Myocardial Infarction (MI), Cardiac Rehabilitation
Conditions
Keywords
Eccentric Exercise, Eccentric Cycling, Cardiac Rehabilitation, Post-Myocardial Infarction, Myokines, Exerkines, Functional Capacity, Kinesiophobia
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.
Detailed description
Exercise-based cardiac rehabilitation is an important component of secondary prevention after myocardial infarction. However, some patients experience reduced exercise tolerance or fear of physical activity, which may limit participation in rehabilitation and contribute to physical deconditioning, loss of muscle mass, and reduced functional capacity. Eccentric exercise is characterized by muscle contractions performed while the muscle is lengthening. Compared with traditional concentric exercise, eccentric exercise can provide a relatively high mechanical load to skeletal muscles while requiring lower oxygen consumption and imposing a lower metabolic demand. For this reason, eccentric training may be a useful rehabilitation strategy for patients who have limited exercise tolerance after myocardial infarction. The intervention will consist of a two-week eccentric cycling program performed on a semi-recumbent cycle ergometer as part of comprehensive cardiac rehabilitation. The training is intended to provide controlled loading of the lower-limb muscles while limiting excessive cardiovascular strain. The primary scientific objective is to evaluate changes in the molecular response to eccentric exercise, with particular emphasis on circulating myokines and exerkines. Blood concentrations of musclin, interleukin-6, and myostatin will be assessed before and after the rehabilitation period. The study will also evaluate changes in physical performance, muscle function, and functional exercise capacity using the assessments specified in the study protocol. The findings may help determine whether eccentric exercise produces beneficial molecular and functional adaptations in patients undergoing cardiac rehabilitation after myocardial infarction.
Interventions
BEHAVIORALStandard Inpatient Cardiac Rehabilitation
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.
BEHAVIORALEccentric Cycling Exercise
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.
Sponsors
Medical University of Gdansk
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants, care providers, and investigators are aware of group assignment. Laboratory personnel analyzing coded blood samples are blinded to treatment allocation.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Any acute or uncontrolled non-cardiovascular condition that may interfere with exercise testing or worsen during exercise, including febrile illness, clinically significant electrolyte abnormalities, uncontrolled hyperthyroidism, or clinically significant anemia. * Physical or cognitive impairment preventing safe completion of the study procedures, exercise testing, or training intervention. * Inability or unwillingness to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Serum Musclin Concentration | Baseline and after completion of the 2-week inpatient cardiac rehabilitation program | 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. |
| Change From Baseline in Serum Myostatin Concentration | Baseline and after completion of the 2-week inpatient cardiac rehabilitation program | 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. |
| Change From Baseline in Serum Interleukin-6 Concentration | Baseline and after completion of the 2-week inpatient cardiac rehabilitation program | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Functional exercise capacity will be assessed using the Six-Minute Walk Test. Participants will be instructed to walk as far as possible during 6 minutes along a designated walking course under the supervision of qualified medical personnel. The total distance covered will be recorded in meters. The outcome will be calculated as the post-intervention distance minus the baseline distance, with a positive value indicating an improvement in functional exercise capacity. |
| 30-Second Chair-Stand Test | Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention | Functional lower-limb strength will be assessed using the 30-Second Chair-Stand Test. Participants will be instructed to repeatedly rise to a full standing position and return to a seated position during a 30-second period. The number of correctly completed repetitions will be recorded. The outcome will be calculated as the post-intervention number of repetitions minus the baseline number, with a positive value indicating an improvement in functional lower-limb performance. |
| 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 | Fear of physical activity and movement related to the participant's cardiac condition will be assessed using the validated Polish version of the 17-item Tampa Scale for Kinesiophobia Heart. Participants will complete the questionnaire according to the standardized scoring procedure. The total score will be reported in points. The outcome will be calculated as the post-intervention total score minus the baseline total score. A negative change will indicate a reduction in kinesiophobia, whereas a positive change will indicate an increase in kinesiophobia. |
| 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 | Maximal isometric lower-limb strength will be assessed using the Isometric Mid-Thigh Pull test performed on a force platform. Participants will perform a maximal isometric pull against a fixed bar while standing with partial flexion of the knee and hip joints. Peak force will be determined from the recorded ground reaction force signal and reported in newtons. The outcome will be calculated as the post-intervention peak force minus the baseline peak force, with a positive value indicating an increase in maximal isometric strength. |
Countries
Poland
Contacts
CONTACTJoanna Jaworska, PhD
CONTACTTomasz Klinkosz, MD
Outcome results
None listed