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Clinical Trials/NCT05177757
NCT05177757
Completed
Not Applicable

Feasibility of a Yoga Program for Veterans With PTSD

Marquette University1 site in 1 country14 target enrollmentJanuary 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Disorders, Post-Traumatic
Sponsor
Marquette University
Enrollment
14
Locations
1
Primary Endpoint
Cortisol assay
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2022
End Date
May 28, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jacklynn Fitzgerald

Assistant Professor

Marquette University

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Cortisol assay

Time Frame: Change in cortisol from baseline to12 weeks

Cortisol reported in μg/dL

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

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

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)

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)

Endocannabinoid assay

Time Frame: Change in ligands from baseline to12 weeks

Endocannabinoid ligands reported in ng/ml

Body Mass Index (BMI)

Time Frame: Change in BMI from baseline to12 weeks

Body Mass Index (BMI) calculated by height and weight

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)

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)

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)

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)

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)

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)

Blood pressure

Time Frame: Change in blood pressure from baseline to12 weeks

Blood pressure reported in systolic and diastolic (mmHg)

Range of motion

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

Range of motion measured by goniometer reported in degrees

Lung functioning

Time Frame: Change in lung functioning from baseline to12 weeks

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

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)

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)

Heart rate

Time Frame: Change in heart rate from baseline to12 weeks

Heart rate reported in beats per minute (BPM)

Study Sites (1)

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