Adherence to an Exercise and Healthy Diet Program in Patients With Coronary Heart Disease Aged ≥ 60 Years

Completed

• Conditions: Adherence, Treatment; Risk Reduction Behavior; Coronary Heart Disease

• Registration Number: NCT06178263
• Lead Sponsor: University Medicine Greifswald

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.

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2023-11
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of a multi-behavioral intervention program	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	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 Outcome Measures

Name	Time	Method
Cardiopulmonary exercise testing	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in a parameter of cardiopulmonary exercise testing (VO²max); Measures: standardized measurement of cardiopulmonary exercise testing according to a modified Jones protocol; VO²max in ml O²/min/kg
Physical behavior by accelerometry (if valid data are available)	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in physical behavior; Measures: objective measurement of physical behavior by 7-day accelerometry
Smoking by self-report	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in smoking; Measures: assessement via two self-reported items
Cardiometabolic marker (II)	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in high-density lipoprotein cholesterol (in mmol/l); Measures: standardized blood sampling
Cardiometabolic marker (III)	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in glucose (in mmol/l); Measures: standardized blood sampling
Views on ageing	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in views on ageing; Measures: assessement via questionnaire (Individual views on ageing: specific (physical loss, social loss, personal growth, gains) and global)
Nutrition	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in nutrition; Measures: assessement via questionnaire (Mediterranean Diet Adherence Screener, MEDAS; doi: 10.1186/s12885-017-3337-y); 14 item, the MEDAS score can range between 0 and 14
Obesity marker	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in an abdominal obesity marker (waist circumference); Measures: standardized measurements of waist circumference in cm
Physical behavior by self-report	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in physical behavior; Measures: assessement via questionnaire (Swiss Physical Activity Questionnaire, SWISSPAQ; DOI: https://doi.org/10.4414/smw.2013.13752); questionnaire includes 19 activities and 2 open answers for activities not listed. Patients had to specify the frequency (in times per week), duration (in minutes) and intensity (Borg's subjective rating of perceived exertion) of the activities that they performed in a typical week in the previous 2 months. Metric: MET-hours.
Cardiometabolic marker (I)	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in plasma triglycerides (in mmol/l); Measures: standardized blood sampling
Brain-derived neurotrophic factor (BDNF)	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in BDNF (in ng/ml); Measures: standardized blood sampling
Blood pressure	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in blood pressure; Measures: standardized measurements of mean blood pressure (in mmHg)
Cardiac anxiety	Changes from baseline (vs. 3-months and 12-months follow-up)	Investigation on changes in cardiac anxiety; Measures: assessement via questionnaire (Cardiac Anxiety Questionnaire, CAQ; DOI: 10.1016/s0005-7967(99)00132-1); 18-item, three subscales (Fear, 8 items; Avoidance, 5 items; Attention, 5 items). Each item is rated on a 5-point Likert scale with scores ranging from 0 (never) to 4 (always). A high score indicates a greater number of symptoms, greater frequency, or both.

Trial Locations

Locations (1)

Department of Preventive Resaerch and Social Medicine, Institute for Community Medicine, University Medicine Greifswald; 🇩🇪 Greifswald, Germany