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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Rigshospitalet, Denmark
Sponsor:
Collaborator:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01523145
First received: January 27, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Behavioral: Rehabilitation
Other: Control Group

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • change in physical capacity [ Time Frame: 1, 4 and 12 months ] [ Designated as safety issue: Yes ]
    Measured by Peak VO2 via ergospirometry testing


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 210
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)
Arms Assigned Interventions
Experimental: 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)
Experimental: Control gruop Other: Control Group
usual follow-up Standard follow-up at the participating heart center

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523145

Contacts
Contact: Signe S Risom, RN, MSc +45 3545 2938 signe.stelling.risom@rh.regionh.dk
Contact: Kirstine L Sibilitz, MD +45 3545 1205 kirstine.laerum.sibilitz@rh.regionh.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Signe S Risom, RN, MSc    +45 3545 2938    signe.stelling.risom@rh.regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Selina Kikkenborg Berg, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01523145     History of Changes
Other Study ID Numbers: RHCopenHeartRFA
Study First Received: January 27, 2012
Last Updated: December 7, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Atrial fibrillation
Radio Frequency Ablation
Rehabilitation
Physical capacity
Quality of life
Integrated rehabilitation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014