Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control gruop | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| change in physical capacity | Measured by Peak VO2 via ergospirometry testing | 1, 4 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mental component scale | Measured by the mental component scale (MCS) in the SF-36 questionnaire | 1, 4, 6, 12 and 24 months |
Not provided
Inclusion Criteria:
Patients:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32750373 | Derived | 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. | |
| 31058705 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control Group | Other | usual follow-up Standard follow-up at the participating heart center |
|
| 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. |
| 23430599 | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |