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临床试验/NCT04248894
NCT04248894Unknown不适用

The Impact of High-intensity Interval Training Versus Moderate Continuous Training on Neurovascular Control in Patients With Heart Failure

University of Sao Paulo General Hospital3 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
35
试验地点
3
主要终点
Change muscle mechanoreceptor sensitivity

研究概览

简要总结

In this study, the investigators are testing the hypothesis that reduction in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (HFrEF).

详细描述

In this study, the investigators are testing the hypothesis that reductions in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (HFrEF). To test this hypothesis patients with chronic heart failure (30 - 65 years), left ventricular ejection fraction ≤40%, Functional Classes II-III), are being randomized into exercise with HIIT, MICT or no training (NT) three times/week for 12 weeks. Muscle sympathetic nerve activity is assessed by microneurography. Brachial artery flow-mediated dilation (FMD), blood flow and vascular conductance were assessed by ultrasonography. Blood pressure (BP) and heart rate (HR) by are being measured via finger photoplethysmograph and peak oxygen uptake (V̇O2peak) by a cardiopulmonary exercise test on ergometer cycle for leg. Biopsy samples from the lateral vast of the thigh are being collected for analysis of the intracellular mechanisms in the skeletal muscle. Exercise training is being conducted under supervision at the Heart Institute, School of Medicine, University of São Paulo. Both HIIT and MICT are performed on a cycle ergometer, three times per week for 12 weeks, and training sessions were matched for energy expenditure (i.e., an isocaloric energy expenditure of 200 Kcal/session). The intensity of the MICT session is established based on the HR and workload levels corresponding to anaerobic threshold and respiratory compensation point (RCP). The intensity of the HIIT session is established based on the HR and workload levels corresponding to 5% above the RCP. All exercise sessions were performed under the supervision of an exercise physiologist. The patients in the NT group were instructed to avoid any regular exercise program or any non-supervised exercise protocol during the study. All patients are being assessed before (pre) and after (post) both exercise training modes or control, no training.

研究设计

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

入排标准

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

入选标准

  • Functional Class II to III of New York Heart Association
  • Left ventricular ejection fraction ≤40%
  • Peak oxygen uptake (V̇O2) <20 ml•kg-1•min-1

排除标准

  • Myocardial infarction within three months
  • Unstable angina
  • Acute heart failure
  • Pacemaker
  • Pulmonary disease
  • Chronic renal disease
  • Peripheral neuropathy
  • History of stroke
  • Untreated hypo/hyperthyroidism
  • Body mass index (BMI) >30 kg/m2
  • History of smoking

结局指标

主要结局

Change muscle mechanoreceptor sensitivity

时间窗: Baseline and 12 weeks

The mechanoreceptor sensitivity is being assessed via passive exercise to the leg

Change in muscle sympathetic nerve activity (MSNA)

时间窗: Baseline and 12 weeks

MSNA is being assessed by microneurography

Change in chemoreceptor sensitivity

时间窗: Baseline and 12 weeks

Hypoxia via 10% oxygen

Change muscle metaboreceptor sensitivity

时间窗: Baseline and 12 weeks

The metaboreceptor sensitivity is being assessed via dynamic exercise to the leg.The exercise intensity is 30% maximum voluntary contraction.

次要结局

  • Peripheral vascular function(Baseline and 12 weeks)
  • Skeletal muscle function(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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