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Clinical Trials/NCT07624240
NCT07624240CompletedNot Applicable

Educational Dietary Intervention in Early Cardiac Rehabilitation After Myocardial Infarction

Medical University of Lublin1 site in 1 country50 target enrollmentStarted: June 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joanna Popiołek-Kalisz

Associate Professor

Medical University of Lublin

Study Sites (1)

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