Yoga, Immune Function, and Health

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: Hatha Yoga Classes; Behavioral: Movement Control

• Registration Number: NCT00371397
• Lead Sponsor: Ohio State University

Brief Summary

This study is designed to examine the impact of hatha yoga on immune and hormonal functioning in healthy individuals.

Detailed Description

This study is designed to examine the effects of hatha yoga on autonomic, immune, and endocrine function. The data from both inexperienced and experienced groups will help us better understand how longer-term practice of yoga may be beneficial. The study consists of one 3-hour screening session and three 6-hour activity sessions with 30 minute follow-up appointments the following morning scheduled 2 - 4 weeks apart. Each participant will complete the 3 activity sessions, which will consist of either yoga, mild movement, or a neutral activity (watching a videotape), in randomly assigned order. Thus, both novices and experts will participate in 3 activity sessions each (yoga, movement control, video control). The order in which each participant goes through the activity sessions is counterbalanced. Data for each activity session will be aggregated by group (i.e. novice or expert). We will measure responses to tape stripping to assess skin barrier repair, and evaluate responses to computer tasks, self-report measures, and a battery of unobtrusive behavioral measures. We will also collect blood and saliva samples to measure immune and endocrine outcomes.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-08-31
• Study First Submitted QC: 2006-08-31
• Study First Posted: 2006-09-04
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-09-16
• Results First Submitted QC: 2011-06-07
• Results First Posted: 2011-07-06
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-06
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• healthy female adults
• relatively inexperienced with yoga (beginner)
• experienced with yoga (advanced practitioner)

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Exclusion Criteria

• Treatment with medication that has immunological or endocrinological consequences
• Chronic health problems that affect immune or endocrine systems
• Anemia
• Use of psychoactive drugs or mood-altering medication
• Smoking
• Needle or blood phobias
• Tape or bandage allergies
• Pregnancy or nursing within the previous 3 months
• Heart problems
• History of hip or knee replacement surgery, displaced vertebrae, and any other physical limitations that would prevent full participation in the program
• use of statins, beta blockers
• excessive alcohol use
• convulsive disorders
• Body Mass Index (BMI) ≥ 30.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hatha yoga classes	Hatha Yoga Classes	Groups consisted of novices or experts. Groups were counterbalanced to ensure that equal number of novices and experts participated in each possible session combination, in a randomly assigned order.
Movement Control	Movement Control	Non-Hatha yoga gentle movement. Groups consisted of novices or experts. Groups were counterbalanced to ensure that equal number of novices and experts participated in each possible session combination, in a randomly assigned order.

Primary Outcome Measures

Name	Time	Method
Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)	Day 1 8:30, 11:35, 13:10. Day 2 7:30	Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R\&D), per kit instructions.
Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6)	Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30	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).
Number of Participants With Detectable C-Reactive Protein (CRP)	8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart	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.
Cortisol	Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30	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.
Skin Barrier Repair: Trans-epidermal Water Loss (TEWL)	11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart	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.
Immune Function: Tumor Necrosis Factor-alpha (TNF-α)	Day 1 8:30, 11:35, 13:10. Day 2 7:30	Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R\&D), per kit instructions.
Immune Function: LPS-stimulated Production of TNF-α	Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30	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).
Immune Function: Interleukin-6 (IL-6)	Day 1 8:30, 11:35, 13:10. Day 2 7:30	Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R\&D), per kit instructions
Catecholamine Production: Epinephrine	8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart	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.
Catecholamine Production: Norepinephrine	8:30, 10:05, 10:28, 10:58, 11:35, 12:05	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.

Secondary Outcome Measures

Name	Time	Method
Heart Rate	Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15
Blood Pressure	7:55 at each of the three visits, scheduled at least 2 weeks apart
Mood: Positive and Negative Affect Schedule (PANAS)Positive	7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart	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.
Mood: Positive and Negative Affect Schedule (PANAS)Negative	7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart	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.

Trial Locations

Locations (1)

Ohio State University Clinical Research Center; 🇺🇸 Columbus, Ohio, United States