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Coronary Heart DiseaseRE-Start60+NCT06178263

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

An observational study of Coronary Heart Disease and Risk Reduction Behavior, run by University Medicine Greifswald at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
How many people
37 participants
Where
1 siteGermany
Study dates
1 Dec 2017to 30 Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Preventive Resaerch and Social Medicine, Institute for Community Medicine, University Medicine Greifswald

    Greifswald, 17489

Other trials in Germany

About this study

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

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.

Read the 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.

Keywords
physical activity, nutrition, views on ageing, adherence, intervention
Medical subject headings
Coronary Disease, Risk Reduction Behavior, Treatment Adherence and Compliance, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Over 12 weeks (Baseline - 3-months)

  2. 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)

    Measured: Over 12 weeks (Baseline - 3-months)

Secondary outcomes (13)

  1. 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

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  2. Obesity marker

    Investigation on changes in an abdominal obesity marker (waist circumference); Measures: standardized measurements of waist circumference in cm

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  3. 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.

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  4. 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

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  5. Smoking by self-report

    Investigation on changes in smoking; Measures: assessement via two self-reported items

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  6. Cardiometabolic marker (I)

    Investigation on changes in plasma triglycerides (in mmol/l); Measures: standardized blood sampling

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  7. Cardiometabolic marker (II)

    Investigation on changes in high-density lipoprotein cholesterol (in mmol/l); Measures: standardized blood sampling

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  8. Cardiometabolic marker (III)

    Investigation on changes in glucose (in mmol/l); Measures: standardized blood sampling

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  9. Brain-derived neurotrophic factor (BDNF)

    Investigation on changes in BDNF (in ng/ml); Measures: standardized blood sampling

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  10. Blood pressure

    Investigation on changes in blood pressure; Measures: standardized measurements of mean blood pressure (in mmHg)

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  11. 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)

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  12. 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.

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

  13. 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

    Measured: Changes from baseline (vs. 3-months and 12-months follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2023
  2. Study start1 Dec 2017
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06178263
Sponsor's protocol ID
BB138/17
Acronym
RE-Start60+
Status last verified
Nov 2023
First submitted
30 Nov 2023
Last updated
20 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36385629

  • Ullrich A, Bahls M, Voigt L, Konemann S, Dorr M, Wurm S, Ulbricht S. A 12-week Exercise Intervention Among Older Adults With Chronic Coronary Syndrome: Changes and Associations of Movement Behaviors and Cardiovascular Risk Factors. Eur J Sport Sci. 2026 Jul;26(7):e70208. doi: 10.1002/ejsc.70208.

    PubMed 42323275

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Heart Disease and Risk Reduction Behavior, run by University Medicine Greifswald at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to a multi-behavioral intervention program (time frame: Over 12 weeks (Baseline - 3-months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06178263, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.

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