Feasibility of a Yoga Program for Veterans With PTSD

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Yoga Intervention

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Marquette University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Endocannabinoid assay

Endocannabinoid ligands reported in ng/ml

Cortisol assay

Cortisol reported in μg/dL

Cognitive functioning using a computerized battery

Performance on cognitive tasks reported in accuracy and reaction time

Body Mass Index (BMI)

Body Mass Index (BMI) calculated by height and weight

Blood pressure

Blood pressure reported in systolic and diastolic (mmHg)

Heart rate

Heart rate reported in beats per minute (BPM)

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)

Lung functioning

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

Range of motion

Range of motion measured by goniometer reported in degrees

Body composition

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

Hand grip strength

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

Aerobic fitness

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

Physical activity

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

Severity of posttraumatic stress disorder (PTSD)

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

Frequency of physical activity

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

Physical health rating

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

Severity of sleep disturbance

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

Mindfulness rating

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

Frequency of yoga rating

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05177757

First Posted

November 10, 2021

Last Updated

September 2, 2022

Sponsor

Marquette University

1. Study Identification

Unique Protocol Identification Number

NCT05177757

Brief Title

Feasibility of a Yoga Program for Veterans With PTSD

Official Title

Feasibility of a Yoga Program for Veterans With PTSD

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

January 3, 2022 (Actual)

Primary Completion Date

May 27, 2022 (Actual)

Study Completion Date

May 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Marquette University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Disorders, Post-Traumatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Yoga Intervention

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Yoga Intervention

Intervention Description

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 Measure Information:

Title

Endocannabinoid assay

Description

Endocannabinoid ligands reported in ng/ml

Time Frame

Change in ligands from baseline to12 weeks

Title

Cortisol assay

Description

Cortisol reported in μg/dL

Time Frame

Change in cortisol from baseline to12 weeks

Title

Cognitive functioning using a computerized battery

Description

Performance on cognitive tasks reported in accuracy and reaction time

Time Frame

Change in performance from baseline to12 weeks

Title

Body Mass Index (BMI)

Description

Body Mass Index (BMI) calculated by height and weight

Time Frame

Change in BMI from baseline to12 weeks

Title

Blood pressure

Description

Blood pressure reported in systolic and diastolic (mmHg)

Time Frame

Change in blood pressure from baseline to12 weeks

Title

Heart rate

Description

Heart rate reported in beats per minute (BPM)

Time Frame

Change in heart rate from baseline to12 weeks

Title

Heart rate variability (HRV)

Description

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

Time Frame

Change in HRV from baseline to12 weeks

Title

Lung functioning

Description

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

Time Frame

Change in lung functioning from baseline to12 weeks

Title

Range of motion

Description

Range of motion measured by goniometer reported in degrees

Time Frame

Change in range of motion from baseline to12 weeks

Title

Body composition

Description

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

Time Frame

Change in body composition from baseline to12 weeks

Title

Hand grip strength

Description

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

Time Frame

Change in hand grip strength from baseline to12 weeks

Title

Aerobic fitness

Description

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

Time Frame

Change in aerobic fitness from baseline to12 weeks

Title

Physical activity

Description

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

Time Frame

Change in physical activity from baseline to12 weeks

Title

Severity of posttraumatic stress disorder (PTSD)

Description

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

Time Frame