Clinical trial NCT06178263: Adherence to an Exercise and Healthy Diet Program in Patients With Coronary Heart Disease Aged ≥ 60 Years
Official title: Adherence to an Exercise and Healthy Diet Program in Patients With Coronary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Risk Reduction Behavior
Adherence, Treatment
Keywords: physical activity
nutrition
views on ageing
adherence
intervention
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: German Center of Cardiovascular Diseases (DZHK)
First posted: 2023-12-20
Enrollment: 37
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients at the cardiology ward at Greifswald University Medical Center are asked to take part in the lifestyle intervention study. Eligible patients aged ≥ 60 years will be invited to participate in the study by mail. In order to be included as a study participant, written informed consent is required.

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.

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)
* severe cognitive or physical impairment
* no serious co-existing diseases (e.g., cancer) with life expectancy \< 1 year
* weekly self-reported PA ≥ 150 minutes on a moderate intensity level ≤ 6 months prior to study inclusion

Primary outcomes:
measure: Adherence to a multi-behavioral intervention program
timeFrame: Over 12 weeks (Baseline - 3-months)
measure: Feasibility of a multi-behavioral intervention program
timeFrame: Over 12 weeks (Baseline - 3-months)
Secondary outcomes:
measure: Cardiopulmonary exercise testing
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Obesity marker
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Physical behavior by self-report
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Physical behavior by accelerometry (if valid data are available)
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Smoking by self-report
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Cardiometabolic marker (I)
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Cardiometabolic marker (II)
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Cardiometabolic marker (III)
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Brain-derived neurotrophic factor (BDNF)
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Blood pressure
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Views on ageing
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Cardiac anxiety
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
measure: Nutrition
timeFrame: Changes from baseline (vs. 3-months and 12-months follow-up)
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Department of Preventive Resaerch and Social Medicine, Institute for Community Medicine, University Medicine Greifswald
Study officials:
affiliation: Department of Preventive Research and Social Medicine, University Medicine Greifswald
name: Sabina Ulbricht, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Ullrich A, Wenzel K, Bahls M, Voigt L, Konemann S, Dorr M, Wurm S, Ulbricht S. Preliminary results of the cross-sectional associations of sedentary behavior and physical activity with serum brain-derived neurotrophic factor in adults with coronary heart disease. Sci Rep. 2022 Nov 16;12(1):19685. doi: 10.1038/s41598-022-23706-8.