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Yoga, Immune Function, and Health

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Janice Kiecolt-Glaser, Ohio State University
ClinicalTrials.gov Identifier:
NCT00371397
First received: August 31, 2006
Last updated: June 6, 2016
Last verified: June 2016
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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


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


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, Ohio State University
ClinicalTrials.gov Identifier: NCT00371397     History of Changes
Other Study ID Numbers: 2005H0068
R21AT002971-01 ( US NIH Grant/Contract Award Number )
Study First Received: August 31, 2006
Results First Received: September 16, 2009
Last Updated: June 6, 2016
Health Authority: United States: Federal Government