The Stress-release Effects of Exercise in Obese Are Determined by DS14 Score and T-cell Activation Status
2015年7月8日 更新者：Mateja Hafner M.D.、Institute for Preventive Medicine, Trzaska
The purpose of the study was to analyze negative affectivity (NA) and social inhibition (SI) inquired by DS14 score in type D personality (distressed personality) to the relation of autonomic regulation of heart function (HRV) and immune response (T lymphocyte) among obese patients within coronary heart disease group (CHD).
As stress is the key psychological activator of the hypothalamic-pituitary-adrenal axis (HPA axis) and therefore an important risk factor for diminished immune competency and prevalence of chronic conditions such as obesity, investigators chose exercise as the stress release intervention, especially as chronic stress may have a role in obesity, related to initiation or exacerbation of the condition.
Abnormal regulation of the hypothalamic-pituitary-adrenal axis is additionally associated with chronic inflammatory conditions.
Proinflammatory T-lymphocytes are present in visceral adipose tissue and may contribute to local inflammatory cell activation before the appearance of macrophages, suggesting that these cells could play an important role in the initiation and perpetuation of adipose tissue inflammation.
研究概览
详细说明
This study was performed at The Institute for Preventive Medicine in cooperation with The Institute of Microbiology and Immunology at the Medical Faculty of Ljubljana/University of Ljubljana in a clinical setting as an observational type.
In the group of examinees the investigators chose only those obese without detectable complications of coronary heart disease while admitted.
Obese patients with angina pectoris, myocardial infarction, valvular heart disease and congestive heart disease had been excluded from the research.
Since personality is the major determinant of chronic stress, according to the investigators hypothesis, further division on two global traits Negative affectivity (NA) and Social inhibition (SI) structured by Denollet has been positioned in the study.
A total of 30 patients with CHD were divided in two groups.
Participants who were obese with high DS14 score matched obese controls with normal DS14 score.
In all subjects the investigators also observed white blood cell counts with a detailed lymphocyte analysis using flow cytometry and C-reactive protein (CRP) as the indicator of inflammation.
Besides body mass (BM), body mass index (BMI) systolic and diastolic blood pressure (SBP, DBP), heart rate (HR), and heart rate variability (HRV) were measured before and after three months period, while all subjects had been already exercising 4 times weakly (moderate walking of 5km/h) for an hour.
Additionally STAIX-1, SWLS and QOLLTI-P questionnaires had been used.
研究类型
观察性的
注册 (实际的)
30
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
30 examinees, 14 men of average age 56,3 ± 15,5 years old and 16 women of average age of 53,5.
± 4,2 years old made the owerweight/obese group of chronic (coronary heart disease) patients.
Subjects were matched by gender, age, body mass index and had all been regular visitors (patients) of The Institute of Preventive Medicine.
描述
Inclusion Criteria:
- obese people without detectable complications of coronary heart disease
Exclusion Criteria:
- Obese patients with angina pectoris, myocardial infarction, valvular heart disease and congestive heart disease had been excluded from the research.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Group A
observational time of three months in the obese group with distressed (type D) personality (high DS 14 score) with moderate aerobic exercise
|
|
Group B
observational time of three months in obese group without distressed personality (low DS 14 score) with moderate aerobic exercise
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in DS14 Score at 3 Months
大体时间：baseline and 3 months
|
Each examines filled in DS14 scale to determine negative affectivity (NA), social inhibition (SI) and Type D personality for early identification of high-risk CHD patients (Denollet, 2005).
Subjects rated their personality on a 5-point Likert scale ranging from 0 _ false to 4 _true.
The NA and SI scales can be scored as continuous variables (range, 0-28) to assess these personality traits in their own right.
A cutoff of 10 on both scales is used to classify subjects as Type D (NA _10 and SI _10).
|
baseline and 3 months
|
|
Change in STAIX-1 questionnaire score
大体时间：baseline and 3 months
|
The STAIX-1 Form is an administered analysis of reported anxiety symptoms. The first subscale measures state anxiety, the second measures trait anxiety. The range of scores is 20-80, the higher the score indicating greater anxiety. |
baseline and 3 months
|
|
Change in Peripheral Human Blood Leucocytes
大体时间：baseline and 3 months
|
Peripheral human blood leucocytes were collected by the venipuncture procedure and collected into Vacutainers.Two-parameter analysis was performed to determine the proportion of T cells (CD3+), T helper cells (CD3+CD4+) and cytotoxic T cells (CD3+CD8+).
Isotype controls (Becton Dickinson, Mountain View, CA) and a control of viable cells (LIVE/DEAD kit, Molecular Probes, OR) were included.
