Physical Activity and Community Engagement (PACE) Among Returning Veterans

NCT03152214 | Completed

• 1 other identifier: 2017-03-0109
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Reintegration

Keywords

Transition out of military

Outcome Measures

Primary Outcomes (1)

• Level of Reintegration Difficulties

  The Military to Civilian Questionnaire (M2C-Q) is a 16-item self-report measure of post deployment community reintegration difficulty. The M2C-Q assesses a number of theoretically related domains (e.g., overall mental health, probably PTSD, separate rating of difficulty readjusting to civilian life; Sayer et al., 2011).

  9 weeks

Secondary Outcomes (5)

• Acceptability of the Intervention

  9 weeks

• Meaning in life

  9 weeks

• Depressive Symptoms

  9 weeks

• Life Satisfaction

  9 weeks

• Life Enrichment

  9 weeks

Study Arms (3)

Team RWB + Vigorous Intensity Aerobic Exercise

EXPERIMENTAL

Participants assigned to the integrated arm will be prescribed the following for the course of 8 weeks: * 1 session of exercise counseling * 3 weekly 25-minute sessions of vigorous intensity aerobic exercise * 1 weekly Team RWB event * 4 biweekly assessments Participants will also complete an online assessment at week 9 to provide follow-up data.

Other: Vigorous Intensity Aerobic Exercise and Community Engagement

Team RWB

ACTIVE COMPARATOR

Participants assigned to the Team RWB arm will be prescribed the following for the course of 8 weeks: * 1 weekly Team RWB event * 4 biweekly assessments Participants will also complete an online assessment at week 9 to provide follow-up data.

Other: Community Engagement

Waitlist

NO INTERVENTION

Participants assigned to the waitlist arm will be prescribed the following for the course of 8 weeks: • 4 biweekly assessments Participants will also complete an online assessment at week 9 to provide follow-up data.

Interventions

Vigorous Intensity Aerobic Exercise and Community Engagement OTHER

Each veteran will be provided with an Apple watch for the duration of the study. Research staff will use the resultant data to monitor the veteran's activity level. Veterans will be asked to complete three 25-minute sessions of vigorous intensity aerobic exercise per week (either running, cycling, rowing, or elliptical workouts). Data collected will include the number of minutes exercised and the heartrate level (77-85% maximum heart rate). Any exercise session of 25 minutes at \> 76% of maximum heart rate will be characterized as 1 completed session of vigorous-intensity exercise. Veterans will enter the activity, minutes exercised, average heartrate, and perceived exertion into REDCap. Community engagement will involve attending at least one Team RWB event per week through the Austin or Killeen chapters. This could be a weekly running group, hike, or community service project-among other activities. Veterans will enter whether or not they attended a Team RWB event on REDCap.

Team RWB + Vigorous Intensity Aerobic Exercise

Community Engagement OTHER

Veterans in the study will receive a monthly calendar of Team RWB events upon assignment. Veterans will be able to participate in any Team RWB event located in Austin or Killeen. Veterans will be asked to attend at least one Team RWB event. This could be a weekly running group, hike, or community service project- among other activities. Veterans will enter whether or not they attended a Team RWB event on the REDCap exercise adherence surveys.

Team RWB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead
• Team Red, White, and Blue: collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Study Officials

• Scarlett O Baird, M.A.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Jasper A Smits, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 12, 2017
• Study Start: September 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Locations

US (1)