Yoga, Immune Function, and Health
2016年6月6日 更新者：Janice Kiecolt-Glaser、Ohio State University
Psychoneuroimmunology and Mind-Body Interventions
This study is designed to examine the impact of hatha yoga on immune and hormonal functioning in healthy individuals.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
52
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ohio
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Columbus、Ohio、アメリカ、43210
- Ohio State University Clinical Research Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
30年～65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
Inclusion Criteria:
- healthy female adults
- relatively inexperienced with yoga (beginner)
- experienced with yoga (advanced practitioner)
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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).
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偽コンパレータ：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.
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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.
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介入なし：Passive Video Control
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Detectable C-Reactive Protein (CRP)
時間枠：8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart
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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.
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8:30 a.m. at each of the three visits, scheduled at least 2 weeks apart
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Cortisol
時間枠：Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30
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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.
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Day 1 8:30, 10:05, 10:58, 11:35, 12:05, 13:10. Day 2 7:30
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Skin Barrier Repair: Trans-epidermal Water Loss (TEWL)
時間枠：11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart
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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.
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11:50, 12:50 at each of the three visits, scheduled at least 2 weeks apart
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Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)
時間枠：Day 1 8:30, 11:35, 13:10. Day 2 7:30
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Serum levels of the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.
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Day 1 8:30, 11:35, 13:10. Day 2 7:30
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Immune Function: Tumor Necrosis Factor-alpha (TNF-α)
時間枠：Day 1 8:30, 11:35, 13:10. Day 2 7:30
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Serum levels of TNF-α were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions.
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Day 1 8:30, 11:35, 13:10. Day 2 7:30
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Immune Function: Lipopolysaccharide (LPS) -Stimulated Production of Interleukin-6 (IL-6)
時間枠：Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30
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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).
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Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30
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Immune Function: LPS-stimulated Production of TNF-α
時間枠：Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30
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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).
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Day 1 8:30, 10:05, 11:35, 13:10. Day 2 7:30
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Immune Function: Interleukin-6 (IL-6)
時間枠：Day 1 8:30, 11:35, 13:10. Day 2 7:30
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Serum levels of TNF-α, IL-6, and the sIL-6r were assayed using Quantikine High Sensitivity Immunoassay kits (R&D), per kit instructions
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Day 1 8:30, 11:35, 13:10. Day 2 7:30
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Catecholamine Production: Epinephrine
時間枠：8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart
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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.
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8:30, 10:05, 10:28, 10:58, 11:35, 12:05 at each of the three visits, scheduled at least 2 weeks apart
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Catecholamine Production: Norepinephrine
時間枠：8:30, 10:05, 10:28, 10:58, 11:35, 12:05
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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.
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8:30, 10:05, 10:28, 10:58, 11:35, 12:05
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Heart Rate
時間枠：Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15
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Day 1: 8:30, 9:15, 9:45, 10:00, 10:45, 11:35, 12:05, 12:15
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Blood Pressure
時間枠：7:55 at each of the three visits, scheduled at least 2 weeks apart
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7:55 at each of the three visits, scheduled at least 2 weeks apart
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Mood: Positive and Negative Affect Schedule (PANAS)Positive
時間枠：7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart
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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.
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7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart
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Mood: Positive and Negative Affect Schedule (PANAS)Negative
時間枠：7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart
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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.
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7:35, 11:45, 12:30 at each of the three visits, scheduled at least 2 weeks apart
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Janice K. Kiecolt-Glaser, PhD、Ohio State University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2005年9月1日
一次修了 (実際)
2008年9月1日
研究の完了 (実際)
2008年9月1日
試験登録日
最初に提出
2006年8月31日
QC基準を満たした最初の提出物
2006年8月31日
最初の投稿 (見積もり)
2006年9月4日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年7月6日
QC基準を満たした最後の更新が送信されました
2016年6月6日
最終確認日
2016年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。