CopenHeartRFA - Integrated Rehabilitation of Patients Treated for Atrial Fibrillation With Radio Frequency Ablation
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||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|
- change in physical capacity [ Time Frame: 1, 4 and 12 months ] [ Designated as safety issue: Yes ]Measured by Peak VO2 via ergospirometry testing
- Change in mental component scale [ Time Frame: 1, 4, 6, 12 and 24 months ] [ Designated as safety issue: No ]Measured by the mental component scale (MCS) in the SF-36 questionnaire
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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)
|Experimental: Control gruop||
Other: Control Group
usual follow-up Standard follow-up at the participating heart center
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523145
|Contact: Signe S Risom, RN, MSc||+45 3545 firstname.lastname@example.org|
|Contact: Kirstine L Sibilitz, MD||+45 3545 email@example.com|
|Copenhagen, Denmark, 2100|
|Contact: Signe S Risom, RN, MSc +45 3545 2938 firstname.lastname@example.org|
|Principal Investigator:||Signe S Risom, RN, MSc||Rigshospitalet, Denmark|
|Principal Investigator:||Selina K Berg, MScN, ph.d.||Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte|
|Principal Investigator:||Ann-Dorthe O Zwisler, MD, ph.d.||Copenhagen University Hospital Rigshospitalet, National Institute of Public Health, University of Southern Denmark|
|Principal Investigator:||Jesper H Svendsen, MD, DMSc||Rigshospitalet, Denmark|