Exploring the Effects of Exercise Training on PTSD Symptoms and Physical Health in Older Veterans With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Clinician-Administered PTSD Scale for DSM-V (CAPS-5)
研究概览
简要总结
Posttraumatic stress disorder (PTSD) is prevalent among military Veterans and is more than just a psychological condition; PTSD has profound negative impacts on health, function, and quality of life. Older Veterans are the largest patient population served by the Veterans Health Administration (VHA), and many have lived with PTSD for 40+ years. Veterans with PTSD engage in low levels of physical activity and spend much of their time in sedentary activities, adding to their risk of physical disability. The benefits of exercise on mental health and physical well-being in older adults are well-substantiated, but the effects of exercise training on late-life PTSD symptoms is a new area of study. This study is designed to examine the effects of 6 months of supervised exercise training on PTSD symptoms and PTSD-related conditions (e.g., functional impairment, sleep) in 188 older Veterans with PTSD.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran status
- •registered for care at Durham VA Health Care System (VAHCS)
- •live within 50 miles of fitness facility
- •meet diagnostic criteria for PTSD as assessed by the CAPS-5
排除标准
- •history of any psychiatric disorder with severe psychotic features in the past 5 years (e.g., bipolar disorder, mania), as indicated by ICD-10 codes F20-F29 (ICD-9 category 298.9)
- •prominent suicidal ideation or hospitalization for suicidality in the previous 6 months
- •clinically significant: neurological disorder, systemic illness affecting central nervous system (CNS) function, or history of seizure disorder in the past 5 years
- •uncontrolled diabetes defined as:
- •Abnormal fasting plasma glucose 126 mg/dL, random plasma glucose 200 mg/dL
- •no active medications for diabetes management (Metformin, insulin, etc.)
- •no clinical notes in the patient's electronic health record (EHR) indicating monitoring by primary care physician (PCP) or Endo for diabetes management)
- •end stage liver disease or currently receiving dialysis
- •physical disabilities precluding use of exercise equipment (assistive mobility devices acceptable)
- •significant cognitive impairment or diagnosis of Alzheimer's Disease or Dementia
- •hospitalization or ER visit in the past 6 months for conditions contraindicated for exercise (cardiac event; physical trauma)
结局指标
主要结局
Clinician-Administered PTSD Scale for DSM-V (CAPS-5)
时间窗: 6 months
PTSD symptoms over the previous month will be assessed with the CAPS-5 clinical interview. Total symptom severity score and symptom cluster severity scores will be calculated. Scores range from 0 to 80, with higher scores reflecting more sever PTSD symptoms.
Six-minute walk test
时间窗: 6 months
Performance-based measure of aerobic endurance. Participants are instructed to walk along a measured course for 6 minutes. The distance walked in 6 minutes (feet) is the outcome of this assessment. There is no maximum value for this test, but the minimum value could be 0 (unable to walk any distance).
次要结局
- Patient Health Questionnaire (PHQ-9)(6 months)
- Pittsburgh Sleep Quality Index (PSQI)(6 months)