Psychoneuroimmunology and Mind-Body Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)
研究概览
简要总结
This study is designed to examine the impact of hatha yoga on immune and hormonal functioning in healthy individuals.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy female adults
- •relatively inexperienced with yoga (beginner)
- •experienced with yoga (advanced practitioner)
排除标准
- •Treatment with medication that has immunological or endocrinological consequences
- •Chronic health problems that affect immune or endocrine systems
- •Use of psychoactive drugs or mood-altering medication
- •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.
结局指标
主要结局
Immune Function: Soluble Interleukin-6 Receptor (sIL-6r)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Janice Kiecolt-Glaser
Director, Institute for Behavioral Medicine Research
Ohio State University