Yoga, Immune Function, and Health

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00371397
First received: August 31, 2006
Last updated: June 7, 2011
Last verified: June 2011
Results First Received: September 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Healthy
Interventions: Behavioral: Hatha Yoga Classes
Behavioral: Movement Control

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Women were recruited through online ads and notices posted in yoga studios. All women participated in some form of hatha yoga.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Expert: Movement Control Then Hatha Yoga Then Video

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.
Expert: Hatha Yoga Then Video Then Movement Control

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.
Expert: Video Then Movement Control Then Hatha Yoga

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.
Expert: Movement Control Then Video Then Hatha Yoga

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.
Expert: Hatha Yoga Then Movement Control Then Video

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.
Expert: Video Then Hatha Yoga Then Movement Control

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.
Novice: Movement Control Then Hatha Yoga Then Video

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.
Novice: Hatha Yoga Then Video Then Movement Control

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.
Novice: Video Then Movement Control Then Hatha Yoga

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.
Novice: Movement Control Then Video Then Hatha Yoga

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.
Novice: Hatha Yoga Then Movement Control Then Video

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.
Novice: Video Then Hatha Yoga Then Movement Control

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.

Participant Flow for 3 periods

Period 1:   Session 1
    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  
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  
Withdrawal by Subject                 1                 0                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0  

Period 2:   Session 2
    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  
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 3:   Session 3
    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  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Overall Study 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.

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
  52  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     52  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.32  ± 10.33  
Gender  
[units: participants]
 
Female     52  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     52  



  Outcome Measures

1.  Primary:   Number of Participants With Detectable C-Reactive Protein (CRP)   [ Time Frame: 8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart ]

2.  Primary:   Cortisol   [ Time Frame: Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Primary:   Skin Barrier Repair: Trans-epidermal Water Loss (TEWL)   [ Time Frame: 11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Primary:   Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)   [ Time Frame: Day 1 8:30, 11:35, 13:10. Day 2 7:30 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Primary:   Immune Function: Tumor Necrosis Factor-alpha (TNF-α)   [ Time Frame: Day 1 8:30, 11:35, 13:10. Day 2 7:30 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Primary:   Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6)   [ Time Frame: Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Primary:   Immune Function: LPS-stimulated Production of TNF-α   [ Time Frame: Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Primary:   Immune Function: Interleukin-6 (IL-6)   [ Time Frame: Day 1 8:30, 11:35, 13:10. Day 2 7:30 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Primary:   Catecholamine Production: Epinephrine   [ 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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Primary:   Catecholamine Production: Norepinephrine   [ Time Frame: 8:30, 10:05, 10:28, 10:58, 11:35, 12:05 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Heart Rate   [ Time Frame: Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Blood Pressure   [ Time Frame: 7:55 at each of the three visits, scheduled at least 2 weeks apart ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Mood: Positive and Negative Affect Schedule (PANAS)Positive   [ Time Frame: 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Mood: Positive and Negative Affect Schedule (PANAS)Negative   [ Time Frame: 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Janice Kiecolt-Glaser, PhD
Organization: Ohio State University Institute for Behavioral Medicine Research
phone: 614-292-0033
e-mail: Kiecolt-Glaser.1@osu.edu


Publications of Results:

Responsible Party: Janice Kiecolt-Glaser, PhD, Ohio State University Department of Psychiatry
ClinicalTrials.gov Identifier: NCT00371397     History of Changes
Other Study ID Numbers: 2005H0068, R21AT002971-01
Study First Received: August 31, 2006
Results First Received: September 16, 2009
Last Updated: June 7, 2011
Health Authority: United States: Federal Government