Clinical trial NCT02493413: The Stress-release Effects of Exercise in Obese Are Determined by DS14 Score and T-cell Activation Status
Official title: The Stress-release Effects of Exercise in Obese Are Determined by DS14 Score and T-cell Activation Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Type D Personality
Coronary Heart Disease
Keywords: psychoneuroimmunology
stress
lymphocyte population
personality type
obesity
heart rate variability
awareness
Lead sponsor: Institute for Preventive Medicine, Trzaska
Sponsor class: OTHER
Collaborators: name: University of Ljubljana
First posted: 2015-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Change from Baseline in DS14 Score at 3 Months
timeFrame: baseline and 3 months
measure: Change in STAIX-1 questionnaire score
timeFrame: baseline and 3 months
measure: Change in Peripheral Human Blood Leucocytes
timeFrame: baseline and 3 months
measure: Change in Cortisol Levels
timeFrame: baseline and 3 months
measure: Change in Heart Rate variability (HRV)
timeFrame: baseline and 3 months
measure: Change in SWLS questionnaire score
timeFrame: baseline and 3 months
measure: Change in QOLLTI-P questionnaire score
timeFrame: baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Preventive medicine
name: Mateja Hafner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Denollet J. DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med. 2005 Jan-Feb;67(1):89-97. doi: 10.1097/01.psy.0000149256.81953.49.
citation: Suwa A, Shimokawa T. Emerging targets for the treatment of obesity. FEBS J. 2011 Feb;278(4):551. doi: 10.1111/j.1742-4658.2010.07981.x. Epub 2010 Dec 30. No abstract available.
citation: Kintscher U, Hartge M, Hess K, Foryst-Ludwig A, Clemenz M, Wabitsch M, Fischer-Posovszky P, Barth TF, Dragun D, Skurk T, Hauner H, Bluher M, Unger T, Wolf AM, Knippschild U, Hombach V, Marx N. T-lymphocyte infiltration in visceral adipose tissue: a primary event in adipose tissue inflammation and the development of obesity-mediated insulin resistance. Arterioscler Thromb Vasc Biol. 2008 Jul;28(7):1304-10. doi: 10.1161/ATVBAHA.108.165100. Epub 2008 Apr 17.
citation: Ader R, Cohen N. Behaviorally conditioned immunosuppression. Psychosom Med. 1975 Jul-Aug;37(4):333-40. doi: 10.1097/00006842-197507000-00007.
citation: Thayer JF, Ahs F, Fredrikson M, Sollers JJ 3rd, Wager TD. A meta-analysis of heart rate variability and neuroimaging studies: implications for heart rate variability as a marker of stress and health. Neurosci Biobehav Rev. 2012 Feb;36(2):747-56. doi: 10.1016/j.neubiorev.2011.11.009. Epub 2011 Dec 8.
citation: Watson D, Pennebaker JW. Health complaints, stress, and distress: exploring the central role of negative affectivity. Psychol Rev. 1989 Apr;96(2):234-54. doi: 10.1037/0033-295x.96.2.234.
citation: Denollet J. Negative affectivity and repressive coping: pervasive influence on self-reported mood, health, and coronary-prone behavior. Psychosom Med. 1991 Sep-Oct;53(5):538-56. doi: 10.1097/00006842-199109000-00005.
citation: Friedman HS, Booth-Kewley S. Personality, type A behavior, and coronary heart disease: the role of emotional expression. J Pers Soc Psychol. 1987 Oct;53(4):783-92. doi: 10.1037//0022-3514.53.4.783.
citation: Gest SD. Behavioral inhibition: stability and associations with adaptation from childhood to early adulthood. J Pers Soc Psychol. 1997 Feb;72(2):467-75. doi: 10.1037//0022-3514.72.2.467.
citation: Denollet J, Sys SU, Brutsaert DL. Personality and mortality after myocardial infarction. Psychosom Med. 1995 Nov-Dec;57(6):582-91. doi: 10.1097/00006842-199511000-00011.
citation: Denollet J, Sys SU, Stroobant N, Rombouts H, Gillebert TC, Brutsaert DL. Personality as independent predictor of long-term mortality in patients with coronary heart disease. Lancet. 1996 Feb 17;347(8999):417-21. doi: 10.1016/s0140-6736(96)90007-0.
citation: Ferguson E, Ward JW, Skatova A, Cassaday HJ, Bibby PA, Lawrence C. Health specific traits beyond the Five Factor Model, cognitive processes and trait expression: replies to Watson (2012), Matthews (2012) and Haslam, Jetten, Reynolds, and Reicher (2012). Health Psychol Rev. 2013 May;7(Suppl 1):S85-S103. doi: 10.1080/17437199.2012.701061. Epub 2013 May 28.
citation: Piestrzeniewicz K, Luczak K, Lelonek M, Wranicz JK, Goch JH. Obesity and heart rate variability in men with myocardial infarction. Cardiol J. 2008;15(1):43-9.
citation: Lee DC, Pate RR, Lavie CJ, Sui X, Church TS, Blair SN. Leisure-time running reduces all-cause and cardiovascular mortality risk. J Am Coll Cardiol. 2014 Aug 5;64(5):472-81. doi: 10.1016/j.jacc.2014.04.058.
citation: Thayer JF, Sternberg E. Beyond heart rate variability: vagal regulation of allostatic systems. Ann N Y Acad Sci. 2006 Nov;1088:361-72. doi: 10.1196/annals.1366.014.
citation: Hirsch JA, Bishop B. Respiratory sinus arrhythmia in humans: how breathing pattern modulates heart rate. Am J Physiol. 1981 Oct;241(4):H620-9. doi: 10.1152/ajpheart.1981.241.4.H620.
citation: O'Keefe JH, Lavie CJ. Run for your life ... at a comfortable speed and not too far. Heart. 2013 Apr;99(8):516-9. doi: 10.1136/heartjnl-2012-302886. Epub 2012 Nov 29. No abstract available.
citation: Malfatto G, Facchini M, Sala L, Branzi G, Bragato R, Leonetti G. Effects of cardiac rehabilitation and beta-blocker therapy on heart rate variability after first acute myocardial infarction. Am J Cardiol. 1998 Apr 1;81(7):834-40. doi: 10.1016/s0002-9149(98)00021-6.
citation: Turnbull AV, Rivier C. Regulation of the HPA axis by cytokines. Brain Behav Immun. 1995 Dec;9(4):253-75. doi: 10.1006/brbi.1995.1026.
citation: Yasuma F, Hayano J. Respiratory sinus arrhythmia: why does the heartbeat synchronize with respiratory rhythm? Chest. 2004 Feb;125(2):683-90. doi: 10.1378/chest.125.2.683.
citation: Hrushesky WJ, Fader D, Schmitt O, Gilbertsen V. The respiratory sinus arrhythmia: a measure of cardiac age. Science. 1984 Jun 1;224(4652):1001-4. doi: 10.1126/science.6372092.
citation: Steptoe A, Brydon L. Emotional triggering of cardiac events. Neurosci Biobehav Rev. 2009 Feb;33(2):63-70. doi: 10.1016/j.neubiorev.2008.04.010. Epub 2008 May 3.