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Yoga, Immune Function, and Health

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ClinicalTrials.gov Identifier: NCT00371397
Recruitment Status : Completed
First Posted : September 4, 2006
Results First Posted : July 6, 2011
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Janice Kiecolt-Glaser, Ohio State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Healthy
Interventions Behavioral: Hatha Yoga Classes
Behavioral: Movement Control
Enrollment 52
Recruitment Details Women were recruited through online ads and notices posted in yoga studios. All women participated in some form of hatha yoga.
Pre-assignment Details  
Arm/Group Title Expert: Movement Control Then Hatha Yoga Then Video Expert: Hatha Yoga Then Video Then Movement Control Expert: Video Then Movement Control Then Hatha Yoga Expert: Movement Control Then Video Then Hatha Yoga Expert: Hatha Yoga Then Movement Control Then Video Expert: Video Then Hatha Yoga Then Movement Control Novice: Movement Control Then Hatha Yoga Then Video Novice: Hatha Yoga Then Video Then Movement Control Novice: Video Then Movement Control Then Hatha Yoga Novice: Movement Control Then Video Then Hatha Yoga Novice: Hatha Yoga Then Movement Control Then Video Novice: Video Then Hatha Yoga Then Movement Control
Hide Arm/Group Description

Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.

  • For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning.

Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.

  • For Session 1, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning.

Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.

  • For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 3, participants completed the Hatha Yoga Class in 1 day and a 30 minute follow-up session the next morning.

Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.

  • For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning.

Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.

  • For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning.

Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.

  • For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.

Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.

  • For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning.

Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.

  • For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning.

Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.

  • For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning.

Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.

  • For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning.

Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.

  • For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.
  • For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.

Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.

  • For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.
  • For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.
Period Title: Session 1
Started 5 7 5 2 3 4 4 5 6 5 4 2
Completed 4 7 5 2 3 4 4 4 6 5 4 2
Not Completed 1 0 0 0 0 0 0 1 0 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0             0             0             0             1             0             0             0             0
Period Title: Session 2
Started 4 7 5 2 3 4 4 4 6 5 4 2
Completed 4 7 5 2 3 4 4 4 6 5 4 2
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Session 3
Started 4 7 5 2 3 4 4 4 6 5 4 2
Completed 4 7 5 2 3 4 4 4 6 5 4 2
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Overall Study
Hide Arm/Group Description Women were exposed to each of the conditions (yoga, movement control, and passive-video control) during three separate visits. The order of the visits was randomized per participant. 52 total participants enrolled.
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
<=18 years
0
   0.0%
Between 18 and 65 years
52
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants
41.32  (10.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
52
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants
52
1.Primary Outcome
Title Number of Participants With Detectable C-Reactive Protein (CRP)
Hide Description High sensitivity C-reactive protein (hsCRP) assessed once at baseline, at each of the three visits. The hsCRP assay was performed using chemiluminescence methodology with the Immulite 1000 (Siemens Medical Solutions, Los Angeles, Ca.) The lowest level of detection is .3 mg/dL. 43% of the values were below this lower bound, thus hsCRP was dichotomized as undetectable/detectable.
Time Frame 8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Novice Expert
Hide Arm/Group Description:
Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: participants with CRP above 0.3
16 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Novice, Expert
Comments hsCRP dichotomized as undetectable/detectable. Logistic regression w/generalized estimating equations(GEE)s to determine odds ratio. Assessed hsCRP at baseline at each of the three visits; 43% of the values (n = 65) were below the assay's detectable lower bound of .3 mg/dL, and thus hsCRP was dichotomized as undetectable/detectable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .009
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.75
Estimation Comments [Not Specified]
2.Primary Outcome
Title Cortisol
Hide Description All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.
Time Frame Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30
Outcome Measure Data Not Reported
3.Primary Outcome
Title Skin Barrier Repair: Trans-epidermal Water Loss (TEWL)
Hide Description Cellophane tape stripping, a common dermatological paradigm for studying restoration of the skin barrier, was used to examine whether the time necessary for recovery from minor physical insults varied by condition or yoga expertise. Measurement of the rate of transepidermal water loss (TEWL) through human skin provides a noninvasive method to monitor changes in the skin's barrier function. TEWL was measured twice during the session using a computerized evaporimetry instrument, the DermaLab® (CyberDERM, Media, PA), and barrier recovery was calculated.
Time Frame 11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart
Outcome Measure Data Not Reported
4.Primary Outcome
Title Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)
Hide Description Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.
Time Frame Day 1 8:30, 11:35, 13:10. Day 2 7:30
Outcome Measure Data Not Reported
5.Primary Outcome
Title Immune Function: Tumor Necrosis Factor-alpha (TNF-α)
Hide Description Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.
Time Frame Day 1 8:30, 11:35, 13:10. Day 2 7:30
Outcome Measure Data Not Reported
6.Primary Outcome
Title Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6)
Hide Description Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).
Time Frame Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30
Outcome Measure Data Not Reported
7.Primary Outcome
Title Immune Function: LPS-stimulated Production of TNF-α
Hide Description Supernatants from PBLs stimulated with 5μg/ml lipopolysaccharide (LPS) for 72 h were assayed for IL-6 and TNF-α using ELISA kits (B-D Pharmingen).
Time Frame Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30
Outcome Measure Data Not Reported
8.Primary Outcome
Title Immune Function: Interleukin-6 (IL-6)
Hide Description Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions
Time Frame Day 1 8:30, 11:35, 13:10. Day 2 7:30
Outcome Measure Data Not Reported
9.Primary Outcome
Title Catecholamine Production: Epinephrine
Hide Description All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.
Time Frame 8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart
Outcome Measure Data Not Reported
10.Primary Outcome
Title Catecholamine Production: Norepinephrine
Hide Description All cortisol and catecholamine samples for a subject were frozen after collection and analyzed within the same assay run after the participant had completed the study.
Time Frame 8:30, 10:05, 10:28, 10:58, 11:35, 12:05
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Heart Rate
Hide Description [Not Specified]
Time Frame Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Blood Pressure
Hide Description [Not Specified]
Time Frame 7:55 at each of the three visits, scheduled at least 2 weeks apart
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Mood: Positive and Negative Affect Schedule (PANAS)Positive
Hide Description The Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.
Time Frame 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Mood: Positive and Negative Affect Schedule (PANAS)Negative
Hide Description The Positive and Negative Affect Schedule (PANAS) includes two 10-item mood scales. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely, to indicate the extent to which the respondent has felt this way in the indicated time frame. Several additional words were added to better capture low positive affect: happy, satisfied, disappointed, discouraged, low, sad.
Time Frame 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Novice Expert
Hide Arm/Group Description Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions. Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
All-Cause Mortality
Novice Expert
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Novice Expert
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/26 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Novice Expert
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/26 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Janice Kiecolt-Glaser, PhD
Organization: Ohio State University Institute for Behavioral Medicine Research
Phone: 614-292-0033
EMail: Kiecolt-Glaser.1@osu.edu
Layout table for additonal information
Responsible Party: Janice Kiecolt-Glaser, Ohio State University
ClinicalTrials.gov Identifier: NCT00371397    
Other Study ID Numbers: 2005H0068
R21AT002971-01 ( U.S. NIH Grant/Contract )
First Submitted: August 31, 2006
First Posted: September 4, 2006
Results First Submitted: September 16, 2009
Results First Posted: July 6, 2011
Last Update Posted: July 6, 2016