跳至主要内容
临床试验/NCT05354271
NCT05354271Unknown不适用

Impact of High-intensity Interval Training in Patients With Atrial Fibrillation: Understanding of the Underlying Cardiovascular Mechanisms

Liverpool John Moores University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年8月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Change in burden of atrial fibrillation

研究概览

简要总结

A key characteristic of the heart is its regular rhythm. When the heart is exposed to irregular electric impulses, such as with atrial fibrillation (AF), detrimental effects can occur affecting the ability of the heart to pump blood. AF affects more than 33 million individuals worldwide, and places individuals at increased risk for stroke, heart failure and death. Of note, being fit seems to protect the long-term severity of AF, and individuals with AF who improved their aerobic fitness seem to decrease their severity of atrial fibrillation. Although exercise training is known to improve aerobic fitness, there are limited data investigating the benefits of an exercise training program on the reduction of AF burden.

Once AF is present, regular exercise in these patients reduces the risk for developing cardiovascular events. Moreover, exercise training at high-intensity seems to bring greater adaptations in cardiac patients. This effect may be related to improvements in cardiovascular function and structure. No previous study has explored this possibility in patients with AF. Therefore, I will assess cardiac function and blood vessel quality before and after exercise training (at high- and moderate-intensities) in patients with AF. Better insight into how intensity of exercise training could affect the heart and the blood vessels can lead to better exercise recommendations in this population.

This project will contribute to improved clinical care for patients with AF, specifically related to the prescription of the optimal dose and type of exercise. This may result in fewer complications, improved quality of life, and lower socio-economic/healthcare costs.

详细描述

Atrial fibrillation (AF) is the most common clinically significant arrhythmia, affecting more than 33 million individuals worldwide. AF leads to structural and electrical remodeling in both the atria and ventricles and is strongly related to an increased risk of stroke, heart failure and death. The CARDIO-FIT study demonstrated that AF patients with a higher baseline aerobic fitness were almost 3 times more likely to maintain arrhythmia freedom after a 4-year follow-up; also, AF patients who gained more than 2 metabolic equivalents (METs, aerobic fitness) were more than two-fold more likely to maintain sinus rhythm.

High-intensity exercise training and atrial fibrillation. Each METs gained was associated with a 9% decline in the risk of arrhythmia recurrence. From studies performed in patients with cardiovascular disease, high-intensity interval training (HIIT) seems to bring at least similar or greater improvements in aerobic fitness compared to a moderate-intensity continuous training (MICT). Moreover, in patients with AF, time in AF was reduced of -3.3±7.2% after 12 weeks of HIIT compared to an increased time in AF of 4.2±11.8% in a control group without exercise. Whilst this highlights the potency of HIIT, no previous study has directly compared the effects of HIIT vs. MICT in AF patients on AF burden.

Cardiovascular physiological mechanism(s). Patients with AF exhibit cardiac and vascular dysfunction. However, exercise training improves cardiac and vascular function in human, but the effects are unknown in AF patients. This knowledge is important to improve management of patients with AF with an optimal training prescription. Research on long-term effects and safety related to high-intensity exercise in AF patients is therefore warranted. The findings of the optimal training prescription will help us to update and improve the current guidelines.

Building on the latest scientific insights, the overall aim of this proposal is to determine the optimal intensity for reducing the AF burden. Moreover, the understanding of the underlying mechanisms could help us to determine the cardiovascular adaptations related to exercise training (HIIT or MICT).

Taken together, this study will answer these two questions:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Presence of non-permanent AF
  • •> 18 years old

排除标准

  • •Performing endurance training at high intensity >2 times/week or at moderate intensity >3 times/week;
  • •Previous cardiac surgery not related to AF;
  • •LVEF <45%;
  • •Severe coronary artery disease non-suitable for revascularization;
  • •Significant cardiac valve disease;
  • •Implanted cardiac pacemaker;
  • •And restriction to cardiopulmonary exercise testing or severe intolerance to exercise.

研究组 & 干预措施

High-intensity interval training

Experimental

Patients will cycle or walk/run four intervals of four-min at high intensity with the aim to reach 80-90% of peak oxygen consumption, 90-95% of peak heart rate, 15-17 Borg scale, shortness of breath). Each interval is separated by a three-min active recovery, at 50-60% of peak oxygen consumption or 70-75% of peak heart rate. Total exercise time will be 38 min including the warm-up and cool-down.

干预措施: High-intensity interval training (Other)

Moderate-intensity continuous training

Active Comparator

Patients will cycle or walk/run continuously at moderate intensity (50-60% of peak oxygen consumption, 70-75% of peak heart rate) for 37 min. Total exercise time will be 47 min for the moderate-intensity continuous training group including warm-up and cool-down (isoenergetic compared to high-intensity interval training).

干预措施: Moderate-intensity continuous training (Other)

Control

No Intervention

The control group will continue their habits without increasing the level of physical activity nor participate to any supervised exercise training.

结局指标

主要结局

Change in burden of atrial fibrillation

时间窗: baseline and 3 months post rhythm control procedure

Burden of atrial fibrillation (number of episodes) continually measured, and reported by the patient. Measured by Huawei Band 4 and 6

次要结局

  • Health related quality of life(baseline and 3 months post rhythm control procedure)
  • Strain-area loop(baseline and 3 months post rhythm control procedure)
  • Carotid structure(baseline and 3 months post rhythm control procedure)
  • Peripheral endothelial function(baseline and 3 months post rhythm control procedure)
  • Physical activity level(baseline and 3 months post rhythm control procedure)
  • Myocardial strain(baseline and 3 months post rhythm control procedure)
  • Maximal oxygen uptake(baseline and 3 months post rhythm control procedure)
  • Central endothelial function(baseline and 3 months post rhythm control procedure)
  • Resting atrial and ventricular function(baseline and 3 months post rhythm control procedure)
  • Atrial and ventricular function during exercise(baseline and 3 months post rhythm control procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验