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

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT01523145
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-01
• Primary Completion: 2014-12
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in physical capacity	1, 4 and 12 months	Measured by Peak VO2 via ergospirometry testing

Secondary Outcome Measures

Name	Time	Method
Change in mental component scale	1, 4, 6, 12 and 24 months	Measured by the mental component scale (MCS) in the SF-36 questionnaire

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark