Psychodynamic Motivation and Training Program (PMT)

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Physical Activity; Coronary Heart Disease

Treatments: Behavioral: Advice in Exercise Training (+Ex); Other: Treatment as usual (TAU); Behavioral: Psychodynamic Motivation and Training Program (PMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01445808

IRB 837.274.11 (7816)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Psychodynamic Motivation and Training Program (PMT)

Experimental group

Treatment:

Behavioral: Psychodynamic Motivation and Training Program (PMT)

Advice in Exercise Training

Active Comparator group

Description:

One session of advice in exercise training based on the results of spiroergometry

Treatment:

Behavioral: Advice in Exercise Training (+Ex)

Treatment as usual (TAU)

Other group

Description:

Usual care by family doctor and cardiologist

Treatment:

Other: Treatment as usual (TAU)