Feasibility of a Yoga Program for Veterans With PTSD
2. september 2022 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53207
- Marquette University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Endocannabinoid assay
Tidsramme: Change in ligands from baseline to12 weeks
|
Endocannabinoid ligands reported in ng/ml
|
Change in ligands from baseline to12 weeks
|
|
Cortisol assay
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jacklynn Fitzgerald, PhD, Marquette University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. januar 2022
Primær færdiggørelse (Faktiske)
27. maj 2022
Studieafslutning (Faktiske)
28. maj 2022
Datoer for studieregistrering
Først indsendt
10. november 2021
Først indsendt, der opfyldte QC-kriterier
3. januar 2022
Først opslået (Faktiske)
5. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. september 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. september 2022
Sidst verificeret
1. september 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HR- 3973
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