Clinical trial NCT01523145: CopenHeartRFA - Integrated Rehabilitation of Patients Treated for Atrial Fibrillation With Radio Frequency Ablation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Radio Frequency Ablation
Rehabilitation
Physical capacity
Quality of life
Integrated rehabilitation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen Trial Unit, Center for Clinical Intervention Research
First posted: 2012-02-01
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in physical capacity
timeFrame: 1, 4 and 12 months
Secondary outcomes:
measure: Change in mental component scale
timeFrame: 1, 4, 6, 12 and 24 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Signe S Risom, RN, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte
name: Selina K Berg, MScN, ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital Rigshospitalet, National Institute of Public Health, University of Southern Denmark
name: Ann-Dorthe O Zwisler, MD, ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Jesper H Svendsen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Risom SS, Zwisler AD, Sibilitz KL, Rasmussen TB, Taylor RS, Thygesen LC, Madsen TS, Svendsen JH, Berg SK. Cardiac Rehabilitation for Patients Treated for Atrial Fibrillation With Ablation Has Long-Term Effects: 12-and 24-Month Follow-up Results From the Randomized CopenHeartRFA Trial. Arch Phys Med Rehabil. 2020 Nov;101(11):1877-1886. doi: 10.1016/j.apmr.2020.06.026. Epub 2020 Aug 1.
citation: Risom SS, Lind J, Dickson VV, Berg SK. Exploring the Mechanism of Effectiveness of a Psychoeducational Intervention in a Rehabilitation Program (CopenHeartRFA) for Patients Treated With Ablation for Atrial Fibrillation: A Mixed Methods Study. J Cardiovasc Nurs. 2019 Jul/Aug;34(4):336-343. doi: 10.1097/JCN.0000000000000584.
citation: Risom SS, Zwisler AD, Rasmussen TB, Sibilitz KL, Svendsen JH, Gluud C, Hansen JL, Winkel P, Thygesen LC, Perhonen M, Hansen J, Dunbar SB, Berg SK. The effect of integrated cardiac rehabilitation versus treatment as usual for atrial fibrillation patients treated with ablation: the randomised CopenHeartRFA trial protocol. BMJ Open. 2013 Feb 20;3(2):e002377. doi: 10.1136/bmjopen-2012-002377. Print 2013.