Rehabilitation of Patients With Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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. There is strong evidence that rehabilitation has a beneficial effect on the quality of life, but also on morbidity and mortality from other heart diseases than AF. Currently, patients with the diagnosis of AF are not offered a rehabilitation programme, and there is sparse knowledge of the effect of rehabilitation on patients' quality of life and morbidity. It is therefore of vital importance to develop and implement a rehabilitation programme aimed at improving the quality of life of patients with AF and, possibly, preventing admissions and the development of AF. All participants are examined by exercise ECG to assess their maximum physical capacity (estimated oxygen uptake), Six-minute-walk test and Five-repetition-sit-to-stand test at inclusion and after 3 and 6 months. At inclusion and at the end of the study each participant is to complete the QOL questionnaire, AF-QOL-18 and AFEQT, and questionnaire on lifestyle, heart symptoms, risk factors, medical treatment and sickness absence, if any, visits to own GP due to AFLI and hospital admissions. The resource consumption for each individual participant is regularly recorded. Instructors and physiotherapists record their total time consumption (preparation and confrontation time) as well as patients' total time consumption (transportation and time for education/exercise. Furthermore, travel expenses in relation to rehabilitation are recorded. In addition the patients are to complete a questionnaire on lifestyle (Euroqol eq-5d) at inclusion and after 1, 3, 6 and twelve months, respectively, for use in the cost-benefit analysis. Data on visits to own GP are collected from the Danish Health Insurance Registry at the end of the study.

Official Title
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Rehabilitation of Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Cardiac rehabilitation
* Other: Standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paroxysmal or persistent atrial fibrillation Signed informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>Standard treatment after randomization | Other: Standard treatment<br>* Standard treatment<br>|
| Experimental: Cardiac Rehabilitation<br>The rehabilitation programme includes education, physical exercise, optimisation of the medical treatment, and discussion of implications for the daily life of each participant. | Other: Cardiac rehabilitation<br>* AF specific cardiac rehabilitation Group education 1 hour each week for 3 months Physical training 1 hour each week for 3 months with physiotherapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life measurement (AFEQT score) from baseline to 3, 6 and 12 months |  | Inclusion and at 3, 6 and 12 months | 
| Change in Quality of life measurement (AF-QoL 18 score) from baseline to 3, 6 and 12 months |  | Inclusion and at 3, 6 and 12 months | 
| Change in Quality of life measurement (GAD7 score) from baseline to 3, 6 and 12 months |  | 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 |  | Inclusion and at 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | 12 months follow-up | 
| Health Economics (Cost-effectiveness analysis) | Evaluated by - EQ-5 | 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 | 
| Change in 6 minute walk test from baseline to 3 and 6 months |  | Inclusion and at 3 and 6 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation