Feasibility of a Yoga Program for Veterans With PTSD

NCT05177757 | Completed

• 1 other identifier: HR- 3973
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (19)

• Endocannabinoid assay

  Endocannabinoid ligands reported in ng/ml

  Change in ligands from baseline to12 weeks

• Cortisol assay

  Cortisol reported in μg/dL

  Change in cortisol from baseline to12 weeks

• Cognitive functioning using a computerized battery

  Performance on cognitive tasks reported in accuracy and reaction time

  Change in performance from baseline to12 weeks

• Body Mass Index (BMI)

  Body Mass Index (BMI) calculated by height and weight

  Change in BMI from baseline to12 weeks

• Blood pressure

  Blood pressure reported in systolic and diastolic (mmHg)

  Change in blood pressure from baseline to12 weeks

• Heart rate

  Heart rate reported in beats per minute (BPM)

  Change in heart rate from baseline to12 weeks

• Heart rate variability (HRV)

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

  Change in HRV from baseline to12 weeks

• Lung functioning

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

  Change in lung functioning from baseline to12 weeks

• Range of motion

  Range of motion measured by goniometer reported in degrees

  Change in range of motion from baseline to12 weeks

• Body composition

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

  Change in body composition from baseline to12 weeks

• Hand grip strength

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

  Change in hand grip strength from baseline to12 weeks

• Aerobic fitness

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

  Change in aerobic fitness from baseline to12 weeks

• Physical activity

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

  Change in physical activity from baseline to12 weeks

• Severity of posttraumatic stress disorder (PTSD)

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

  Change in scores from baseline to12 weeks

• Frequency of physical activity

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

  Change in scores from baseline to12 weeks

• Physical health rating

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

  Change in scores from baseline to12 weeks

• Severity of sleep disturbance

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

  Change in scores from baseline to12 weeks

• Mindfulness rating

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

  Change in scores from baseline to12 weeks

• Frequency of yoga rating

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

  Change in scores from baseline to12 weeks

Study Arms (1)

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.

Other: Yoga Intervention

Interventions

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.

Yoga Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• U.S. Military Veteran
• 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+)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Marquette University: lead

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53207, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jacklynn Fitzgerald, PhD

  Marquette University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: January 5, 2022
• Study Start: January 3, 2022
• Primary Completion: May 27, 2022
• Study Completion: May 28, 2022
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)