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临床试验/NCT05177757
NCT05177757已完成不适用

Feasibility of a Yoga Program for Veterans With PTSD

Marquette University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年1月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Cortisol assay

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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+)

排除标准

  • •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)

研究组 & 干预措施

Yoga Intervention

Experimental

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.

干预措施: Yoga Intervention (Other)

结局指标

主要结局

Cortisol assay

时间窗: Change in cortisol from baseline to12 weeks

Cortisol reported in μg/dL

Cognitive functioning using a computerized battery

时间窗: Change in performance from baseline to12 weeks

Performance on cognitive tasks reported in accuracy and reaction time

Frequency of physical activity

时间窗: Change in scores from baseline to12 weeks

Scores on the International Physical Activity Questionnaire-Short Form (IPAQ-SF) reported in hours and minutes each day

Severity of sleep disturbance

时间窗: Change in scores from baseline to12 weeks

Scores on the Pittsburgh Sleep Quality Index (PSQI) (range 0-21; higher scores indicate worse sleep quality)

Frequency of yoga rating

时间窗: Change in scores from baseline to12 weeks

Scores on the Yoga and Self-efficacy Scale (YSES) (range 12-108; higher scores indicate more engagement with yoga practices)

Endocannabinoid assay

时间窗: Change in ligands from baseline to12 weeks

Endocannabinoid ligands reported in ng/ml

Body Mass Index (BMI)

时间窗: Change in BMI from baseline to12 weeks

Body Mass Index (BMI) calculated by height and weight

Heart rate variability (HRV)

时间窗: Change in HRV from baseline to12 weeks

Heart rate variability (HRV) reported in the standard deviation of the RR intervals (distance between heartbeats) as quantified on standard electrocardiogram (ECG)

Hand grip strength

时间窗: Change in hand grip strength from baseline to12 weeks

Hand grip strength measured by a dynamometer reported in pounds (lbs)

Physical activity

时间窗: Change in physical activity from baseline to12 weeks

Physical activity measured by a accelerometer reported in change in velocity over time (meters per seconds)

Severity of posttraumatic stress disorder (PTSD)

时间窗: Change in scores from baseline to12 weeks

Scores on the Clinician Administered PTSD Scale (CAPS-5) (range 0-80; higher scores indicate more severity)

Physical health rating

时间窗: Change in scores from baseline to12 weeks

Scores on the Medical Outcomes Study-Short Form (SF-36) (range 0-100; higher scores indicate better health outcome)

Mindfulness rating

时间窗: Change in scores from baseline to12 weeks

Scores on the Five Facet Mindfulness Questionnaire (FFMQ) (range 39-195; higher scores indicate more mindfulness)

Blood pressure

时间窗: Change in blood pressure from baseline to12 weeks

Blood pressure reported in systolic and diastolic (mmHg)

Range of motion

时间窗: Change in range of motion from baseline to12 weeks

Range of motion measured by goniometer reported in degrees

Heart rate

时间窗: Change in heart rate from baseline to12 weeks

Heart rate reported in beats per minute (BPM)

Lung functioning

时间窗: Change in lung functioning from baseline to12 weeks

Lung functioning measured by spirometry reported in vital capacity (VC)

Body composition

时间窗: Change in body composition from baseline to12 weeks

Body composition measured by dual-energy x-ray absorptiometry (DEXA) reported in volume cubic meters (m3) and mass (kilograms)

Aerobic fitness

时间窗: Change in aerobic fitness from baseline to12 weeks

Aerobic fitness measured by a submaximal graded exercise test reported in the volume of oxygen consumed (VO2)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacklynn Fitzgerald

Assistant Professor

Marquette University

研究点 (1)

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