At least 2000 gated cells were analyzed for each test, and signals from two light scatters and four fluorescence parameters were analyzed with the Becton Dickinson Lysis II software.
|
baseline and 3 months
|
|
Change in Cortisol Levels
大体时间：baseline and 3 months
|
The measurement of cortisol in salivary samples accurately reflects levels of physiologically active unbound (free) cortisol in the blood, which diffuses from the blood to saliva.
|
baseline and 3 months
|
|
Change in Heart Rate variability (HRV)
大体时间：baseline and 3 months
|
The investigators chose the combination of Time domain methods and Frequency domain methods to compare variability among groups under physical exercise and within 24 hours.
|
baseline and 3 months
|
|
Change in SWLS questionnaire score
大体时间：baseline and 3 months
|
The Satisfaction With Life Scale (SWLS) is a measure of life satisfaction.
Life satisfaction can be assessed specific to a particular domain of life (e.g., work, family) or globally.
The SWLS is a global measure of life satisfaction.
|
baseline and 3 months
|
|
Change in QOLLTI-P questionnaire score
大体时间：baseline and 3 months
|
The Quality of Life in Life-Threatening Illness-Patient questionnaire (QOLLTI-P) is a self-administered questionnaire based on the McGill Quality of Life questionnaire (MQOL) with domains added to enhance content validity.
Participants were asked to complete a set of above questionnaires prior to immunological assessment and HRV measurement.
|
baseline and 3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mateja Hafner, M.D.、Institute of Preventive medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Thayer JF, Ahs F, Fredrikson M, Sollers JJ 3rd, Wager TD. A meta-analysis of heart rate variability and neuroimaging studies: implications for heart rate variability as a marker of stress and health. Neurosci Biobehav Rev. 2012 Feb;36(2):747-56. doi: 10.1016/j.neubiorev.2011.11.009. Epub 2011 Dec 8.
- Thayer JF, Sternberg E. Beyond heart rate variability: vagal regulation of allostatic systems. Ann N Y Acad Sci. 2006 Nov;1088:361-72. doi: 10.1196/annals.1366.014.
- Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007.
- Suwa A, Shimokawa T. Emerging targets for the treatment of obesity. FEBS J. 2011 Feb;278(4):551. doi: 10.1111/j.1742-4658.2010.07981.x. Epub 2010 Dec 30. No abstract available.
- Kintscher U, Hartge M, Hess K, Foryst-Ludwig A, Clemenz M, Wabitsch M, Fischer-Posovszky P, Barth TF, Dragun D, Skurk T, Hauner H, Bluher M, Unger T, Wolf AM, Knippschild U, Hombach V, Marx N. T-lymphocyte infiltration in visceral adipose tissue: a primary event in adipose tissue inflammation and the development of obesity-mediated insulin resistance. Arterioscler Thromb Vasc Biol. 2008 Jul;28(7):1304-10. doi: 10.1161/ATVBAHA.108.165100. Epub 2008 Apr 17.
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- Denollet J, Sys SU, Brutsaert DL. Personality and mortality after myocardial infarction. Psychosom Med. 1995 Nov-Dec;57(6):582-91. doi: 10.1097/00006842-199511000-00011.
- Denollet J, Sys SU, Stroobant N, Rombouts H, Gillebert TC, Brutsaert DL. Personality as independent predictor of long-term mortality in patients with coronary heart disease. Lancet. 1996 Feb 17;347(8999):417-21. doi: 10.1016/s0140-6736(96)90007-0.
- Ferguson E, Ward JW, Skatova A, Cassaday HJ, Bibby PA, Lawrence C. Health specific traits beyond the Five Factor Model, cognitive processes and trait expression: replies to Watson (2012), Matthews (2012) and Haslam, Jetten, Reynolds, and Reicher (2012). Health Psychol Rev. 2013 May;7(Suppl 1):S85-S103. doi: 10.1080/17437199.2012.701061. Epub 2013 May 28.
- Piestrzeniewicz K, Luczak K, Lelonek M, Wranicz JK, Goch JH. Obesity and heart rate variability in men with myocardial infarction. Cardiol J. 2008;15(1):43-9.
- Lee DC, Pate RR, Lavie CJ, Sui X, Church TS, Blair SN. Leisure-time running reduces all-cause and cardiovascular mortality risk. J Am Coll Cardiol. 2014 Aug 5;64(5):472-81. doi: 10.1016/j.jacc.2014.04.058. Erratum In: J Am Coll Cardiol. 2014 Oct 7;64(14):1537.
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- Malfatto G, Facchini M, Sala L, Branzi G, Bragato R, Leonetti G. Effects of cardiac rehabilitation and beta-blocker therapy on heart rate variability after first acute myocardial infarction. Am J Cardiol. 1998 Apr 1;81(7):834-40. doi: 10.1016/s0002-9149(98)00021-6.
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- Yasuma F, Hayano J. Respiratory sinus arrhythmia: why does the heartbeat synchronize with respiratory rhythm? Chest. 2004 Feb;125(2):683-90. doi: 10.1378/chest.125.2.683.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年1月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2014年3月1日
研究注册日期
首次提交
2015年7月1日
首先提交符合 QC 标准的
2015年7月8日
首次发布 (估计)
2015年7月9日
研究记录更新
最后更新发布 (估计)
2015年7月9日
上次提交的符合 QC 标准的更新
2015年7月8日
最后验证
2015年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.