Effects of ACE Genotype on Muscular and Functional Adaptations Following a Cardiovascular Rehabilitation Program

Balgrist University Hospital4 个研究点分布在 1 个国家目标入组 60 人开始时间: 2016年5月1日最近更新: 2023年8月16日

适应症

试验速览

阶段: 2 期
状态: 终止
发起方
入组人数: 60
试验地点: 4
主要终点: Molecular muscle characteristics - mRNA

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study aims to systematically investigate the interaction between training modality, ACE genotype and disease in heart patients whom complete a cardiovascular rehabilitation program. This is carried out with the goal to improve the benefit of cardiovascular rehabilitation for the patient by maximising adjustments in muscle structure and function with the intervention. A population of healthy individuals will be recruited who will carry out the same training program, in order to compare the training effects respective to the general population.

详细描述

Pharmacological inhibition of angiotensin converting enzyme modifies exercise-induced pro-angiogenic and mitochondrial gene transcript expression. Exercise-induced muscle plasticity importantly interacts with the insertion/deletion genotype of ACE and the training modality and intensity. The aim of this study is to systematically investigate the interaction between training modality, ACE genotype and disease in heart patients whom complete a cardiovascular rehabilitation program.

There are two training modalities being used: The first modality involves cardiovascular training by an interval type of protocol that includes a high repetition number of shortening (i.e. concentric) type contractions on a softrobotic device. The second modality includes a high repetition number of lengthening (i.e. eccentric) type contractions on a softrobotic device. In both training modalities the same muscle groups are exercised over the same range of motion, with the same speed of movement, but with widely differing pedal force. Total absolute external mechanical work will be matched.

In order to assess the baseline values and the effect size of the muscle and training adjustments made, healthy male and female volunteers will be included who are matched with respect to age and sex to the patient population and undergo the same training program.

研究设计

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

入排标准

年龄范围: 20 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Patient group inclusion criteria:
•stable coronary heart patients/heart patients without ischemia
•Left ventricular ejection fraction > 50%
•Drug therapy with ACE inhibitors
•V̇O2peak <86% of the medical reference value Voluntary participation
•Written informed consent of the subject to participate in the study

排除标准

•relevant valvular heart disease
•arterial hypertension (blood pressure at rest> 140/90)
•arrhythmogenic cardiomyopathy
•ACE inhibitor intolerance
•contraindication for ethical reasons
•known or suspected non-compliance with the curriculum
•drug or alcohol disease
•inability of the patient to follow the study procedures (e.g. because of language problems, mental illness, dementia)
•participation in another clinical trial within the last 30 days prior to confinement and during the study
•other, clinically significant comorbidities (cardiac arrhythmia, renal insufficiency, hepatic dysfunction, connective tissue disease [Marfan syndrome, Ehlers-Danlos syndrome])
•Healthy subject group inclusion criteria:
•inconspicuous ECG under exercise (persons in whom the exercise ECG is abnormal will be referred for a cardiological evaluation recessed to the University Hospital Zurich)
•V̇O2peak <50 ml O2 min-1 kg-1
•Voluntary participation
•Written informed consent of the subject to participate in the study
•exclusion criteria:
•relevant valvular heart disease
•arterial hypertension (blood pressure at rest> 140/90)
•arrhythmogenic cardiomyopathy
•ACE inhibitor intolerance
•contraindication for ethical reasons
•known or suspected non-compliance with the curriculum
•drug or alcohol disease
•inability of the patient to follow the study procedures (e.g. because of language problems, mental illness, dementia)
•participation in another clinical trial within the last 30 days prior to confinement and during the study
•other, clinically significant comorbidities (cardiac arrhythmia, renal insufficiency, hepatic dysfunction, connective tissue disease [Marfan syndrome, Ehlers-Danlos syndrome])