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Completed

NCT Number: NCT05177757

Feasibility of a Yoga Program for Veterans With PTSD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marquette University

Milwaukee, Wisconsin, 53207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Yoga Intervention

Other

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 outcomes

  1. Endocannabinoid assay

    Time frame: Change in ligands from baseline to12 weeks

    Endocannabinoid ligands reported in ng/ml

  2. Cortisol assay

    Time frame: Change in cortisol from baseline to12 weeks

    Cortisol reported in μg/dL

  3. Cognitive functioning using a computerized battery

    Time frame: Change in performance from baseline to12 weeks

    Performance on cognitive tasks reported in accuracy and reaction time

  4. Body Mass Index (BMI)

    Time frame: Change in BMI from baseline to12 weeks

    Body Mass Index (BMI) calculated by height and weight

  5. Blood pressure

    Time frame: Change in blood pressure from baseline to12 weeks

    Blood pressure reported in systolic and diastolic (mmHg)

  6. Heart rate

    Time frame: Change in heart rate from baseline to12 weeks

    Heart rate reported in beats per minute (BPM)

  7. Heart rate variability (HRV)

    Time frame: 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)

  8. Lung functioning

    Time frame: Change in lung functioning from baseline to12 weeks

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

  9. Range of motion

    Time frame: Change in range of motion from baseline to12 weeks

    Range of motion measured by goniometer reported in degrees

  10. Body composition

    Time frame: 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)

  11. Hand grip strength

    Time frame: Change in hand grip strength from baseline to12 weeks

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

  12. Aerobic fitness

    Time frame: 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)

  13. Physical activity

    Time frame: Change in physical activity from baseline to12 weeks

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

  14. Severity of posttraumatic stress disorder (PTSD)

    Time frame: Change in scores from baseline to12 weeks

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

  15. Frequency of physical activity

    Time frame: 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

  16. Physical health rating

    Time frame: 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)

  17. Severity of sleep disturbance

    Time frame: Change in scores from baseline to12 weeks

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

  18. Mindfulness rating

    Time frame: Change in scores from baseline to12 weeks

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

  19. Frequency of yoga rating

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Marquette University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2022
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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