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临床试验/NCT03821558
NCT03821558已完成不适用

Cardiovascular Rehabilitation in Coronary Artery Disease Patients: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
1
主要终点
Change of flow-mediated dilatation of the brachial artery, measured in %

研究概览

简要总结

In this controlled trial, patients referred to post-myocardial infarction cardiac rehabilitation will be randomized to either interval or continuous training.

详细描述

The trial would i) compare the acute effects of each exercise type on selected cardiovascular indicators; ii) compare the chronic effects of each exercise type on selected cardiovascular indicators; iii) provide information on the association between acute and chronic effects of each exercise type; iv) provide insight into possible mechanisms of effectiveness of each exercise type; v) identify the most safe and effective exercise type for patients with coronary artery disease.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •myocardium infarction 120 days prior to cardiac rehabilitation

排除标准

  • •contraindications for exercise training,
  • •uncontrolled dysrhythmias,
  • •uncontrolled heart failure (New York Heart Association (NYHA) stage IV),
  • •intellectual development disorder,
  • •pregnancy.

研究组 & 干预措施

Interval training group

Active Comparator

Patients to be randomized to the 'interval training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo interval exercise series composed of high-intensity intervals (80-90% of peak exercise performance) and low-intensity intervals (60-70% of peak exercise performance).

干预措施: Exercise training (Other)

Continuous training group

Active Comparator

Patients to be randomized to the 'continuous training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo moderate continuous exercise training at 75% of peak exercise performance.

干预措施: Exercise training (Other)

结局指标

主要结局

Change of flow-mediated dilatation of the brachial artery, measured in %

时间窗: 3 months

次要结局

  • Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l(3 months)
  • Change in overall haemostatic potential(3 months)
  • Change in insuline level, measure in microIU/ml(3 months)
  • Change of the arterial stiffness coefficient(3 months)
  • Change of maximal oxygen uptake during exercise, measured in ml/kg/min(3 months)
  • Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l(3 months)
  • Change in osteopontin and D-dimer levels, measured in microg/l(3 months)
  • Change in fibrinogen and Lp(a) levels, measured in mg/dl(3 months)
  • Change in selectin and hsCRP, measured in mg/l(3 months)
  • Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l(3 months)
  • Change in copeptin levels, measured in pmol/l(3 months)
  • Change of the heart rate variability(3 months)
  • Change of the heart rate recovery(3 months)
  • Change in health-related quality of life using SF-36 questionnaire, measured in points(3 months)
  • Change in MR-proADM and MR-proANP, measured in nmol/l(3 months)
  • Change in homoarginine, ADMA and SDMA levels, measured in micromol/l(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Borut Jug

Associate Professor

University Medical Centre Ljubljana

研究点 (1)

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