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临床试验/NCT02916225
NCT02916225已完成不适用

High Intensity Interval Training Versus Moderate Continuous Training in Heart Failure With Preserved Ejection Fraction Patients: a Randomized Study.

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2014年6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
19
试验地点
1
主要终点
Maximal Oxygen Consumption

研究概览

简要总结

The purpose of this study is to determine whether high intensity interval training (HIIT) is superior to moderate continuous training in increasing cardiopulmonary capacity in heart failure with preserved ejection fraction patients.

详细描述

High intensity interval training (HIIT) has been proved to increase oxygen consumption, having superior cardiovascular effect when compared to moderate continuous training (MCT) in post-infarction patients (Wisloff et al.) Aerobic training also had shown positive effect on oxygen consumption and diastolic function in subjects with HFPEF when compared to usual care (Edelmann et al).

However, the comparison of HIIT and MCT on improving functional capacity and diastolic function in HFPEF patients has not yet been study.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Patients with heart failure with preserved ejection fraction (HFPEF) of any etiology that have functional class of the New York Heart Association (NYHA) between I and III, left ventricular ejection fraction > 50% and who meet clinical and echocardiography criteria for HFPEF according to the consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology (Paulus et al.). Patients should be clinical stable for the last 3 months and under optimized pharmacologic treatment, being capable of walking without limitations.

排除标准

  • •Patients with exercise-induced unstable ventricular arrhythmias, unstable angina, moderate to severe valvular heart disease, severe pulmonary disease, severe anemia, cognitive limitations to understand study protocol, use of pacemaker, autonomic neuropathy, cardiovascular event for less than 3 months, congenital heart disease, terminal illness with less than 1 year of life expectancy, peripheral arterial disease with intermittent claudication or osteoarticular conditions limiting exercise will be excluded.

研究组 & 干预措施

High intensity interval training

Active Comparator

exercise protocol for high intensity/aerobic interval training as described by ESC statement (Mezzani et al.)

干预措施: High Intensity Interval Training (Behavioral)

Moderate Continuous Training

Placebo Comparator

exercise protocol for continuous aerobic training as described by ESC statement (Mezzani et al.)

干预措施: Moderate Continuous Training (Behavioral)

结局指标

主要结局

Maximal Oxygen Consumption

时间窗: 12 weeks after beginning of training

次要结局

  • Diastolic Function(12 weeks after beginning of training)
  • Pulmonary function tests(12 weeks after beginning of training)
  • Respiratory muscle strength(12 weeks after beginning of training)
  • Quality of life(12 weeks after beginning of training)

研究者

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

Ricardo Stein

Assistant Professor

Hospital de Clinicas de Porto Alegre

研究点 (1)

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