Clinical Trials Directory

Trials / Terminated

TerminatedNCT03160313

Effects of an Interdisciplinary Fitness and Social Engagement Intervention

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Washington D.C. Veterans Affairs Medical Center · Federal
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALInFuSEEach 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.
BEHAVIORALPatient 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.

Timeline

Start date
2016-06-01
Primary completion
2018-12-01
Completion
2018-12-01
First posted
2017-05-19
Last updated
2024-07-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03160313. Inclusion in this directory is not an endorsement.