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

NCT ID: NCT02493413

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-03-31

Brief 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.

Detailed 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.

Conditions

Obesity; Type D Personality; Coronary Heart Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

observational time of three months in the obese group with distressed (type D) personality (high DS 14 score) with moderate aerobic exercise

No interventions assigned to this group

Group B

observational time of three months in obese group without distressed personality (low DS 14 score) with moderate aerobic exercise

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana

OTHER

Sponsor Role: collaborator

Institute for Preventive Medicine, Trzaska

OTHER

Sponsor Role: lead

Responsible Party

Mateja Hafner M.D.

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mateja Hafner, M.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Preventive medicine

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Other Identifiers

001563777

Identifier Type: -

Identifier Source: org_study_id