Adherence to an Exercise and Healthy Diet Program in Patients With Coronary
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- University Medicine Greifswald
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Feasibility of a multi-behavioral intervention program
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of the study is to implement a multimodal lifestyle intervention over 3 months in individuals ≥ 60 years of age with coronary heart disease and to examine the adherence to this intervention program. The intervention focus on three main themes: physical activity, healthy nutrition and, if necessary, smoking. The framework is formed by a psychological component: views on ageing.
Detailed Description
Long-term adherence to a healthy lifestyle that promotes heart health (e.g. physical activity, healthy diet, non-smoking) is not yet sufficiently achieved in patients with coronary artery disease (≥ 60 years). Individuals in this study will participate in a 3-month multimodal intervention program. The program includes group and individual sessions with a focus on exercise training and healthy nutrition. Positive views on ageing have been shown to be associated with a healthier lifestyle. Therefore, it seems important to consider views on ageing as part of a lifestyle intervention. The intervention program starts with a group session containing information on (i) views on ageing and its association to lifestyle and (ii) how to cope with the diagnosis of coronary heart disease in everyday life.The physical exercise training and nutrition intervention will be carried out at least twice a week for at least 60 minutes each and for a period of 3 months. During this time, participants will receive instructions to exercise regularly and adjust their nutrition according to the recommendations. The physical exercise training and nutritional recommendations should be implemented at home. Study participants who smoke tobacco will be motivated to participate in a smoking cessation program. If they are not willing to do this, short, motivating interviews on smoking cessation will be offered. A pilot study will be conducted using a pre-post design. Patients will be followed over time and data will be collected on anthropometrics, blood samples, cardiopulmonary exercise tests, and 7-day accelerometry at baseline and at 3- and 12-month follow-ups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age of ≥ 60 years
- •established CVD defined by a stenosis of ≥ 70% of a least one coronary vessel
- •optimal treatment according to the European Society of Cardiology guidelines (2016)
Exclusion Criteria
- •heart failure, left ventricular ejection fraction (LVEF) \< 40%
- •implanted cardioverter/defibrillator or pacemaker
- •recent cardiovascular event ≤ 2 months prior to study inclusion (acute myocardial infarction, resuscitation, re-vascularization, device implantation, or stroke)
- •planned coronary revascularization
- •uncontrolled blood pressure (systolic blood pressure of ≥ 200 mmHg)
- •body mass index ≥ 35 kg/m2
- •baseline cardiopulmonary exercise test results precluding safe exercise training (e.g., ischemia or arrhythmias)
- •no ability to participate in exercise training (e.g., COPD GOLD III-IV, claudication ≥ 2b, or previous disabling stroke)
- •current mental disorder requiring inpatient treatment
- •current addictions (excluding tobacco use), florid psychoses, current severe depressive episode (according to ICD-10)
Outcomes
Primary Outcomes
Feasibility of a multi-behavioral intervention program
Time Frame: Over 12 weeks (Baseline - 3-months)
Investigation on the feasibility of the 3-months multi-behavioral intervention program (exploratory); Measures: Views of participants about study quality process (semi-structured interview guide including self-developed items; qualitative and quantitative)
Adherence to a multi-behavioral intervention program
Time Frame: Over 12 weeks (Baseline - 3-months)
Investigation on (long-term) adherence to a 3-months multi-behavioral intervention program (exploratory); Measures: Documentation list of adherence to supervised physical exercise training program sessions, educational nutrition sessions, and views of ageing sessions.
Secondary Outcomes
- Cardiopulmonary exercise testing(Changes from baseline (vs. 3-months and 12-months follow-up))
- Physical behavior by accelerometry (if valid data are available)(Changes from baseline (vs. 3-months and 12-months follow-up))
- Smoking by self-report(Changes from baseline (vs. 3-months and 12-months follow-up))
- Cardiometabolic marker (II)(Changes from baseline (vs. 3-months and 12-months follow-up))
- Cardiometabolic marker (III)(Changes from baseline (vs. 3-months and 12-months follow-up))
- Views on ageing(Changes from baseline (vs. 3-months and 12-months follow-up))
- Nutrition(Changes from baseline (vs. 3-months and 12-months follow-up))
- Obesity marker(Changes from baseline (vs. 3-months and 12-months follow-up))
- Physical behavior by self-report(Changes from baseline (vs. 3-months and 12-months follow-up))
- Cardiometabolic marker (I)(Changes from baseline (vs. 3-months and 12-months follow-up))
- Brain-derived neurotrophic factor (BDNF)(Changes from baseline (vs. 3-months and 12-months follow-up))
- Blood pressure(Changes from baseline (vs. 3-months and 12-months follow-up))
- Cardiac anxiety(Changes from baseline (vs. 3-months and 12-months follow-up))