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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523145
• Other study ID #: RHCopenHeartRFA
• Status: Completed
• Phase: N/A
• First received: January 27, 2012
• Last updated: April 18, 2016
• Start date: December 2011
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: January 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Rehabilitation
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)

Other:
• Control Group
usual follow-up Standard follow-up at the participating heart center

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen Trial Unit, Center for Clinical Intervention Research

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in physical capacity	Measured by Peak VO2 via ergospirometry testing	1, 4 and 12 months	Yes
Secondary	Change in mental component scale	Measured by the mental component scale (MCS) in the SF-36 questionnaire	1, 4, 6, 12 and 24 months	No

External Links

•   The CopenHeart homepage