The Stress-release Effects of Exercise in Obese Are Determined by DS14 Score and T-cell Activation Status

Obesity Clinical Trial

Official title:

The Stress-release Effects of Exercise in Obese Are Determined by DS14 Score and T-cell Activation Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493413
• Other study ID #: 001563777
• Status: Completed
• Phase: N/A
• First received: July 1, 2015
• Last updated: July 8, 2015
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: July 2015
• Source: Institute for Preventive Medicine, Trzaska
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia
• Obesity
• Type D Personality

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Preventive Medicine, Trzaska	University of Ljubljana

References & Publications (22)

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Denollet J. DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med. 2005 Jan-Feb;67(1):89-97. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in DS14 Score at 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	No
Primary	Change in STAIX-1 questionnaire score	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	No
Primary	Change in Peripheral Human Blood Leucocytes	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	No
Primary	Change in Cortisol Levels	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	No
Primary	Change in Heart Rate variability (HRV)	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	No
Primary	Change in SWLS questionnaire score	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	No
Primary	Change in QOLLTI-P questionnaire score	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	No