Clinical trial NCT01445808: Psychodynamic Motivation and Training Program
Official title: Psychodynamic Motivation and Training Program (PMT) as Secondary Prevention in Patients With Stable Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Physical Activity
Keywords: psychodynamic psychotherapy
coronary heart disease
physical activity
secondary prevention
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2011-10-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Stable coronary heart disease with CCS functional classification of angina class I-III
* Low self rated physical activity
* Condition after percutaneous coronary intervention \> 4 weeks until \< 26 weeks or \> 52 weeks after index percutaneous coronary intervention
* Residence \< 50 km radius of Mainz
* If treatment with betablockers or ivabradine then stable \> 4 weeks

Exclusion Criteria:

* Acute coronary sydnrome or myocardial infarction \< 8 weeks
* Coronary stenosis of the dominant vessel \> 25% or high grade stenosis of the left coronary artery
* Heart failure with left ventricular ejection fraction \< 40%
* NYHA III-IV
* Severe heart valve disorder
* Insulin dependent diabetes
* Orthopedic disorders or other disorders, which preclude regular physical activity
* Coronary artery bypass surgery \< 6 months before index PCI
* Severe obesity (BMI ≥ 40)
* Need for systemic immunosuppression with cortisone or methotrexate
* Kidney failure with need for dialysis
* Intake of nitrates \< 12 hours

Primary outcomes:
measure: Change in individual anaerobic threshold according to lactate kinetics during spiroergometry
timeFrame: 6 months
Secondary outcomes:
measure: Change in quality of life according to the EQ-5D
timeFrame: 6 months
measure: Change in the severity of impairment by angina symptoms according to the Seattle Angina Questionnaire
timeFrame: 6 Months
measure: Change in the self-rated habitual physical activity according to the Habitual Physical Activity Questionnaire
timeFrame: 6 months
measure: Change in endothelial function according to the flow mediated dilatation
timeFrame: 6 months
measure: Change in high density lipoprotein levels
timeFrame: 6 months
measure: Change in biomarkers of inflammation and oxidative burst
timeFrame: 6 months
measure: Change in fatigue according to the Maastricht Questionnaire
timeFrame: 6 months
measure: Change in illness perception
timeFrame: 6 months
measure: Change in maximal aerobic capacity (VO2 max)
timeFrame: 6 months
measure: Change in body mass index
timeFrame: 6 months
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center Mainz
Study officials:
affiliation: University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy
name: Matthias Michal, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.