Effects of an Interdisciplinary Fitness and Social Engagement Intervention

TBI (Traumatic Brain Injury) Clinical Trial

— InFuSe  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03160313
• Other study ID #: 01798
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Washington D.C. Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Washington DC VA Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Washington D.C. Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)