Clinical trial NCT03152214: Physical Activity and Community Engagement (PACE) Among Returning Veterans
Official title: Physical Activity and Community Engagement (PACE) Among Returning Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reintegration
Keywords: Transition out of military
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Team Red, White, and Blue
First posted: 2017-05-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Over 2 million soldiers have deployed during the Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) conflicts. While the majority of veterans reintegrate successfully following deployment, a sizable minority return and face difficulties transitioning into civilian life. There is surprisingly little research on disseminable programs to facilitate reintegration, particularly outside of the formal VA healthcare system. The primary objective of this project is to develop and evaluate an integrated community- and exercise-based program that can be "prescribed" to augment existing transition assistance programs.

Detailed description: Founded in 2010, Team Red White and Blue (RWB) is a non-profit organization that aims to enrich the lives of veterans by enhancing their connection to their community. Initial survey findings support the mission by showing that involvement in Team RWB (1) increases connectivity; (2) helps bridge the civilian/military divide; and (3) improves well-being and life satisfaction.

Numerous trials indicate that engaging in exercise programs can improve mood and reduce symptoms of depression and anxiety (for review see Penedo and Dahn, 2005). Accordingly, prescribing a structured exercise program has the potential to facilitate involvement in RWB and a reduction in reintegration difficulties. Compared to other levels of exercise intensity, vigorous-intensity exercise has been associated with increases in well-being (Cox, Thomas, Hinton, Donahue, 2006), reductions in anxiety and depression (Balchin, Linde, Blackhurst, Rauch, \& Schönbächler, 2016; Cox, Thomas, Hinton, \& Donahue, 2004; Katula, Blissmer, \& McAuley, 1999) and improvements in quality of life (Ostman, Jewiss, \& Smart, 2016). According to the American College of Sports Medicine (ACSM), high intensity exercise methods are the leading trend in the fitness industry (Thompson, 2013). Importantly, high intensity exercise programs have gained increasing popularity particularly within military units (Haddock, Poston, Heinrich, Jahnke, \& Jitnarin, 2016).

This study aims to provide a pilot test of (1) the acceptability and effectiveness of RWB for veterans transitioning out of the military and (2) the effectiveness of a vigorous-intensity aerobic exercise prescription for enhancing the efficacy of RWB. To this end, the study will be a randomized controlled trial (RCT) that involves 75 veterans discharged from the US Army at Fort Hood who will be assigned to: 1) 8-weeks of vigorous-intensity aerobic exercise in addition to participation in a community-based program (Team RWB) or (2) 8-weeks of participation in Team RWB alone or (3) 8-weeks on a waitlist.

Eligibility criteria: Inclusion Criteria:

* OEF/OIF/OND veteran
* Discharged from the US Army within/up to 12 months ago
* Endorse at least moderate difficulty with reintegration (a total score of at least 1.5 on the M2C-Q and a score of 2 on item #14)
* Use or have access to an Apple iPhone
* Has participated in less than 75 minutes of vigorous-intensity exercise per week over the last two weeks
* Understanding and willingness to comply to a 9-week study protocol

Exclusion Criteria:

* Condition or injury which would prevent exercise\*
* Insufficient command of the English language

Each veteran will complete the PAR-Q as part of the screening procedure in order to check for any condition/injury which would render exercise harmful. Each veteran will also have undergone a routine physical with medical staff prior to discharge from the U.S. Army. Thus, the veteran should have knowledge of a condition or injury which could be problematic. If such a risk is present, the veteran will be excluded from the study. Veterans will be excluded if a doctor has said that they have a heart condition and should not do physical activity or if they know of any other reason why they should not engage in physical activity. Veterans who are unsure if they are able to engage in physical activity will have to have signed approval from a physical.

Primary outcomes:
measure: Level of Reintegration Difficulties
timeFrame: 9 weeks
Secondary outcomes:
measure: Acceptability of the Intervention
timeFrame: 9 weeks
measure: Meaning in life
timeFrame: 9 weeks
measure: Depressive Symptoms
timeFrame: 9 weeks
measure: Life Satisfaction
timeFrame: 9 weeks
measure: Life Enrichment
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Scarlett O Baird, M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Jasper A Smits, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: