ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03152214
Previous Study | Return to List | Next Study

Physical Activity and Community Engagement (PACE) Among Returning Veterans (PACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03152214
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Team Red, White, and Blue
Information provided by (Responsible Party):
University of Texas at Austin

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.

Condition or disease Intervention/treatment Phase
Reintegration Other: Vigorous Intensity Aerobic Exercise and Community Engagement Other: Community Engagement Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Physical Activity and Community Engagement (PACE) Among Returning Veterans
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Team RWB + Vigorous Intensity Aerobic Exercise

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

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.


Active Comparator: Team RWB

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
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.

No Intervention: Waitlist

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.




Primary Outcome Measures :
  1. Level of Reintegration Difficulties [ Time Frame: 9 weeks ]
    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).


Secondary Outcome Measures :
  1. Acceptability of the Intervention [ Time Frame: 9 weeks ]
    This will be assessed by looking at adherence to exercise or Team RWB events. The investigators will also include a measure to assess veterans' perceptions of the exercise program and of Team RWB in terms of likelihood of future engagement, program likeability, and perceived benefits of the intervention.

  2. Meaning in life [ Time Frame: 9 weeks ]
    The Meaning in Life Questionnaire (MLQ) is a 10-item measure designed to measure two dimensions of meaning in life: 1) presence of meaning (how much participants feel that their lives have meaning) and 2) search for meaning (how much participants strive to find meaning in their lives).

  3. Depressive Symptoms [ Time Frame: 9 weeks ]
    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure designed to screen for and monitor the severity of depressive symptoms.

  4. Life Satisfaction [ Time Frame: 9 weeks ]
    The Satisfaction with Life Scale (SWLS) is a 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life (Diener, Emmons, Larsen, & Griffin, 1985).

  5. Life Enrichment [ Time Frame: 9 weeks ]
    The Team RWB Enriched Life Scale (ELS) is a 48-item instrument designed to measure an "enriched" life defined as positive health, genuine relationships, and sense of individual and shared purpose.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152214


Contacts
Contact: Scarlett O Baird, M.A. 9729226889 scarlett.baird@utexas.edu
Contact: Haley Conroy 512-471-1117 haleyeconroy@utexas.edu

Locations
United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Scarlett Baird, M.A.    972-922-6889    scarlett.baird@utexas.edu   
Contact: Christy Amador, M.Ed.    512 471 7694    cdutcher@austin.utexas.edu   
Sponsors and Collaborators
University of Texas at Austin
Team Red, White, and Blue
Investigators
Principal Investigator: Scarlett O Baird, M.A. University of Texas at Austin
Principal Investigator: Jasper A Smits, Ph.D. University of Texas at Austin

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03152214     History of Changes
Other Study ID Numbers: 2017-03-0109
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Texas at Austin:
Transition out of military