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临床试验/NCT03035539
NCT03035539已完成不适用

Rehabilitation of Patients With Atrial Fibrillation

Aalborg University Hospital2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2012年5月最近更新:
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
58
试验地点
2
主要终点
Change in Quality of life measurement (AF-QoL 18 score) from baseline to 3, 6 and 12 months

研究概览

简要总结

The purpose of this study is to investigate whether a rehabilitation programme can improve the quality of life and reduce morbidity in patients with atrial fibrillation.

In addition, the study will map the economic costs and benefits of such a rehabilitation programme.

详细描述

Atrial fibrillation (AF) is the most frequent cardiac arrhythmia and is the cause of increased morbidity, mortality and socioeconomic costs.

Research conducted in recent years suggests that various pharmacological therapies and life style changes may affect the structural remodelling, thereby preventing the incidence of AF (primary prophylaxis) and a progression of the disease (secondary prophylaxis). These therapies, known as upstream therapy, include ace inhibitors/angiotensin II inhibitors, statins, the intake of n-3 polyunsaturated fatty acids and moderate physical exercise.

Furthermore, an important part of the treatment is to alleviate patients' symptoms, reduce the risk of thromboembolic complications and teach the patients to live with a chronic paroxysmal disease. Today, well-established pharmacological therapies are available, but there is only sparse knowledge of the effect of non-pharmacological therapies, how patients obtain information on the disease, how they learn how to cope with their symptoms, and how they relate to the uncertainty as to when they will experience the next symptom-producing attack of AF.

Cardiac rehabilitation is a collective term for the aftercare of patients with chronic heart failure. Cardiac rehabilitation is a cross-functional approach with participation of physicians, nurses, dieticians and smoking cessation instructors and is performed under the supervision of a cardiac specialist.

Cardiac rehabilitation includes: individually designed treatment plan, offer of patient information and education, support for smoking cessation, support for diet change, psychosocial support, optimisation of medical treatment and risk factor control, advice on physical exercise and maintenance of targets.

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)

盲法说明

Physiotherapists evaluating the physical capacity were masked.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Paroxysmal or persistent atrial fibrillation
  • Signed informed consent

排除标准

  • Participating in other clinical trials
  • Participating in other cardiac rehabilitation
  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, reversible or non-cardiac cause
  • Other cardiac disease
  • Unable to complete physical training

研究组 & 干预措施

Standard treatment

Active Comparator

Standard treatment after randomization

干预措施: Standard treatment (Other)

Cardiac Rehabilitation

Experimental

The rehabilitation programme includes education, physical exercise, optimisation of the medical treatment, and discussion of implications for the daily life of each participant.

干预措施: Cardiac rehabilitation (Other)

结局指标

主要结局

Change in Quality of life measurement (AF-QoL 18 score) from baseline to 3, 6 and 12 months

时间窗: Inclusion and at 3, 6 and 12 months

Change in Quality of life measurement (GAD7 score) from baseline to 3, 6 and 12 months

时间窗: Inclusion and at 3, 6 and 12 months

Change in Quality of life measurement (AFEQT score) from baseline to 3, 6 and 12 months

时间窗: Inclusion and at 3, 6 and 12 months

Change in Quality of life measurement (PHQ-9 score) from baseline to 3, 6 and 12 months

时间窗: Inclusion and at 3, 6 and 12 months

次要结局

  • Morbidity(12 months follow-up)
  • Change in maximum exercise capacity (calculated oxygen uptake) from baseline to 3 and 6 months(Inclusion and at 3 and 6 months follow up)
  • Health Economics (Cost-effectiveness analysis)(12 months follow-up)
  • Change in 5-repetition-sit-to-stand-test from baseline to 3 and 6 months(Inclusion and at 3 and 6 months follow up)
  • Change in 6 minute walk test from baseline to 3 and 6 months(Inclusion and at 3 and 6 months follow up)

研究者

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

Albert Marni Joensen

MD, PhD

Aalborg University Hospital

研究点 (2)

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