Feasibility of a Yoga Program for Veterans With PTSD

Not Applicable

Completed

• Conditions: Stress Disorders, Post-Traumatic
• Interventions: Other: Yoga Intervention

• Registration Number: NCT05177757
• Lead Sponsor: Marquette University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-10
• Study Start: 2022-01-03
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-05
• Primary Completion: 2022-05-27
• Study Completion: 2022-05-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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+)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yoga Intervention	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.

Primary Outcome Measures

Name	Time	Method
Cortisol assay	Change in cortisol from baseline to12 weeks	Cortisol reported in μg/dL
Cognitive functioning using a computerized battery	Change in performance from baseline to12 weeks	Performance on cognitive tasks reported in accuracy and reaction time
Frequency of physical activity	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	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	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	Change in ligands from baseline to12 weeks	Endocannabinoid ligands reported in ng/ml
Body Mass Index (BMI)	Change in BMI from baseline to12 weeks	Body Mass Index (BMI) calculated by height and weight
Heart rate variability (HRV)	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	Change in hand grip strength from baseline to12 weeks	Hand grip strength measured by a dynamometer reported in pounds (lbs)
Physical activity	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)	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	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	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	Change in blood pressure from baseline to12 weeks	Blood pressure reported in systolic and diastolic (mmHg)
Range of motion	Change in range of motion from baseline to12 weeks	Range of motion measured by goniometer reported in degrees
Heart rate	Change in heart rate from baseline to12 weeks	Heart rate reported in beats per minute (BPM)
Lung functioning	Change in lung functioning from baseline to12 weeks	Lung functioning measured by spirometry reported in vital capacity (VC)
Body composition	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	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)

Trial Locations

Locations (1)

Marquette University; 🇺🇸 Milwaukee, Wisconsin, United States