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临床试验/NCT03152214
NCT03152214已完成不适用

Physical Activity and Community Engagement (PACE) Among Returning Veterans

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Level of Reintegration Difficulties

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Level of Reintegration Difficulties

时间窗: 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).

次要结局

  • Acceptability of the Intervention(9 weeks)
  • Meaning in life(9 weeks)
  • Depressive Symptoms(9 weeks)
  • Life Enrichment(9 weeks)
  • Life Satisfaction(9 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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