The Stress-release Effects of Exercise in Obese Are Determined by DS14 Score and T-cell Activation Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Change in STAIX-1 questionnaire score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obese people without detectable complications of coronary heart disease
排除标准
- •Obese patients with angina pectoris, myocardial infarction, valvular heart disease and congestive heart disease had been excluded from the research.
结局指标
主要结局
Change in STAIX-1 questionnaire score
时间窗: 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.
Change in Cortisol Levels
时间窗: 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.
Change in Heart Rate variability (HRV)
时间窗: 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.
Change from Baseline in DS14 Score at 3 Months
时间窗: 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).
Change in SWLS questionnaire score
时间窗: 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.
Change in Peripheral Human Blood Leucocytes
时间窗: 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.
Change in QOLLTI-P questionnaire score
时间窗: 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.
次要结局
未报告次要终点
研究者
Mateja Hafner M.D.
M.D.
Institute for Preventive Medicine, Trzaska