status: Terminated
• Conditions: TBI (Traumatic Brain Injury)
• Intervention / Treatment: Behavioral: InFuSE; Behavioral: Patient Education/Group Discussion

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Washington DC VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
California Verbal Learning Test-Second Edition (CVLT-II)	A widely used measure of verbal learning and memory using a multiple-trial list-learning task.	Change from baseline, after intervention (week 11), and 3 months after (week 24)
Brief Symptoms Inventory 18 (BSI-18)	A self-report measure of depression, anxiety, somatic concerns, and general distress.	Change from baseline, after intervention (week 11), and 3 months after (week 24)
Post-Traumatic Stress Disorder Checklist (PCL)	A measure of the severity of PTSD related symptoms including intrusive thoughts, avoidance behavior, and arousal.	Change from baseline, after intervention (week 11), and 3 months after (week 24)

Collaborators and Investigators

• Sponsor: Washington D.C. Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Sleep Quality; Veteran; Traumatic Brain Injury; Social engagement
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 01798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No