Eccentric Exercise Rehabilitation After Myocardial Infarction

NCT07729410 | Not Yet Recruiting

• 2 other identifiers: GUMED-ECC-MI-001KB/359/2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will evaluate a two-week eccentric exercise program conducted as part of comprehensive cardiac rehabilitation in patients after a heart attack (myocardial infarction). Eccentric exercise involves muscle contractions while the muscles are lengthening and may allow the muscles to work at a relatively high load with a lower cardiovascular and metabolic demand than traditional exercise. The main aim of the study is to determine whether eccentric exercise affects blood levels of proteins released or regulated in response to physical activity, including musclin, interleukin-6, and myostatin. The study will also evaluate whether the program improves physical performance and functional capacity. Participants will complete eccentric cycling exercise on a semi-recumbent cycle ergometer during a two-week cardiac rehabilitation program. Blood samples and physical-function measurements will be collected before and after the intervention.

Conditions

Cardiac Rehabilitation; Myocardial Infarction (MI)

Keywords

Eccentric Exercise; Eccentric Cycling; Cardiac Rehabilitation; Post-Myocardial Infarction; Myokines; Exerkines; Functional Capacity; Kinesiophobia

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Serum Musclin Concentration

  Serum musclin concentration will be measured in fasting venous blood samples using an enzyme-linked immunosorbent assay (ELISA). The outcome will be calculated as the concentration measured after the intervention minus the baseline concentration and reported in ng/mL.

  Baseline and after completion of the 2-week inpatient cardiac rehabilitation program

• Change From Baseline in Serum Myostatin Concentration

  Serum myostatin concentration will be measured in fasting venous blood samples using an enzyme-linked immunosorbent assay (ELISA). The outcome will be calculated as the concentration measured after the intervention minus the baseline concentration.

  Baseline and after completion of the 2-week inpatient cardiac rehabilitation program

• Change From Baseline in Serum Interleukin-6 Concentration

  Serum interleukin-6 concentration will be measured in fasting venous blood samples using an enzyme-linked immunosorbent assay (ELISA). The outcome will be calculated as the concentration measured after the intervention minus the baseline concentration.

  Baseline and after completion of the 2-week inpatient cardiac rehabilitation program

Secondary Outcomes (4)

• Change From Baseline in Six-Minute Walk Distance

  Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention

• 30-Second Chair-Stand Test

  Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention

• Change From Baseline in Kinesiophobia Assessed Using the Tampa Scale for Kinesiophobia Heart

  Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention

• Change From Baseline in Peak Force During the Isometric Mid-Thigh Pull Test

  Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention

Other Outcomes (1)

• Change From Baseline in the Kynurenine-to-Tryptophan Ratio

  Baseline, before initiation of stage I inpatient cardiac rehabilitation, and after completion of the 2-week intervention

Study Arms (2)

Standard Cardiac Rehabilitation

ACTIVE COMPARATOR

Standard stage I inpatient cardiac rehabilitation provided after myocardial infarction and individualized according to each participant's clinical condition and exercise capacity. The program includes standard kinesitherapy and exercise-based rehabilitation procedures.

Behavioral: Standard Inpatient Cardiac Rehabilitation

Standard Cardiac Rehabilitation Plus Eccentric Cycling

EXPERIMENTAL

Supervised eccentric cycling exercise performed on a motor-driven semi-recumbent cycle ergometer in addition to standard inpatient cardiac rehabilitation. Sessions will last 10 to 30 minutes, with progressive adaptation during the first five sessions. Exercise workload will be individualized according to baseline exercise capacity. Perceived exertion and muscle soreness will be monitored during each session.

Behavioral: Standard Inpatient Cardiac Rehabilitation; Behavioral: Eccentric Cycling Exercise

Interventions

Standard Inpatient Cardiac Rehabilitation BEHAVIORAL

Standard stage I inpatient cardiac rehabilitation provided after myocardial infarction and individualized according to each participant's clinical condition and exercise capacity. The program includes standard kinesitherapy and exercise-based rehabilitation procedures.

Standard Cardiac Rehabilitation; Standard Cardiac Rehabilitation Plus Eccentric Cycling

Eccentric Cycling Exercise BEHAVIORAL

Supervised eccentric cycling exercise performed on a motor-driven semi-recumbent cycle ergometer in addition to standard inpatient cardiac rehabilitation. Sessions will last 10 to 30 minutes, with progressive adaptation during the first five sessions. Exercise workload will be individualized according to baseline exercise capacity. Perceived exertion and muscle soreness will be monitored during each session.

Standard Cardiac Rehabilitation Plus Eccentric Cycling

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented history of myocardial infarction confirmed by medical records.
• Qualification for stage I comprehensive inpatient cardiac rehabilitation.
• Clinically stable condition allowing participation in exercise-based cardiac rehabilitation.
• New York Heart Association functional class I or II.
• Moderate or good exercise tolerance, defined as an exercise capacity of at least 5 metabolic equivalents, assessed during an exercise test.
• No cardiovascular contraindications to exercise testing or participation in exercise-based cardiac rehabilitation.
• Ability to understand the study procedures and follow the instructions provided by the study personnel.
• Provision of written informed consent to participate in the study.

You may not qualify if:

• Any contraindication to exercise-based cardiac rehabilitation or exercise testing.
• Acute myocardial infarction within the first 4 days before planned initiation of exercise rehabilitation.
• Unstable angina.
• Significant left main coronary artery stenosis considered a contraindication to exercise by the treating cardiologist.
• Symptomatic cardiac arrhythmias.
• Symptomatic severe aortic stenosis.
• Decompensated heart failure.
• Acute pulmonary embolism or pulmonary infarction.
• Deep vein thrombosis.
• Recent or mobile intracardiac thrombus.
• Acute myocarditis, endocarditis, or pericarditis.
• Aortic dissection.
• Symptomatic acquired second- or third-degree atrioventricular block without appropriate cardiac pacing.
• Poorly controlled arterial hypertension.
• Recent stroke or transient cerebral ischemic event.

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Florian Ceynowa Specialist Hospital in Wejherowo

Wejherowo, Pomeranian Voivodeship, 84-200, Poland

Location

MeSH Terms

Conditions

Myocardial Infarction; Kinesiophobia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Joanna Jaworska, PhD

CONTACT

+48503864566; joanna.jaworska@awf.gda.pl

Tomasz Klinkosz, MD

CONTACT

+48729716689; tomaszklinkosz12@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants, care providers, and investigators are aware of group assignment. Laboratory personnel analyzing coded blood samples are blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, controlled, two-arm parallel-group study comparing standard inpatient cardiac rehabilitation with the same rehabilitation program supplemented by eccentric cycling exercise in patients after myocardial infarction.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: July 22, 2026
• Primary Completion (Estimated): July 21, 2027
• Study Completion (Estimated): July 21, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)