Educational Dietary Intervention in Early Cardiac Rehabilitation After Myocardial Infarction

NCT07624240 | Completed

• 1 other identifier: KE-0254/86/05/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is designed to assess whether individualized nutritional education provides additional benefit beyond standard early cardiac rehabilitation in patients after myocardial infarction. Patients referred for cardiac rehabilitation after myocardial infarction are randomized to a control group receiving standard rehabilitation care or to an intervention group receiving standard care plus structured personalized dietary education. The educational intervention is tailored to baseline dietary habits, nutritional knowledge, and adherence to cardioprotective dietary recommendations. Outcomes include changes in diet quality, adherence to the Mediterranean diet, nutritional knowledge, anthropometric measures, and bioelectrical impedance analysis-derived body composition parameters. The study will evaluate the feasibility and effectiveness of integrating individualized dietary education into early cardiac rehabilitation after myocardial infarction.

Conditions

Myocardial Infarction; Cardiac Rehabilitation

Keywords

myocardial infarction; cardiac rehabiltiation; dietary edutation

Outcome Measures

Primary Outcomes (4)

• Diet quality

  Overall diet quality assessed with Diet Quality Index score derived from Dietary Habits and Nutrition Beliefs Questionnaire

  3 months

• Dietary knowledge

  Diet knowledge score derived from Dietary Habits and Nutrition Beliefs Questionnaire

  3 months

• Body mass

  3 months

• Fat mass

  3 months

Study Arms (2)

Additional education

EXPERIMENTAL

Behavioral: Dietary education

Standard of care

NO INTERVENTION

Interventions

Dietary education BEHAVIORAL

Participants in the intervention group receive standard early cardiac rehabilitation supplemented with individualized dietary counselling provided by a trained dietitian. The counselling is tailored to baseline dietary habits, nutritional knowledge, cardiovascular risk factors, nutritional status, comorbidities, and body composition. The intervention focuses on improving adherence to cardioprotective and Mediterranean-style dietary recommendations, including higher intake of vegetables, fruit, whole-grain products, legumes, nuts, fish, and unsaturated fats, and reduced intake of saturated fats, highly processed foods, sweets, sugar-sweetened beverages, and excess salt. The intervention includes assessment of current diet, identification of key dietary errors, practical recommendations, and individualized nutrition-related goals during cardiac rehabilitation.

Additional education

Eligibility Criteria

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

You may qualify if:

• age ≥18 years,
• recent myocardial infarction treated according to standard clinical practice,
• qualification for early cardiac rehabilitation after myocardial infarction,
• clinically stable status at enrollment,
• ability to participate in standard rehabilitation and additional nutritional education,
• ability to complete dietary and nutritional knowledge questionnaires,
• ability to undergo anthropometric measurements and bioelectrical impedance analysis,
• provision of written informed consent.

You may not qualify if:

• refusal or inability to provide informed consent,
• contraindications to cardiac rehabilitation,
• severe clinical instability, including unstable hemodynamic status, recurrent ischemia, uncontrolled arrhythmia, or decompensated heart failure, preventing participation in rehabilitation;
• severe cognitive, psychiatric, or communication limitations preventing participation in educational sessions or reliable questionnaire completion,
• conditions preventing valid body composition assessment (according to device producer e.g. large metal implants).

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Medical University of Lublin

Lublin, 20-093, Poland

Location

Related Publications (2)

• Popiolek-Kalisz J, Mazur M, Perone F. The Role of Dietary Education in Cardiac Rehabilitation. Nutrients. 2025 Mar 19;17(6):1082. doi: 10.3390/nu17061082.

  PMID: 40292477 BACKGROUND

• Popiolek-Kalisz J. The role of nutrition in cardiovascular protection - personalized versus universal dietary strategies. Trends Cardiovasc Med. 2026 Feb;36(2):84-90. doi: 10.1016/j.tcm.2025.08.007. Epub 2025 Aug 22.

  PMID: 40850360 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

PL (1)