The Norwegian Exercise in Atrial Fibrillation Trial - An Open-label, Multicenter Randomized Controlled Trial Comparing an eHealth-based Exercise Intervention With Usual Care After 12 Months Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Total time-in-AF(%)
研究概览
简要总结
Atrial fibrillation (AF) patients suffer a high symptom burden and reduced quality of life (QoL), high hospitalization rates and few effective treatment options. They have a high burden of cardiovascular risk factors and events. Lifestyle changes and exercise is a cornerstone of management in most chronic cardiac conditions and holds promise in AF, but the evidence is sparse and specific guidelines for exercise do not exist for AF patients. NEXAF is a large-scale multicenter randomized trial to determine the feasibility and effects of exercise on patient-reported and clinical outcomes. All patients will undergo continuous rhythm monitoring, enabling assessment of duration, frequency and total time of AF episodes. The overall aim of the study is to provide documentation for clinical exercise recommendations in AF. The objectives are to examine the effects of a 1-year exercise intervention in AF patients on (i) QoL and symptom burden, (ii) time-in-AF, and peak oxygen uptake, cardiac structure and function, cardiovascular risk factors and use of healthcare resources.
详细描述
A pre-planned substudy will examine the immediate (24-h to 7 days) effects of vigorous exercise on AF-burden in a subgroup of participants from each arm. Two main outcomes are prespecified: (i) mean time-in-AF measured by an insertable cardiac monitor (ICM) 24 hours after maximal exercise testing at baseline and follow-up compared to mean of the last week before exercise test. (ii) Normal cardiac biomarker response for Troponin and NT-proBNP to acute exercise (0h, 3h, 24h post exercise). Secondary outcomes are mean time-in-AF the consecutive week and post-exercise heart rate variability and number of atrial and ventricular extra systoles at the same time points. Further, changes in post-exercise responses after the intervention (12 months) and the effect on clinical outcomes will be examined.
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 (Investigator)
盲法说明
Participants are not blinded to group allocation. Researchers will be blinded to group allocation when performing statistical analyses. At study completion, a de-identified copy of the data will be extracted for statistical analyses. Information on group allocation will be kept at the Clinical research Unit in Mid-Norway and provided to the research team once a blinded interpretation of the results is finalized.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Diagnosed with paroxysmal or persistent AF in hospital registries
- •In sinus rhythm at baseline screening
- •Report <75 minutes per week of vigorous and/or <150 minutes of moderate intensity exercise the last three months
- •Use a smartphone
排除标准
- •Permanent AF or persistent AF with at least one continuous episode lasting ≥3 months the last year
- •AF as a complication of acute coronary syndromes, cardiothoracic surgery or infections
- •Planned ablation procedure next 12 months or ablated last 6 months without known recurrence
- •Unstable coronary heart disease
- •De-compensated heart failure
- •Left ventricular ejection fraction <40%
- •At least moderate to severe mitral or aortic pathology, or aortic aneurysms clinically incompatible with safe exercise
- •Moderate to severe chronic obstructive pulmonary disease (GOLD group C+D)
- •Ongoing severe cancer or active cancer treatment
- •Pacemaker or ICD
- •Pregnancy
- •Alcohol or drug abuse
- •Cognitive or serious psychiatric disease that may impede protocol compliance
- •Physical impairments or diseases hindering exercise or making exercise contraindicated
- •Resident of nursing home or other institution
- •Participation in conflicting research studies (i.e. lifestyle interventions)
研究组 & 干预措施
Control group
干预措施: Usual care (Other)
Exercise group
干预措施: Supervised home-based exercise (Behavioral)
结局指标
主要结局
Total time-in-AF(%)
时间窗: 12 months
Measured by implantable loop recorder over 12 months
Change in health-related quality of life and symptoms
时间窗: 12 months
Overall score (0-100) of the 20-item Atrial Fibrillation Effect and Quality of Life (AFEQT) questionnaire. The subscale scores on symptoms, daily activities, and treatment concern, respectively, and the overall score at 6 months, will aid to interpretation as secondary endpoints. Two questions regarding satisfaction with health care providers and treatment are not included in the overall score and will not be collected.
次要结局
- Frequency and duration of AF episodes(12 months)
- Frequency and severity of atrial fibrillation symptoms(6 and 12 months)
- Change in peak oxygen uptake (VO2peak)(12 months)
- Change in physical and mental dimensions of health(6 months and 12 months)
- Change in cardiovascular risk factors(12 months)
- Changes in cardiac volume and dimensions(12 months)
- Incident mortality, cardiovascular events, cardioversions, ablations and total hospitalization(12 months)
- Safety outcome parameters(12 months)
- Physical activity level and adherence(6 and 12 months.)