We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523145
First Posted: February 1, 2012
Last Update Posted: April 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark
  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
Intervention Model: Parallel Assignment
Masking: None (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 Selina Kikkenborg Berg, Rigshospitalet, Denmark:

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


Secondary Outcome Measures:
  • Change in mental component scale [ Time Frame: 1, 4, 6, 12 and 24 months ]
    Measured by the mental component scale (MCS) in the SF-36 questionnaire


Enrollment: 210
Study Start Date: December 2011
Study Completion Date: January 2016
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523145


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Selina Kikkenborg Berg, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01523145     History of Changes
Other Study ID Numbers: RHCopenHeartRFA
First Submitted: January 27, 2012
First Posted: February 1, 2012
Last Update Posted: April 19, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Selina Kikkenborg Berg, 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


To Top