Feasibility of a Yoga Program for Veterans With PTSD
2. september 2022 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
14
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53207
- Marquette University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Endocannabinoid assay
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Jacklynn Fitzgerald, PhD, Marquette University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. januar 2022
Primær fullføring (Faktiske)
27. mai 2022
Studiet fullført (Faktiske)
28. mai 2022
Datoer for studieregistrering
Først innsendt
10. november 2021
Først innsendt som oppfylte QC-kriteriene
3. januar 2022
Først lagt ut (Faktiske)
5. januar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. september 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. september 2022
Sist bekreftet
1. september 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HR- 3973
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