Eccentric Exercise Rehabilitation After Myocardial Infarction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-75
SponsorMedical University of Gdansk
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Inpatient Cardiac Rehabilitation
BehavioralStandard 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.
Eccentric Cycling Exercise
BehavioralSupervised 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Standard Cardiac RehabilitationActive comparator 1 intervention
Group B: Standard Cardiac Rehabilitation Plus Eccentric CyclingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and after completion of the 2-week inpatient cardiac rehabilitation program2
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.
Time frame
Baseline and after completion of the 2-week inpatient cardiac rehabilitation program3
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.
Time frame
Baseline and after completion of the 2-week inpatient cardiac rehabilitation programSecondary outcomes
1
Change From Baseline in Six-Minute Walk Distance
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.
Time frame
Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention2
30-Second Chair-Stand Test
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.
Time frame
Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention3
Change From Baseline in Kinesiophobia Assessed Using the Tampa Scale for Kinesiophobia Heart
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.
Time frame
Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week intervention4
Change From Baseline in Peak Force During the Isometric Mid-Thigh Pull Test
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.
Time frame
Baseline, before initiation of the inpatient cardiac rehabilitation program, and after completion of the 2-week interventionOther outcomes
1
Change From Baseline in the Kynurenine-to-Tryptophan Ratio
Plasma kynurenine concentration will be measured in fasting venous blood samples using a validated analytical method. The outcome will be calculated as the concentration measured after completion of the intervention minus the baseline concentration.
Time frame
Baseline, before initiation of stage I inpatient cardiac rehabilitation, and after completion of the 2-week interventionSponsors and contacts
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Source ClinicalTrials.gov
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