Psychodynamic Motivation and Training Program

Not Applicable

Completed

• Conditions: Physical Activity; Coronary Heart Disease
• Interventions: Behavioral: Advice in Exercise Training (+Ex); Behavioral: Psychodynamic Motivation and Training Program (PMT); Other: Treatment as usual (TAU)

• Registration Number: NCT01445808
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Study Timeline

• Study First Submitted: 2011-09-30
• Study First Submitted QC: 2011-09-30
• Study Start: 2011-10
• Study First Posted: 2011-10-04
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advice in Exercise Training	Advice in Exercise Training (+Ex)	One session of advice in exercise training based on the results of spiroergometry
Psychodynamic Motivation and Training Program (PMT)	Psychodynamic Motivation and Training Program (PMT)	-
Treatment as usual (TAU)	Treatment as usual (TAU)	Usual care by family doctor and cardiologist

Primary Outcome Measures

Name	Time	Method
Change in individual anaerobic threshold according to lactate kinetics during spiroergometry	6 months

Secondary Outcome Measures

Name	Time	Method
Change in illness perception	6 months	(Illness perception as measured with the Brief Illness Perception Questionnaire)
Change in maximal aerobic capacity (VO2 max)	6 months
Change in the severity of impairment by angina symptoms according to the Seattle Angina Questionnaire	6 Months
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 body mass index	6 months	(BMI kg/m²)
Change in quality of life according to the EQ-5D	6 months
Change in fatigue according to the Maastricht Questionnaire	6 months

Trial Locations

Locations (1)

University Medical Center Mainz; 🇩🇪 Mainz, Germany