Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Exercise Self-Efficacy Scale (ESES)
研究概览
简要总结
This study will evaluate feasibility and preliminary effectiveness of a 10-week interdisciplinary and multimodal intervention that utilizes patient education, group discussion, and supervised exercise for Veterans with a history of traumatic brain injury (TBI). Primary outcomes include physical activity (PA), sleep quality, and community integration.
详细描述
This randomized controlled trial will have a sample size of 24. Veterans between the ages of 18 and 65 in the Polytrauma and TBI program who are greater than 1 year post injury prior to entering the study, will be recruited. After randomization participants in the intervention group will complete a 10 week bout of multidisciplinary wellness education, group discussion, and supervised exercise. The intervention will occur weekly and last up to 2 hours. The control group will complete a 10week comprehensive health education program simultaneously. All measures will be collected again, post intervention. A follow-up collection will occur at 3 months post-intervention.
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 (Outcomes Assessor)
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
- •TBI of at least mild severity using criteria related to disturbance of consciousness
- •Most recent TBI occurred >1 year prior to consent process
- •Medically stable with physician approval to participate
排除标准
- •Unable to provide informed consent and no proxy available
- •Prior history of known bipolar disorder or schizophrenia or severe psychiatric illness
- •Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension)
- •Veteran is currently active in a skilled physical therapy program.
- •Veterans who meet or exceed American Heart Association and American College of Sports Medicine guidelines for physical activity
结局指标
主要结局
Exercise Self-Efficacy Scale (ESES)
时间窗: Change from baseline, after intervention (week 11), and 3 months after (week 24)
ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity.
Sleep Efficiency
时间窗: Change from baseline, after intervention (week 11), and 3 months after (week 24)
Sleep efficiency is the total number of minutes of sleep divided by the number of minutes spent in bed. Sleep efficiency is measured by polysomnography.
次要结局
- Dynamic Gait Index (DGI)(Change from baseline, after intervention (week 11), and 3 months after (week 24))
- Community Reintegration of Service Members (CRIS)(Change from baseline, after intervention (week 11), and 3 months after (week 24))
- Pittsburgh Sleep Quality Index (PSQI)(Change from baseline, after intervention (week 11), and 3 months after (week 24))
- Mayo Portland Adaptability Index (MPAI-4)(Change from baseline, after intervention (week 11), and 3 months after (week 24))
- Functional Capacity(Change from baseline, after intervention (week 11), and 3 months after (week 24))