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High-Intensity Aerobic Lifelong Training--AF (HALT-AF)

2019年12月18日 更新者:University of Minnesota

High-Intensity Interval Training and Moderate-Intensity Continuous Training in Reducing Atrial Fibrillation Burden

This study is a single-center RCT. Potential subjects with symptomatic non-permanent AF will be enrolled to determine the effect of sprint interval training (SIT) in comparison to moderate-intensity continuous training (MICT) and non-exercise control in reducing AF burden. The Investigators will enroll 60 patients during the first 12 months of the study. Baseline data collection will be conducted during the first month after enrollment. After baseline data collection, subjects will be randomized (1:1:1) to SIT vs. MICT vs. non-exercise controls. The exercise training will last for 3 months followed by final data collection which will be completed in 1 month.

研究概览

详细说明

Atrial fibrillation (AF) is the most common heart rhythm abnormality in the general population. Current recommended methods to maintain sinus rhythm or reduce AF burden (% time a person is in AF) in patients with non-permanent AF are costly and ineffective. Hence, there is an urgent need to discover novel inexpensive strategies to reduce AF burden. It is well-established that regular aerobic exercise reduces cardiovascular morbidity and mortality; however, adherence to regular exercise is poor rendering it an ineffective public health strategy. Evidence is emerging to suggest that traditional moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT) may be associated with lower AF burden. Compared with traditional MICT, HIIT is possibly more time-efficient; hence, it may promote adherence. Since lack of time is the most common reason for poor adherence to regular exercise, the time-efficiency of HIIT holds promise to be a "game-changer". However, many knowledge gaps remain. First, HIIT has never been compared directly with MICT in relation to AF burden; thus, whether HIIT is comparable or superior to MICT is unknown. Second, the time commitment required for a "conventional" HIIT program (120 mins/week) is not substantially less than the recommended MICT (150 mins/week); hence, it is doubtful that it can be a real "game-changer" in terms of promoting adherence. Third, HIIT performed using a cycle ergometer is a safer alternative to the treadmill in older adults, but has not been evaluated in patients with AF. Finally, mechanisms underlying the salutary benefits of exercise in relation to AF burden remain unknown. To address these knowledge gaps, the investigators will evaluate an innovative HIIT program-sprint interval training (SIT)-using a cycle ergometer that only requires 10 minutes per session and 30 minutes per week, in contrast to the "conventional" HIIT program that requires 40 minutes per session and 120 minutes per week. In this pilot randomized controlled trial (RCT), the investigators will randomize 60 subjects with non-permanent AF (1:1:1) to SIT vs. MICT vs. no exercise control. At enrollment, these subjects will undergo heart rhythm monitoring by a non-invasive ambulatory heart rhythm monitor, V02 max testing, assessment of cardiac size and function by cardiac MRI, and assessment of AF symptom severity; these measures will be repeated at 3 months.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • : Patients with symptomatic non-permanent AF and aged 18-65 years who are sedentary (activity ≤0.5 hours/week of regular exercise) and seen by Dr. Chen or his cardiology colleagues at Clinics and Surgery Center (CSC), other Fairview cardiology clinics, and University of Minnesota Medical Center (UMMC). Patients will be screened and enrolled by a research coordinator.

Exclusion Criteria:

  • Individuals lacking the capacity to consent for themselves will not be included, previous open heart surgery, previous catheter ablation for AF, LVEF <45%, significant cardiac valve disease, coronary heart disease without complete revascularization, implanted cardiac electronic device, or GFR <30 mL/min/1.73 m2

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:High intensity interval training
Exercise training will be conducted 3 times per week using cycle ergometers at commercial fitness facilities for 12 weeks 2 minute warmup/3 minute cooldown- at 50W Intensity- 3 X 20-second sprint interval cycling -as fast as possible at 90-95% peak power low intensity- 2 X 2 minute cycling at slow pace 50W
exercise by use of stationary cycles
有源比较器:Moderate intensity continuous training
Exercise training will be conducted 3 times per week using cycle ergometers at commercial fitness facilities for 12 weeks 2 minute warmup/3 minute cooldown- at 50W Intensity- 45 minutes of continuous cycling at 45-60% peak power
exercise by use of stationary cycles
有源比较器:No exercise
No excercise training will be done
no exercise training will be given and no exercise will be added to subjects routine

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in AF burden
大体时间:3 months
After 12 weeks of exercise training , HIIT and MICT will be comparable but better than non-exercise control in AFburden(% of time a person is in AF) by using an ambulatory patch monitor
3 months

次要结果测量

结果测量
措施说明
大体时间
Change in left atrial and left ventricular size and function
大体时间:3 months
After 12 weeks of exercise training HIIT and MICT will be comparable but better than non-exercise control as Cardiac MRI will be completed to assess LV and LA volumes and function and LV fibrosis
3 months
change in clinical outcomes
大体时间:3 months
The favorable effect of HIIT and MICT over non exercise control on clinical outcomes will be attenuated after after for secondary outcomes, suggesting that the latter mediate the clinical benefits of regular aerobic exercise
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Lin Yee Chen, MD,MBBS,MS、University of Minnesota

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年5月1日

初级完成 (实际的)

2019年12月18日

研究完成 (实际的)

2019年12月18日

研究注册日期

首次提交

2017年7月27日

首先提交符合 QC 标准的

2017年8月1日

首次发布 (实际的)

2017年8月7日

研究记录更新

最后更新发布 (实际的)

2019年12月20日

上次提交的符合 QC 标准的更新

2019年12月18日

最后验证

2019年12月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 1703M11461

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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