TBI (Traumatic Brain Injury)InFuSeNCT03160313
Effects of an Interdisciplinary Fitness and Social Engagement Intervention
A study testing InFuSE and Patient Education/Group Discussion in people with TBI (Traumatic Brain Injury), run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- InFuSE and Patient Education/Group Discussion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
About this study
Official title: 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.
Read the 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.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- InFuSE, Patient Education/Group Discussion
- Keywords
- Social engagement, Physical Activity, Sleep Quality, Traumatic Brain Injury, Veteran
- Medical subject headings
- Brain Injuries, Traumatic, Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InFuSEBehavioural
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 DiscussionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| InFuSE | Experimental | Experimental group which will receive health education, group discussion, and supervised exercise. Receives: Behavioral: InFuSE |
| Patient Education/Group Discussion | Active comparator | Active control group which will receive health education and group discussion. Receives: Behavioral: Patient Education/Group Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Self-Efficacy Scale (ESES)
ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity.
Measured: 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.
Measured: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Secondary outcomes (5)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Jun 2016
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160313
- Sponsor's protocol ID
- 01798
- Acronym
- InFuSe
- Status last verified
- Jul 2024
- First submitted
- 28 Mar 2017
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration
- ClinicalTrials.gov ID
- NCT03160313
- Acronym / sponsor ID
- InFuSe / 01798
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- Social engagement, Physical Activity, Sleep Quality, Traumatic Brain Injury, Veteran
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InFuSE | Experimental | Behavioral: InFuSEExperimental group which will receive health education, group discussion, and supervised exercise. |
| Patient Education/Group Discussion | Active comparator | Behavioral: Patient Education/Group DiscussionActive control group which will receive health education and group discussion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InFuSEEach 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. | Behavioural | InFuSE |
| Patient Education/Group DiscussionEach 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. | Behavioural | Patient Education/Group Discussion |
Primary outcome
Exercise Self-Efficacy Scale (ESES)
Time frame: 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
Time frame: 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.
5 secondary outcomes
Functional Capacity
Time frame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Dynamic Gait Index (DGI)
Time frame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Mayo Portland Adaptability Index (MPAI-4)
Time frame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Community Reintegration of Service Members (CRIS)
Time frame: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InFuSE and Patient Education/Group Discussion in people with TBI (Traumatic Brain Injury), run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Self-Efficacy Scale (ESES) (time frame: Change from baseline, after intervention (week 11), and 3 months after (week 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.