Feasibility of a Yoga Program for Veterans With PTSD
2022年9月2日 更新者:Jacklynn Fitzgerald、Marquette University
This study is designed to examine the feasibility of a 12-week yoga program on physiological and psychological health and its neurobiological mechanisms in N=15 veterans with posttraumatic stress disorder (PTSD).
The investigators will be examining specific parameters of health and mechanisms before and after the yoga program.
研究概览
研究类型
介入性
注册 (实际的)
14
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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Wisconsin
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Milwaukee、Wisconsin、美国、53207
- Marquette University
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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 及以上 (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:
- U.S. Military Veteran
- 18 years of age or older
- Diagnosis of PTSD as assessed by a score of >30 on the PTSD-Checklist Version 5 (PCL-5)
- Willing and able to attend testing and yoga sessions at the Athletic and Human Research Performance Center (AHPRC) on the campus of Marquette University
- Clear to participate in physical activity based on the Physical Activity Readiness Questionnaire (PARQ+)
Exclusion Criteria:
- Currently pregnant or trying to become pregnant
- Positive score to one or more items on the PAR-Q+ without physician approval
- Already established regular use of yoga (i.e., more than one day per week)
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:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Yoga Intervention
The yoga exercise program will be conducted at the Marquette campus and will consist of one session per week for 12 weeks.
The duration of each session will be approximately one hour.
The program the investigators will use is the Mindful Resilience for Trauma Recovery Program (https://www.veteransyogaproject.org/), an evidence-informed practice adapted for veterans with PTSD based on clinical and neuroscientific knowledge.
This program is a 12-week protocol developed by a licensed clinical psychologist and is publicly available.
All yoga sessions will be standardized based on the resilience program guidelines.
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The yoga exercise program will be conducted at the Marquette campus and will consist of one session per week for 12 weeks.
The duration of each session will be approximately one hour.
The program the investigators will use is the Mindful Resilience for Trauma Recovery Program (https://www.veteransyogaproject.org/), an evidence-informed practice adapted for veterans with PTSD based on clinical and neuroscientific knowledge.
This program is a 12-week protocol developed by a licensed clinical psychologist and is publicly available.
All yoga sessions will be standardized based on the resilience program guidelines.
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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 |
---|---|---|
Endocannabinoid assay
大体时间:Change in ligands from baseline to12 weeks
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Endocannabinoid ligands reported in ng/ml
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Change in ligands from baseline to12 weeks
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Cortisol assay
大体时间:Change in cortisol from baseline to12 weeks
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Cortisol reported in μg/dL
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Change in cortisol from baseline to12 weeks
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Cognitive functioning using a computerized battery
大体时间:Change in performance from baseline to12 weeks
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Performance on cognitive tasks reported in accuracy and reaction time
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Change in performance from baseline to12 weeks
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Body Mass Index (BMI)
大体时间:Change in BMI from baseline to12 weeks
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Body Mass Index (BMI) calculated by height and weight
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Change in BMI from baseline to12 weeks
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Blood pressure
大体时间:Change in blood pressure from baseline to12 weeks
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Blood pressure reported in systolic and diastolic (mmHg)
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Change in blood pressure from baseline to12 weeks
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Heart rate
大体时间:Change in heart rate from baseline to12 weeks
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Heart rate reported in beats per minute (BPM)
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Change in heart rate from baseline to12 weeks
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Heart rate variability (HRV)
大体时间:Change in HRV from baseline to12 weeks
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Heart rate variability (HRV) reported in the standard deviation of the RR intervals (distance between heartbeats) as quantified on standard electrocardiogram (ECG)
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Change in HRV from baseline to12 weeks
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Lung functioning
大体时间:Change in lung functioning from baseline to12 weeks
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Lung functioning measured by spirometry reported in vital capacity (VC)
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Change in lung functioning from baseline to12 weeks
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Range of motion
大体时间:Change in range of motion from baseline to12 weeks
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Range of motion measured by goniometer reported in degrees
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Change in range of motion from baseline to12 weeks
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Body composition
大体时间:Change in body composition from baseline to12 weeks
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Body composition measured by dual-energy x-ray absorptiometry (DEXA) reported in volume cubic meters (m3) and mass (kilograms)
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Change in body composition from baseline to12 weeks
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Hand grip strength
大体时间:Change in hand grip strength from baseline to12 weeks
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Hand grip strength measured by a dynamometer reported in pounds (lbs)
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Change in hand grip strength from baseline to12 weeks
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Aerobic fitness
大体时间:Change in aerobic fitness from baseline to12 weeks
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Aerobic fitness measured by a submaximal graded exercise test reported in the volume of oxygen consumed (VO2)
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Change in aerobic fitness from baseline to12 weeks
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Physical activity
大体时间:Change in physical activity from baseline to12 weeks
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Physical activity measured by a accelerometer reported in change in velocity over time (meters per seconds)
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Change in physical activity from baseline to12 weeks
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Severity of posttraumatic stress disorder (PTSD)
大体时间:Change in scores from baseline to12 weeks
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Scores on the Clinician Administered PTSD Scale (CAPS-5) (range 0-80; higher scores indicate more severity)
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Change in scores from baseline to12 weeks
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Frequency of physical activity
大体时间:Change in scores from baseline to12 weeks
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Scores on the International Physical Activity Questionnaire-Short Form (IPAQ-SF) reported in hours and minutes each day
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Change in scores from baseline to12 weeks
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Physical health rating
大体时间:Change in scores from baseline to12 weeks
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Scores on the Medical Outcomes Study-Short Form (SF-36) (range 0-100; higher scores indicate better health outcome)
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Change in scores from baseline to12 weeks
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Severity of sleep disturbance
大体时间:Change in scores from baseline to12 weeks
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Scores on the Pittsburgh Sleep Quality Index (PSQI) (range 0-21; higher scores indicate worse sleep quality)
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Change in scores from baseline to12 weeks
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Mindfulness rating
大体时间:Change in scores from baseline to12 weeks
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Scores on the Five Facet Mindfulness Questionnaire (FFMQ) (range 39-195; higher scores indicate more mindfulness)
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Change in scores from baseline to12 weeks
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Frequency of yoga rating
大体时间:Change in scores from baseline to12 weeks
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Scores on the Yoga and Self-efficacy Scale (YSES) (range 12-108; higher scores indicate more engagement with yoga practices)
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Change in scores from baseline to12 weeks
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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。
调查人员
- 首席研究员:Jacklynn Fitzgerald, PhD、Marquette University
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)
2022年1月3日
初级完成 (实际的)
2022年5月27日
研究完成 (实际的)
2022年5月28日
研究注册日期
首次提交
2021年11月10日
首先提交符合 QC 标准的
2022年1月3日
首次发布 (实际的)
2022年1月5日
研究记录更新
最后更新发布 (实际的)
2022年9月6日
上次提交的符合 QC 标准的更新
2022年9月2日
最后验证
2022年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- HR- 3973
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Yoga Intervention的临床试验
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Florida Atlantic UniversityNational Center for Complementary and Integrative Health (NCCIH)完全的
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Oslo University HospitalAkershus University Hospital, Lørenskog, Norway; Koc University Hospital, Istanbul, Turkey; Ataturk... 和其他合作者完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人