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

Primary Purpose

TBI (Traumatic Brain Injury)

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
InFuSE
Patient Education/Group Discussion
Sponsored by
Washington D.C. Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TBI (Traumatic Brain Injury) focused on measuring Social engagement, Physical Activity, Sleep Quality, Traumatic Brain Injury, Veteran

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Washington DC VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

InFuSE

Patient Education/Group Discussion

Arm Description

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

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

Outcomes

Primary Outcome Measures

Exercise Self-Efficacy Scale (ESES)
ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity.
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2017
Last Updated
August 31, 2018
Sponsor
Washington D.C. Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03160313
Brief Title
Effects of an Interdisciplinary Fitness and Social Engagement Intervention
Acronym
InFuSe
Official Title
Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington D.C. Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury)
Keywords
Social engagement, Physical Activity, Sleep Quality, Traumatic Brain Injury, Veteran

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
InFuSE
Arm Type
Experimental
Arm Description
Experimental group which will receive health education, group discussion, and supervised exercise.
Arm Title
Patient Education/Group Discussion
Arm Type
Active Comparator
Arm Description
Active control group which will receive health education and group discussion.
Intervention Type
Behavioral
Intervention Name(s)
InFuSE
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Education/Group Discussion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise Self-Efficacy Scale (ESES)
Description
ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity.
Time Frame
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Title
Sleep Efficiency
Description
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.
Time Frame
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Secondary Outcome Measure Information:
Title
Functional Capacity
Description
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)
Time Frame
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Title
Dynamic Gait Index (DGI)
Description
A common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities.
Time Frame
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
A self-reported measure to evaluate and monitor overall sleep quality.
Time Frame
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Title
Mayo Portland Adaptability Index (MPAI-4)
Description
A measure of self-reported quality of life, limitation severity, and community participation after TBI.
Time Frame
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Title
Community Reintegration of Service Members (CRIS)
Description
A self-reported measure of the ability of service members to reintegrate after returning to civilian life.
Time Frame
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Other Pre-specified Outcome Measures:
Title
California Verbal Learning Test-Second Edition (CVLT-II)
Description
A widely used measure of verbal learning and memory using a multiple-trial list-learning task.
Time Frame
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Title
Brief Symptoms Inventory 18 (BSI-18)
Description
A self-report measure of depression, anxiety, somatic concerns, and general distress.
Time Frame
Change from baseline, after intervention (week 11), and 3 months after (week 24)
Title
Post-Traumatic Stress Disorder Checklist (PCL)
Description
A measure of the severity of PTSD related symptoms including intrusive thoughts, avoidance behavior, and arousal.
Time Frame
Change from baseline, after intervention (week 11), and 3 months after (week 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Washington DC VA Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of an Interdisciplinary Fitness and Social Engagement Intervention

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