CopenHeartRFA - Integrated Rehabilitation of Patients Treated for Atrial Fibrillation With Radio Frequency Ablation

Study Overview
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Brief Summary
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Atrial fibrillation is the most common arrhythmia and affect 1-2 % of the population in the western world. Atrial fibrillation can be treated with a relatively new procedure, called radiofrequency ablation. The aim of this study is to explore if patients treated with ablation for atrial fibrillation, benefit from an integrated rehabilitation programme, that consist of physical training and psycho-educative consultations with a specialised nurse. The hypothesis is, that integrated rehabilitation can improve mental health, physical capacity and other factors.

Detailed Description
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1-2 % of the population in the western world live with atrial fibrillation. One way to treat atrial fibrillation is with radiofrequency ablation. Ablation is a relatively new treatment and therefore only few studies has been exploring how the patients are doing after discharge. In Denmark the patients are not offered rehabilitation, only brief follow-up with a doctor. Therefore the aim of this study is to explore if the patients will benefit from a integrated rehabilitation programme consisting of physical training and psycho-educational intervention. A randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients treated for atrial fibrillation with radiofrequency ablation. The trial is a parallel arm design. A mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. The intervention consists of four psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. A qualitative post-intervention study will explore rehabilitation participation experiences. The hypothesis is, that integrated rehabilitation can improve mental health, physical capacity, self-rated health, quality of life, sleep-quality and reduce anxiety, depression, health care utilisation, work cessation and mortality in patients treated for atrial fibrillation with radiofrequency ablation and that it is cost effective. 210 patients will be included. Questionnaires, cardiopulmonary testing, 6 minute walking test and qualitative interviews will be used to evaluate the effect and meaning of the programme.

Official Title
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CopenHeartRFA - A Randomized Clinical Trial Investigating the Effect and Meaning of Integrated Rehabilitation Versus Usual Follow-up of Patients Treated for Atrial Fibrillation With Radio Frequency Ablation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Behavioral: Rehabilitation
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: treated for atrial fibrillation with radiofrequency ablation on Rigshospitalet, Denmark 18 years or older speaking and understanding Danish providing written informed consent Exclusion Criteria: unable to understand study instructions who are pregnant or breastfeeding with considerable illness in the musculoskeletal system or with physical disability, which complicates exercise training who does strenuous physical training several times a week on competition level who does not wish to participate

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Rehabilitation<br>* Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of twelve weeks) and psychoeducational care (4 sessions over 6 months)<br>|
| Experimental: Control gruop<br> | Other: Control Group<br>* usual follow-up Standard follow-up at the participating heart center<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in physical capacity | Measured by Peak VO2 via ergospirometry testing | 1, 4 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mental component scale | Measured by the mental component scale (MCS) in the SF-36 questionnaire | 1, 4, 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Radio Frequency Ablation, Rehabilitation, Physical capacity, Quality of life, Integrated rehabilitation