- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03710577
Endocannabinoid and Psychological Responses to Yoga in Healthy Adults
16. november 2020 opdateret af: University of Wisconsin, Madison
This study evaluates the acute effect of yoga on plasma levels of endocannabinoids and mood (i.e., mood disturbance, anxiety, pain) compared to one session of quiet rest.
Participants completed one session of yoga and one session of quiet rest on two separate days.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53706
- University of Wisconsin-Madison Natatorium
-
-
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 til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- greater than or equal to 18 years old and < 45 years old and
- report being healthy.
Exclusion Criteria:
- Being pregnant or planning to become pregnant,
- currently smoking,
- having a history of light headedness or fainting during blood draws or physical activity,
- having a history of chest pain during physical activity,
- having a bone, joint, cardiac, or other medical condition that a doctor has said may be worsened by physical activity,
- taking medications for any chronic diseases such as high blood pressure or diabetes,
- responding 'Yes' to any of the seven questions on the Par-Q.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Yoga
40 minutes of Vinyasa yoga
|
1 session
|
|
Placebo komparator: Quiet Rest
40 minutes of quiet rest
|
1 session
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Plasma Concentration of N-arachidonoylethanolamine
Tidsramme: This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)
|
Plasma concentration of anandamide, one effector of the endocannabinoid system
|
This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)
|
|
Change in Plasma Concentration of 2-Arachidonoylglycerol (2-AG)
Tidsramme: This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)
|
Plasma concentration of 2-AG, one effector of the endocannabinoid system
|
This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Total Mood Disturbance as Measured by the Profile of Mood States
Tidsramme: This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)
|
65-item self-reported mood questionnaire that measures mood "right now."
Scores range from 0-200 with higher scores indicating higher mood disturbance.
|
This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)
|
|
Change in State Anxiety as Measured by the State-Trait Anxiety Inventory
Tidsramme: This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)
|
20-item self-reported anxiety questionnaire that measures anxiety "right now."
Scores range from 20-80 with higher scores indicating higher anxiety.
|
This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)
|
|
Change in Total Pain as Measured by the Short-form McGill Pain Questionnaire
Tidsramme: This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)
|
15-item self-reported pain questionnaire that measures pain "right now."
Scores range from 0-45 with higher scores indicating higher pain.
|
This will be measured 2 times during each study visit, once before the assigned study task (i.e., baseline) and once upon task completion (i.e., approx. 40 min. later)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kelli Koltyn, PhD, University of Wisconsin, Madison
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)
12. december 2017
Primær færdiggørelse (Faktiske)
16. maj 2018
Studieafslutning (Faktiske)
16. maj 2018
Datoer for studieregistrering
Først indsendt
21. juni 2018
Først indsendt, der opfyldte QC-kriterier
15. oktober 2018
Først opslået (Faktiske)
18. oktober 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. december 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2017-0980
- A176000 (Anden identifikator: UW- Madison)
- EDUC/KINESIOLOGY/KINESIO (Anden identifikator: UW Madison)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .