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
|Condition or disease|
|Obesity Type D Personality Coronary Heart Disease|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|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|
observational time of three months in the obese group with distressed (type D) personality (high DS 14 score) with moderate aerobic exercise
observational time of three months in obese group without distressed personality (low DS 14 score) with moderate aerobic exercise
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Principal Investigator:||Mateja Hafner, M.D.||Institute of Preventive medicine|