HealthyNCT00371397
Yoga, Immune Function, and Health
A study testing Hatha Yoga Classes in people with Healthy, run by Ohio State University at 1 site in United States.
Trial summary
This study is designed to examine the impact of hatha yoga on immune and hormonal functioning in healthy individuals. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hatha Yoga Classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy female adults
- relatively inexperienced with yoga (beginner)
- experienced with yoga (advanced practitioner)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Clinical Research Center
Columbus, Ohio, 43210
About this study
Official title: Psychoneuroimmunology and Mind-Body Interventions
This study is designed to examine the impact of hatha yoga on immune and hormonal functioning in healthy individuals.
Read the 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.
- Conditions
- Healthy
- Being tested
- Hatha Yoga Classes, Movement Control
- Keywords
- yoga, immune function, stress, health, mood, skin barrier repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha Yoga ClassesBehavioural
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).
Movement ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 8:30, 10:05, 10:28, 10:58, 11:35, 12:05
Secondary outcomes (4)
Heart Rate
Measured: Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15
Blood Pressure
Measured: 7:55 at each of the three visits, scheduled at least 2 weeks apart
Mood: Positive and Negative Affect Schedule (PANAS)Positive
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.
Measured: 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
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.
Measured: 7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startSep 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Janice Kiecolt-Glaser, Ohio State University
- Investigators
- Janice K. Kiecolt-Glaser, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371397
- Sponsor's protocol ID
- 2005H0068
- Other IDs
- R21AT002971-01
- Status last verified
- Jun 2016
- First submitted
- 31 Aug 2006
- Last updated
- 6 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20064902
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoneuroimmunology and Mind-Body Interventions
- ClinicalTrials.gov ID
- NCT00371397
- Acronym / sponsor ID
- 2005H0068
- Conditions
- Healthy
- Keywords
- yoga, immune function, stress, health, mood, skin barrier repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Posted 6 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hatha yoga classes | Experimental | Behavioral: Hatha Yoga ClassesGroups 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 | Sham comparator | Behavioral: Movement ControlNon-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. |
| 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy female adults
- relatively inexperienced with yoga (beginner)
- experienced with yoga (advanced practitioner)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hatha Yoga ClassesIyengar 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). | Behavioural | Hatha yoga classes |
| Movement ControlWalking 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. | Behavioural | Movement Control |
Primary outcome
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
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
Time frame: 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)
Time frame: 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: Soluble Interleukin-6 Receptor (sIL-6r)
Time frame: 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: Tumor Necrosis Factor-alpha (TNF-α)
Time frame: 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: 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
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: LPS-stimulated Production of TNF-α
Time frame: 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)
Time frame: 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
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
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
Time frame: 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.
4 secondary outcomes
Heart Rate
Time frame: Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15
Blood Pressure
Time frame: 7:55 at each of the three visits, scheduled at least 2 weeks apart
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
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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20064902Kiecolt-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.
- Please click here to visit our website if you would like to read more about our studies.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice K. Kiecolt-Glaser, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha Yoga Classes in people with Healthy, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00371397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.