Exercise: A Novel Treatment for Combat PTSD
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Efficacy as measured by a reduction in symptoms of posttraumatic stress disorder.
研究概览
简要总结
The primary objective of this pilot intervention study is to examine the efficacy of exercise for reducing the symptoms of posttraumatic stress disorder (PTSD) and other psychiatric and somatic symptoms. The sample will be composed of veterans aged 18-65 with combat-related PTSD (N = 40). Participants will be randomly assigned to one of two groups. Participants in the exercise training group (n = 20) will receive three 60-75 minute sessions per week of combination aerobic and resistance training for eight weeks. In the control stretching group, participants (n = 20) will receive training in whole-body flexibility three times per week for eight weeks. Secondary objectives include 1) determining feasibility of the intervention (as measured by the percentage of prescribed days of exercise completed by each participant, and percentage of time exercising completed at the prescribed intensity and duration); 2) determining the influence of exercise training on aerobic fitness and strength in the sample; and 3) determining whether psychiatric/somatic symptom improvements are associated with improvements in fitness and strength. Finally, exploratory objectives will include examining whether exercise training can improve early signs of heart disease, and whether certain biomarkers (using MRI and fMRI data and inflammatory markers) are associated with treatment response.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-65yr
- •Diagnosis of PTSD
- •Reported combat exposure per the Deployment Risk and Resilience Inventory (DRRI)
- •Sedentary lifestyle (planned activity for purpose of health < 2 days/wk)
- •Capability of giving informed consent
排除标准
- •Abuse of alcohol or drugs
- •Homelessness
- •Significant cognitive impairment (e.g., MMSE score of ≤ 26) that would hinder ability to understand the protocol
- •Signs or symptoms of cardiovascular, metabolic or pulmonary disease that would preclude participating in the exercise, including uncontrolled hypertension (> 159/99 mm Hg)
- •Usage of beta blockers, which could influence the heart rate response to exercise
- •Any physical or mental health condition that would contraindicate participation in the study (e.g., musculoskeletal, orthopedic, and/or neuromuscular disorders)
- •High suicidality
- •Below cutoff on either STAI (<30) or PCL-M (<40)
- •Pregnancy or plans to become pregnant in the next 4 months
- •Excessive levels of physical activity assessed via interview and pedometer recording
- •Current treatment for PTSD (drug or counseling) for a duration of less than eight weeks
- •Clinically judged to be unsuitable for participation by the research physician
结局指标
主要结局
Efficacy as measured by a reduction in symptoms of posttraumatic stress disorder.
时间窗: from pre- to post-treatment during 8-week intervention.
Efficacy will be determined by a reduction in posttraumatic stress disorder symptoms as measured by the Clinician-Administered PTSD Scale-2 (CAPS-2).
次要结局
- Feasibility as measured by adherence to the intervention.(during the 8-week intervention)
- Efficacy as measured by improvements in strength and fitness.(from pre- to post-treatment during 8-week intervention.)