Feasibility of a Yoga Program for Veterans With PTSD
2 de septiembre de 2022 actualizado por: Jacklynn Fitzgerald, Marquette University
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
14
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53207
- Marquette University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Endocannabinoid assay
Periodo de tiempo: Change in ligands from baseline to12 weeks
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Endocannabinoid ligands reported in ng/ml
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Change in ligands from baseline to12 weeks
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Cortisol assay
Periodo de tiempo: Change in cortisol from baseline to12 weeks
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Cortisol reported in μg/dL
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Change in cortisol from baseline to12 weeks
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Cognitive functioning using a computerized battery
Periodo de tiempo: Change in performance from baseline to12 weeks
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Performance on cognitive tasks reported in accuracy and reaction time
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Change in performance from baseline to12 weeks
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Body Mass Index (BMI)
Periodo de tiempo: Change in BMI from baseline to12 weeks
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Body Mass Index (BMI) calculated by height and weight
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Change in BMI from baseline to12 weeks
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Blood pressure
Periodo de tiempo: Change in blood pressure from baseline to12 weeks
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Blood pressure reported in systolic and diastolic (mmHg)
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Change in blood pressure from baseline to12 weeks
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Heart rate
Periodo de tiempo: Change in heart rate from baseline to12 weeks
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Heart rate reported in beats per minute (BPM)
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Change in heart rate from baseline to12 weeks
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Heart rate variability (HRV)
Periodo de tiempo: Change in HRV from baseline to12 weeks
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Heart rate variability (HRV) reported in the standard deviation of the RR intervals (distance between heartbeats) as quantified on standard electrocardiogram (ECG)
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Change in HRV from baseline to12 weeks
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Lung functioning
Periodo de tiempo: Change in lung functioning from baseline to12 weeks
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Lung functioning measured by spirometry reported in vital capacity (VC)
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Change in lung functioning from baseline to12 weeks
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Range of motion
Periodo de tiempo: Change in range of motion from baseline to12 weeks
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Range of motion measured by goniometer reported in degrees
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Change in range of motion from baseline to12 weeks
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Body composition
Periodo de tiempo: Change in body composition from baseline to12 weeks
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Body composition measured by dual-energy x-ray absorptiometry (DEXA) reported in volume cubic meters (m3) and mass (kilograms)
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Change in body composition from baseline to12 weeks
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Hand grip strength
Periodo de tiempo: Change in hand grip strength from baseline to12 weeks
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Hand grip strength measured by a dynamometer reported in pounds (lbs)
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Change in hand grip strength from baseline to12 weeks
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Aerobic fitness
Periodo de tiempo: Change in aerobic fitness from baseline to12 weeks
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Aerobic fitness measured by a submaximal graded exercise test reported in the volume of oxygen consumed (VO2)
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Change in aerobic fitness from baseline to12 weeks
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Physical activity
Periodo de tiempo: Change in physical activity from baseline to12 weeks
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Physical activity measured by a accelerometer reported in change in velocity over time (meters per seconds)
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Change in physical activity from baseline to12 weeks
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Severity of posttraumatic stress disorder (PTSD)
Periodo de tiempo: Change in scores from baseline to12 weeks
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Scores on the Clinician Administered PTSD Scale (CAPS-5) (range 0-80; higher scores indicate more severity)
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Change in scores from baseline to12 weeks
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Frequency of physical activity
Periodo de tiempo: Change in scores from baseline to12 weeks
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Scores on the International Physical Activity Questionnaire-Short Form (IPAQ-SF) reported in hours and minutes each day
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Change in scores from baseline to12 weeks
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Physical health rating
Periodo de tiempo: Change in scores from baseline to12 weeks
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Scores on the Medical Outcomes Study-Short Form (SF-36) (range 0-100; higher scores indicate better health outcome)
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Change in scores from baseline to12 weeks
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Severity of sleep disturbance
Periodo de tiempo: Change in scores from baseline to12 weeks
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Scores on the Pittsburgh Sleep Quality Index (PSQI) (range 0-21; higher scores indicate worse sleep quality)
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Change in scores from baseline to12 weeks
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Mindfulness rating
Periodo de tiempo: Change in scores from baseline to12 weeks
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Scores on the Five Facet Mindfulness Questionnaire (FFMQ) (range 39-195; higher scores indicate more mindfulness)
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Change in scores from baseline to12 weeks
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Frequency of yoga rating
Periodo de tiempo: Change in scores from baseline to12 weeks
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Scores on the Yoga and Self-efficacy Scale (YSES) (range 12-108; higher scores indicate more engagement with yoga practices)
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Change in scores from baseline to12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jacklynn Fitzgerald, PhD, Marquette University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de enero de 2022
Finalización primaria (Actual)
27 de mayo de 2022
Finalización del estudio (Actual)
28 de mayo de 2022
Fechas de registro del estudio
Enviado por primera vez
10 de noviembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
3 de enero de 2022
Publicado por primera vez (Actual)
5 de enero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de septiembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
2 de septiembre de 2022
Última verificación
1 de septiembre de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HR- 3973
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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