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Feasibility of a Yoga Program for Veterans With PTSD

2 september 2022 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

14

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Wisconsin
      • Milwaukee, Wisconsin, Förenta staterna, 53207
        • Marquette University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Endocannabinoid assay
Tidsram: Change in ligands from baseline to12 weeks
Endocannabinoid ligands reported in ng/ml
Change in ligands from baseline to12 weeks
Cortisol assay
Tidsram: Change in cortisol from baseline to12 weeks
Cortisol reported in μg/dL
Change in cortisol from baseline to12 weeks
Cognitive functioning using a computerized battery
Tidsram: Change in performance from baseline to12 weeks
Performance on cognitive tasks reported in accuracy and reaction time
Change in performance from baseline to12 weeks
Body Mass Index (BMI)
Tidsram: Change in BMI from baseline to12 weeks
Body Mass Index (BMI) calculated by height and weight
Change in BMI from baseline to12 weeks
Blood pressure
Tidsram: Change in blood pressure from baseline to12 weeks
Blood pressure reported in systolic and diastolic (mmHg)
Change in blood pressure from baseline to12 weeks
Heart rate
Tidsram: Change in heart rate from baseline to12 weeks
Heart rate reported in beats per minute (BPM)
Change in heart rate from baseline to12 weeks
Heart rate variability (HRV)
Tidsram: 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)
Change in HRV from baseline to12 weeks
Lung functioning
Tidsram: Change in lung functioning from baseline to12 weeks
Lung functioning measured by spirometry reported in vital capacity (VC)
Change in lung functioning from baseline to12 weeks
Range of motion
Tidsram: Change in range of motion from baseline to12 weeks
Range of motion measured by goniometer reported in degrees
Change in range of motion from baseline to12 weeks
Body composition
Tidsram: 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)
Change in body composition from baseline to12 weeks
Hand grip strength
Tidsram: Change in hand grip strength from baseline to12 weeks
Hand grip strength measured by a dynamometer reported in pounds (lbs)
Change in hand grip strength from baseline to12 weeks
Aerobic fitness
Tidsram: 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)
Change in aerobic fitness from baseline to12 weeks
Physical activity
Tidsram: Change in physical activity from baseline to12 weeks
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)
Tidsram: Change in scores from baseline to12 weeks
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
Tidsram: 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
Change in scores from baseline to12 weeks
Physical health rating
Tidsram: 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)
Change in scores from baseline to12 weeks
Severity of sleep disturbance
Tidsram: Change in scores from baseline to12 weeks
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
Tidsram: Change in scores from baseline to12 weeks
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
Tidsram: 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)
Change in scores from baseline to12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Marquette University

Utredare

  • Huvudutredare: Jacklynn Fitzgerald, PhD, Marquette University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 januari 2022

Primärt slutförande (Faktisk)

27 maj 2022

Avslutad studie (Faktisk)

28 maj 2022

Studieregistreringsdatum

Först inskickad

10 november 2021

Först inskickad som uppfyllde QC-kriterierna

3 januari 2022

Första postat (Faktisk)

5 januari 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 september 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 september 2022

Senast verifierad

1 september 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HR- 3973

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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