跳至主要内容
临床试验/NCT07729410
NCT07729410尚未招募不适用

Effects of Two-Week Eccentric Exercise-Based Cardiac Rehabilitation on Myokines, Exerkines, and Physical Function in Patients After Myocardial Infarction

Medical University of Gdansk1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Change From Baseline in Serum Musclin Concentration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Participants, care providers, and investigators are aware of group assignment. Laboratory personnel analyzing coded blood samples are blinded to treatment allocation.

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change From Baseline in Serum Musclin Concentration

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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