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

NCT02493413 | Completed DMC

• 1 other identifier: 001563777
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Type D Personality; Coronary Heart Disease

Keywords

psychoneuroimmunology; stress; lymphocyte population; personality type; obesity; heart rate variability; awareness

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• obese people without detectable complications of coronary heart disease

You may not qualify if:

• Obese patients with angina pectoris, myocardial infarction, valvular heart disease and congestive heart disease had been excluded from the research.

Sponsors & Collaborators

• Institute for Preventive Medicine, Trzaska: lead
• University of Ljubljana: collaborator

Related Publications (22)

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MeSH Terms

Conditions

Obesity; Coronary Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Mateja Hafner, M.D.

  Institute of Preventive medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 9, 2015
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: July 9, 2015

Record last verified: 2015-07