NCT00371397

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

July 6, 2011

Completed
Last Updated

July 6, 2016

Status Verified

June 1, 2016

Enrollment Period

3 years

First QC Date

August 31, 2006

Results QC Date

September 16, 2009

Last Update Submit

June 6, 2016

Conditions

Keywords

yogaimmune functionstresshealthmoodskin barrier repair

Outcome Measures

Primary Outcomes (10)

  • Number of Participants With Detectable C-Reactive Protein (CRP)

    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.

    8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart

  • Cortisol

    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.

    Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30

  • Skin Barrier Repair: Trans-epidermal Water Loss (TEWL)

    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.

    11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart

  • Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)

    Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R\&D), per kit instructions.

    Day 1 8:30, 11:35, 13:10. Day 2 7:30

  • Immune Function: Tumor Necrosis Factor-alpha (TNF-α)

    Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R\&D), per kit instructions.

    Day 1 8:30, 11:35, 13:10. Day 2 7:30

  • Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6)

    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).

    Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30

  • Immune Function: LPS-stimulated Production of TNF-α

    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).

    Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30

  • Immune Function: Interleukin-6 (IL-6)

    Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R\&D), per kit instructions

    Day 1 8:30, 11:35, 13:10. Day 2 7:30

  • Catecholamine Production: Epinephrine

    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.

    8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart

  • Catecholamine Production: Norepinephrine

    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.

    8:30, 10:05, 10:28, 10:58, 11:35, 12:05

Secondary Outcomes (4)

  • 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

  • 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

Study Arms (3)

Hatha yoga classes

EXPERIMENTAL

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.

Behavioral: Hatha Yoga Classes

Movement Control

SHAM COMPARATOR

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.

Behavioral: Movement Control

Passive Video Control

NO INTERVENTION

Another control condition, a neutral video that did not include any music, allowed us to contrast the effects of yoga with no activity.The session included a sequence on how to design physics experiments for a high school classroom, as well as segments from two lectures on polymers and quantum mechanics. Groups were counterbalanced to ensure that equal number of novices and experts participated in each possible session combination, in a randomly assigned order.

Interventions

Iyengar yoga, the form of hatha yoga used in this study, emphasizes the use of props to help students achieve precise postures safely and comfortably according to their particular body types and needs. The yoga activity sessions were directed by four experienced yoga teachers following a script. The poses used were (in order) Supta Baddha Konasana (Reclining Bound Angle Pose), Adho Mukha Svanasana (Downward Facing Dog), Supported Uttanasana (Intense Forward Stretch), Parsvotanasana (Intense Side Stretch Pose), Prasarita Padottanansana (Wide-Legged Forward Bend), Janu Sirsasana (Head to Knee Pose), Bharadvajasana (Simple Seated Twist Pose), Viparita Karani (Restful Inversion), Supported Setu Bandha Sarvanagasana (Bridge Pose), and Savasana (Corpse Pose). Blood draws occurred during the last two minutes of Supta Baddha Konasana (pose held 10 minutes), Viparita Karani (10 minutes), and Savasana (15 minutes).

Hatha yoga classes

Walking on a treadmill at .5 miles per hour was used to control for general physical movement/cardiovascular expenditure because it best approximated the heart rates during the restorative yoga session. To match the lower heart rate, women also rested supine on a bed for several minutes after walking, before and after getting their blood drawn.

Movement Control

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Clinical Research Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Kiecolt-Glaser JK, Christian L, Preston H, Houts CR, Malarkey WB, Emery CF, Glaser R. Stress, inflammation, and yoga practice. Psychosom Med. 2010 Feb;72(2):113-21. doi: 10.1097/PSY.0b013e3181cb9377. Epub 2010 Jan 11.

Related Links

Results Point of Contact

Title
Janice Kiecolt-Glaser, PhD
Organization
Ohio State University Institute for Behavioral Medicine Research

Study Officials

  • Janice K. Kiecolt-Glaser, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Institute for Behavioral Medicine Research

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 4, 2006

Study Start

September 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

July 6, 2016

Results First Posted

July 6, 2011

Record last verified: 2016-06

Locations