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

NCT01523145 | Completed DMC

• 1 other identifier: RHCopenHeartRFA
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• change in physical capacity

  Measured by Peak VO2 via ergospirometry testing

  1, 4 and 12 months

Secondary Outcomes (1)

• Change in mental component scale

  1, 4, 6, 12 and 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Rehabilitation

Control gruop

EXPERIMENTAL

Other: Control Group

Interventions

Rehabilitation BEHAVIORAL

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)

Intervention

Control Group OTHER

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

Control gruop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• treated for atrial fibrillation with radiofrequency ablation on Rigshospitalet, Denmark
• years or older
• speaking and understanding Danish
• providing written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (3)

• 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.

  PMID: 32750373 DERIVED

• 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.

  PMID: 31058705 DERIVED

• 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.

  PMID: 23430599 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rehabilitation; Control Groups

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 1, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2016
• Last Updated: April 19, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)