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

Coronary Heart Disease Clinical Trial

— RE-Start60+  

Official title:

Adherence to an Exercise and Healthy Diet Program in Patients With Coronary

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06178263
• Other study ID #: BB138/17
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2023
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Treatment
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Risk Reduction Behavior

Locations

Country	Name	City	State
Germany	Department of Preventive Resaerch and Social Medicine, Institute for Community Medicine, University Medicine Greifswald	Greifswald

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	German Center of Cardiovascular Diseases (DZHK)

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to a multi-behavioral intervention program	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.	Over 12 weeks (Baseline - 3-months)
Primary	Feasibility of a multi-behavioral intervention program	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)	Over 12 weeks (Baseline - 3-months)
Secondary	Cardiopulmonary exercise testing	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	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Obesity marker	Investigation on changes in an abdominal obesity marker (waist circumference); Measures: standardized measurements of waist circumference in cm	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Physical behavior by self-report	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.	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Physical behavior by accelerometry (if valid data are available)	Investigation on changes in physical behavior; Measures: objective measurement of physical behavior by 7-day accelerometry	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Smoking by self-report	Investigation on changes in smoking; Measures: assessement via two self-reported items	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Cardiometabolic marker (I)	Investigation on changes in plasma triglycerides (in mmol/l); Measures: standardized blood sampling	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Cardiometabolic marker (II)	Investigation on changes in high-density lipoprotein cholesterol (in mmol/l); Measures: standardized blood sampling	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Cardiometabolic marker (III)	Investigation on changes in glucose (in mmol/l); Measures: standardized blood sampling	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Brain-derived neurotrophic factor (BDNF)	Investigation on changes in BDNF (in ng/ml); Measures: standardized blood sampling	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Blood pressure	Investigation on changes in blood pressure; Measures: standardized measurements of mean blood pressure (in mmHg)	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Views on ageing	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)	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Cardiac anxiety	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.	Changes from baseline (vs. 3-months and 12-months follow-up)
Secondary	Nutrition	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	Changes from baseline (vs. 3-months and 12-months follow-up)