NCT03710577

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 21, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 26, 2020

Completed
Last Updated

December 8, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

June 21, 2018

Results QC Date

September 30, 2020

Last Update Submit

November 16, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Plasma Concentration of N-arachidonoylethanolamine

    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)

    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)

Secondary Outcomes (3)

  • Change in Total Mood Disturbance as Measured by the Profile of Mood States

    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

    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

    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)

Study Arms (2)

Yoga

EXPERIMENTAL

40 minutes of Vinyasa yoga

Behavioral: Yoga

Quiet Rest

PLACEBO COMPARATOR

40 minutes of quiet rest

Behavioral: Quiet Rest

Interventions

YogaBEHAVIORAL

1 session

Yoga
Quiet RestBEHAVIORAL

1 session

Quiet Rest

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • greater than or equal to 18 years old and \< 45 years old and
  • report being healthy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison Natatorium

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Results Point of Contact

Title
Dr. Kelli Koltyn
Organization
Univerisity of Wisconsin-Madison

Study Officials

  • Kelli Koltyn, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The proposed study is an acute, single group, crossover pilot study where participants will complete control and experimental conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2018

First Posted

October 18, 2018

Study Start

December 12, 2017

Primary Completion

May 16, 2018

Study Completion

May 16, 2018

Last Updated

December 8, 2020

Results First Posted

October 26, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations