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| ID | Type | Description | Link |
|---|---|---|---|
| A176000 | Other Identifier | UW, Madison | |
| EDUC/KINESIOLOGY/KINESIO | Other Identifier | UW, Madison |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga | Experimental | 40 minutes of Vinyasa yoga |
|
| Quiet Rest | Placebo Comparator | 40 minutes of quiet rest |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Behavioral | 1 session |
| |
| Quiet Rest |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Mood Disturbance as Measured by the Profile of Mood States | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli Koltyn, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison Natatorium | Madison | Wisconsin | 53706 | United States |
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Volunteer eligibility was determined through a preliminary phone screen, participants were randomly assigned to receive the experimental task (Yoga) or the control task (quiet rest) first. Participants will then cross over 2-5 days after their first task to act as their own controls.
Volunteers were recruited from students, faculty, and staff at the University of Wisconsin - Madison to participate in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Yoga, Then Quiet Rest | 40 minutes of Vinyasa yoga Yoga: 1 session 2-5 days between sessions 40 minutes of quiet rest Quiet Rest: 1 session |
| FG001 | Quiet Rest, Then Yoga | 40 minutes of quiet rest Quiet Rest: 1 session 2-5 days between sessions 40 minutes of Yoga Yoga: 1 session |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Time Between Sessions (2-5 Days) |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Yoga, the Quiet Rest | 40 minutes of Vinyasa yoga Yoga: 1 session 2-5 days between sessions 40 minutes of Quiet Rest Quiet Rest: 1 session |
| BG001 | Quiet Rest, Then Yoga | 40 minutes of quiet rest Quiet Rest: 1 session 2-5 days between sessions 40 minutes of Yoga Yoga: 1 session |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Plasma Concentration of N-arachidonoylethanolamine | Plasma concentration of anandamide, one effector of the endocannabinoid system | All participants for whom plasma samples were taken at baseline and post exercise | Posted | Mean | Standard Deviation | pmol/mL | 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) |
|
Participants were monitored for adverse events while completing the research protocol on-site (i.e., 2 sessions on separate days, lasting about 1 hour each).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yoga | 40 minutes of Vinyasa yoga Yoga: 1 session | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kelli Koltyn | Univerisity of Wisconsin-Madison | 608-262-4234 | koltyn@education.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2018 | Jun 20, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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The proposed study is an acute, single group, crossover pilot study where participants will complete control and experimental conditions.
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| Behavioral |
1 session |
|
| Change in State Anxiety as Measured by the State-Trait Anxiety Inventory | 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 | 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) |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants who marked their Ethnicity as 'Hispanic or Latino' also marked their Race as 'Hispanic or Latino'. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Change in Plasma Concentration of 2-Arachidonoylglycerol (2-AG) | Plasma concentration of 2-AG, one effector of the endocannabinoid system | All participants for whom plasma samples were taken at baseline and post exercise | Posted | Mean | Standard Deviation | pmol/mL | 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 | Change in Total Mood Disturbance as Measured by the Profile of Mood States | 65-item self-reported mood questionnaire that measures mood "right now." Scores range from 0-200 with higher scores indicating higher mood disturbance. | All participants who completed the Profile of Mood States. | Posted | Mean | Standard Deviation | score on a scale | 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 | Change in State Anxiety as Measured by the State-Trait Anxiety Inventory | 20-item self-reported anxiety questionnaire that measures anxiety "right now." Scores range from 20-80 with higher scores indicating higher anxiety. | All participants who completed the State-Trait Anxiety Inventory. | Posted | Mean | Standard Deviation | score on a scale | 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 | Change in Total Pain as Measured by the Short-form McGill Pain Questionnaire | 15-item self-reported pain questionnaire that measures pain "right now." Scores range from 0-45 with higher scores indicating higher pain. | All participants who completed the Short-form McGill Pain Questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Quiet Rest | 40 minutes of quiet rest Quiet Rest: 1 session | 0 | 12 | 0 | 12 | 0 | 12 |
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| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |