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

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ClinicalTrials.gov Identifier: NCT02493413
Recruitment Status : Completed
First Posted : July 9, 2015
Last Update Posted : July 9, 2015
Sponsor:
Collaborator:
University of Ljubljana
Information provided by (Responsible Party):
Mateja Hafner M.D., Institute for Preventive Medicine, Trzaska

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.

Condition or disease
Obesity Type D Personality Coronary Heart Disease

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Stress-release Effects of Exercise in Obese Are Determined by DS14 Score and T-cell Activation Status
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Change from Baseline in DS14 Score at 3 Months [ Time Frame: 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).

  2. Change in STAIX-1 questionnaire score [ Time Frame: 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.


  3. Change in Peripheral Human Blood Leucocytes [ Time Frame: 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.

  4. Change in Cortisol Levels [ Time Frame: 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.

  5. Change in Heart Rate variability (HRV) [ Time Frame: 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.

  6. Change in SWLS questionnaire score [ Time Frame: 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.

  7. Change in QOLLTI-P questionnaire score [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493413


Sponsors and Collaborators
Institute for Preventive Medicine, Trzaska
University of Ljubljana
Investigators
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Principal Investigator: Mateja Hafner, M.D. Institute of Preventive medicine
Publications:

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Responsible Party: Mateja Hafner M.D., M.D., Institute for Preventive Medicine, Trzaska
ClinicalTrials.gov Identifier: NCT02493413    
Other Study ID Numbers: 001563777
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015
Keywords provided by Mateja Hafner M.D., Institute for Preventive Medicine, Trzaska:
psychoneuroimmunology
stress
lymphocyte population
personality type
obesity
heart rate variability
awareness
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases