Feasibility of a Yoga Program for Veterans With PTSD

Sponsor
Marquette University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05177757
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Yoga Intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility of a Yoga Program for Veterans With PTSD
Actual Study Start Date :
Feb 16, 2022
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Endocannabinoid assay [Change in ligands from baseline to12 weeks]

    Endocannabinoid ligands reported in ng/ml

  2. Cortisol assay [Change in cortisol from baseline to12 weeks]

    Cortisol reported in μg/dL

  3. Cognitive functioning using a computerized battery [Change in performance from baseline to12 weeks]

    Performance on cognitive tasks reported in accuracy and reaction time

  4. Body Mass Index (BMI) [Change in BMI from baseline to12 weeks]

    Body Mass Index (BMI) calculated by height and weight

  5. Blood pressure [Change in blood pressure from baseline to12 weeks]

    Blood pressure reported in systolic and diastolic (mmHg)

  6. Heart rate [Change in heart rate from baseline to12 weeks]

    Heart rate reported in beats per minute (BPM)

  7. 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)

  8. Lung functioning [Change in lung functioning from baseline to12 weeks]

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

  9. Range of motion [Change in range of motion from baseline to12 weeks]

    Range of motion measured by goniometer reported in degrees

  10. 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)

  11. Hand grip strength [Change in hand grip strength from baseline to12 weeks]

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

  12. 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)

  13. 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)

  14. 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)

  15. 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

  16. 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)

  17. 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)

  18. 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)

  19. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marquette University Milwaukee Wisconsin United States 53207

Sponsors and Collaborators

  • Marquette University

Investigators

  • Principal Investigator: Jacklynn Fitzgerald, PhD, Marquette University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jacklynn Fitzgerald, Assistant Professor, Marquette University
ClinicalTrials.gov Identifier:
NCT05177757
Other Study ID Numbers:
  • HR- 3973
First Posted:
Jan 5, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022