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The purpose of this study is to examine the effectiveness of a Psychodynamic Motivation and Training Program (PMT) for the improvement of physical fitness in patients with stable coronary heart disease as compared to advice in exercise training or treatment as usual.
Nonpharmacological secondary prevention of coronary heart disease is considered to be a safe and effective measure for reducing mortality substantially. Major targets are the improvement of physical activity and dietary habits, smoking cessation and stress reduction. Despite the effectiveness of life style changes, the compliance rate of patients is very low. To improve compliance with life style change programs psychotherapeutic interventions appear to have significant potential. Against this background our study aims to examine the effectiveness of a Psychodynamic Motivation and Training Program (PMT) in addition to one session of advice in exercise training based on the results of spiroergometry (+EX) and usual cardiological care (TAU). PMT will be compared with +Ex and TAU. N = 90 patients with stable coronary artery disease class, low physical activity, class I to III angina pectoris will be randomly assigned to the three treatment conditions. The Primary efficacy endpoint is change in the anaerobic threshold from baseline to 6 month follow-up. The results of the study will 1) help to determine the effectiveness of a psychodynamic life style change programs for the secondary prevention of cardiovascular disease and 2) will help to identify measures for designing specifically tailored interventions to improve compliance with cardiovascular prevention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychodynamic Motivation and Training Program (PMT) | Experimental |
| |
| Advice in Exercise Training | Active Comparator | One session of advice in exercise training based on the results of spiroergometry |
|
| Treatment as usual (TAU) | Other | Usual care by family doctor and cardiologist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychodynamic Motivation and Training Program (PMT) | Behavioral | The Psychodynamic Motivation and Training Program (PMT) is a psychodynamic stepped care approach. Depending on the individual needs PMT consists of 3 to 8 sessions of individual psychodynamic psychotherapy. If appropriate session 4 - 8 may be conducted by a nurse. PMT targets the mental and external barriers to improve physical activity by focusing on affects, interpersonal relations and maladaptive self- and other representations. PMT will be offered in addition to +Ex. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in individual anaerobic threshold according to lactate kinetics during spiroergometry | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life according to the EQ-5D | 6 months | |
| Change in the severity of impairment by angina symptoms according to the Seattle Angina Questionnaire | 6 Months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Michal, PD Dr. med. | University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Mainz | Mainz | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24066805 | Derived | Michal M, Simon P, Gori T, Konig J, Wild PS, Wiltink J, Tug S, Sterzing B, Unterrainer J, Munzel T, Beutel ME. Psychodynamic Motivation and Training program (PMT) for the secondary prevention in patients with stable coronary heart disease: study protocol for a randomized controlled trial of feasibility and effects. Trials. 2013 Sep 25;14:314. doi: 10.1186/1745-6215-14-314. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D015444 | Exercise |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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|
| Advice in Exercise Training (+Ex) | Behavioral | Advice in Exercise Training consists of one individual session of advice in exercise training based on the results of the spiroergometry. |
|
| Treatment as usual (TAU) | Other | Usual care by family doctor, cardiologist |
|
| Change in the self-rated habitual physical activity according to the Habitual Physical Activity Questionnaire |
| 6 months |
| Change in endothelial function according to the flow mediated dilatation | 6 months |
| Change in high density lipoprotein levels | 6 months |
| Change in biomarkers of inflammation and oxidative burst | 6 months |
| Change in fatigue according to the Maastricht Questionnaire | 6 months |
| Change in illness perception | (Illness perception as measured with the Brief Illness Perception Questionnaire) | 6 months |
| Change in maximal aerobic capacity (VO2 max) | 6 months |
| Change in body mass index | (BMI kg/m²) | 6 months |
| D001519 |
| Behavior |
| D005159 | Health Care Facilities Workforce and Services |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |