Effects of an Interdisciplinary Fitness and Social Engagement Intervention (InFuSe)
2018年8月31日 更新者：Washington D.C. Veterans Affairs Medical Center
Effects of an Interdisciplinary Fitness and Social Engagement Intervention on Physical Activity, Sleep Quality and Community Integration
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
24
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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District of Columbia
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Washington、District of Columbia、美国、20422
- Washington DC VA Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：InFuSE
Experimental group which will receive health education, group discussion, and supervised exercise.
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Each session includes a 45-minute education and group discussion.
A 60-minute exercise component then completes the session.
Each topic was specifically picked and tailored to benefit Veterans with TBI.
The education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians.
Participants will be asked to participate in several learning activities.
The activities are included to help improve understanding and promote group discussion.
The exercise piece consists of a warm-up, endurance training (20-30 minutes), strengthening (15 minutes), balance/cognitive training (15 minutes), and a cool-down.
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有源比较器：Patient Education/Group Discussion
Active control group which will receive health education and group discussion.
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Each week you will participate in a 1 hour health education class with other Veterans.
Each topic was specifically picked and tailored for Veterans with TBI.
These education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians.
Participants will be asked to participate in several learning activities which are included to help improve understanding and promote group discussion.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Exercise Self-Efficacy Scale (ESES)
大体时间：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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ESES measures an individual's perceived ability to overcome various obstacles to perform physical activity.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Sleep Efficiency
大体时间：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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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.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional Capacity
大体时间：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Functional capacity is evaluated using a Bruce protocol treadmill maximal exertion stress test.
The maximum amount of work performed by the participant on the treadmill is measured as metabolic equivalents (METs)
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Dynamic Gait Index (DGI)
大体时间：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Pittsburgh Sleep Quality Index (PSQI)
大体时间：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-reported measure to evaluate and monitor overall sleep quality.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Mayo Portland Adaptability Index (MPAI-4)
大体时间：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A measure of self-reported quality of life, limitation severity, and community participation after TBI.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Community Reintegration of Service Members (CRIS)
大体时间：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-reported measure of the ability of service members to reintegrate after returning to civilian life.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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California Verbal Learning Test-Second Edition (CVLT-II)
大体时间：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A widely used measure of verbal learning and memory using a multiple-trial list-learning task.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Brief Symptoms Inventory 18 (BSI-18)
大体时间：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A self-report measure of depression, anxiety, somatic concerns, and general distress.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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Post-Traumatic Stress Disorder Checklist (PCL)
大体时间：Change from baseline, after intervention (week 11), and 3 months after (week 24)
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A measure of the severity of PTSD related symptoms including intrusive thoughts, avoidance behavior, and arousal.
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Change from baseline, after intervention (week 11), and 3 months after (week 24)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年6月1日
初级完成 (预期的)
2018年12月1日
研究完成 (预期的)
2018年12月1日
研究注册日期
首次提交
2017年3月28日
首先提交符合 QC 标准的
2017年5月17日
首次发布 (实际的)
2017年5月19日
研究记录更新
最后更新发布 (实际的)
2018年9月4日
上次提交的符合 QC 标准的更新
2018年8月31日
最后验证
2018年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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