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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01523145
Enrollment
210
Registered
2012-02-01
Start date
2011-12-31
Completion date
2016-01-31
Last updated
2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Radio Frequency Ablation, Rehabilitation, Physical capacity, Quality of life, Integrated rehabilitation

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.

Interventions

BEHAVIORALRehabilitation

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)

OTHERControl Group

usual follow-up Standard follow-up at the participating heart center

Sponsors

Copenhagen Trial Unit, Center for Clinical Intervention Research
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in physical capacity1, 4 and 12 monthsMeasured by Peak VO2 via ergospirometry testing

Secondary

MeasureTime frameDescription
Change in mental component scale1, 4, 6, 12 and 24 monthsMeasured by the mental component scale (MCS) in the SF-36 questionnaire

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026