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

NCT06178263 | Completed

• 1 other identifier: BB138/17
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Risk Reduction Behavior; Adherence, Treatment

Keywords

physical activity; nutrition; views on ageing; adherence; intervention

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (13)

• Cardiopulmonary exercise testing

  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)

• 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)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• heart failure, left ventricular ejection fraction (LVEF) \< 40%
• implanted cardioverter/defibrillator or pacemaker
• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead
• German Center of Cardiovascular Diseases (DZHK): collaborator

Study Sites (1)

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

Greifswald, 17489, Germany

Location

Related 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 disease. Sci Rep. 2022 Nov 16;12(1):19685. doi: 10.1038/s41598-022-23706-8.

  PMID: 36385629 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Coronary Disease; Risk Reduction Behavior; Treatment Adherence and Compliance; Motor Activity

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior; Health Behavior

Study Officials

• Sabina Ulbricht, Prof. Dr.

  Department of Preventive Research and Social Medicine, University Medicine Greifswald

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 20, 2023
• Study Start: December 1, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: December 20, 2023

Record last verified: 2023-11

Locations

DE (1)