Psychodynamic Motivation and Training Program

Physical Activity Clinical Trial

— PMT  

Official title:

Psychodynamic Motivation and Training Program (PMT) as Secondary Prevention in Patients With Stable Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445808
• Other study ID #: IRB 837.274.11 (7816)
• Status: Completed
• Phase: N/A
• First received: September 30, 2011
• Last updated: February 25, 2016
• Start date: October 2011
• Est. completion date: February 2015

Study information

• Verified date: February 2016
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Physical Activity

Intervention

Behavioral:
• Psychodynamic Motivation and Training Program (PMT)
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.
• Advice in Exercise Training (+Ex)
Advice in Exercise Training consists of one individual session of advice in exercise training based on the results of the spiroergometry.

Other:
• Treatment as usual (TAU)
Usual care by family doctor, cardiologist

Locations

Country	Name	City	State
Germany	University Medical Center Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in individual anaerobic threshold according to lactate kinetics during spiroergometry		6 months	No
Secondary	Change in quality of life according to the EQ-5D		6 months	No
Secondary	Change in the severity of impairment by angina symptoms according to the Seattle Angina Questionnaire		6 Months	No
Secondary	Change in the self-rated habitual physical activity according to the Habitual Physical Activity Questionnaire		6 months	No
Secondary	Change in endothelial function according to the flow mediated dilatation		6 months	No
Secondary	Change in high density lipoprotein levels		6 months	No
Secondary	Change in biomarkers of inflammation and oxidative burst		6 months	No
Secondary	Change in fatigue according to the Maastricht Questionnaire		6 months	No
Secondary	Change in illness perception	(Illness perception as measured with the Brief Illness Perception Questionnaire)	6 months	No
Secondary	Change in maximal aerobic capacity (VO2 max)		6 months	No
Secondary	Change in body mass index	(BMI kg/m²)	6 months	No