Atrial FibrillationNCT03035539
Rehabilitation of Patients With Atrial Fibrillation
A study testing Cardiac rehabilitation and Standard treatment in people with Atrial Fibrillation, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate whether a rehabilitation programme can improve the quality of life and reduce morbidity in patients with atrial fibrillation. In addition, the study will map the economic costs and benefits of such a rehabilitation programme. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cardiac rehabilitation and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- May 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paroxysmal or persistent atrial fibrillation
- Signed informed consent
Who cannot join
- Participating in other clinical trials
- Participating in other cardiac rehabilitation
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, reversible or non-cardiac cause
- Other cardiac disease
- Unable to complete physical training
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate whether a rehabilitation programme can improve the quality of life and reduce morbidity in patients with atrial fibrillation.
In addition, the study will map the economic costs and benefits of such a rehabilitation programme.
Read the detailed description
Atrial fibrillation (AF) is the most frequent cardiac arrhythmia and is the cause of increased morbidity, mortality and socioeconomic costs.
Research conducted in recent years suggests that various pharmacological therapies and life style changes may affect the structural remodelling, thereby preventing the incidence of AF (primary prophylaxis) and a progression of the disease (secondary prophylaxis). These therapies, known as upstream therapy, include ace inhibitors/angiotensin II inhibitors, statins, the intake of n-3 polyunsaturated fatty acids and moderate physical exercise.
Furthermore, an important part of the treatment is to alleviate patients' symptoms, reduce the risk of thromboembolic complications and teach the patients to live with a chronic paroxysmal disease. Today, well-established pharmacological therapies are available, but there is only sparse knowledge of the effect of non-pharmacological therapies, how patients obtain information on the disease, how they learn how to cope with their symptoms, and how they relate to the uncertainty as to when they will experience the next symptom-producing attack of AF.
Cardiac rehabilitation is a collective term for the aftercare of patients with chronic heart failure. Cardiac rehabilitation is a cross-functional approach with participation of physicians, nurses, dieticians and smoking cessation instructors and is performed under the supervision of a cardiac specialist.
Cardiac rehabilitation includes: individually designed treatment plan, offer of patient information and education, support for smoking cessation, support for diet change, psychosocial support, optimisation of medical treatment and risk factor control, advice on physical exercise and maintenance of targets.
There is strong evidence that rehabilitation has a beneficial effect on the quality of life, but also on morbidity and mortality from other heart diseases than AF.
Currently, patients with the diagnosis of AF are not offered a rehabilitation programme, and there is sparse knowledge of the effect of rehabilitation on patients' quality of life and morbidity.
It is therefore of vital importance to develop and implement a rehabilitation programme aimed at improving the quality of life of patients with AF and, possibly, preventing admissions and the development of AF.
All participants are examined by exercise ECG to assess their maximum physical capacity (estimated oxygen uptake), Six-minute-walk test and Five-repetition-sit-to-stand test at inclusion and after 3 and 6 months.
At inclusion and at the end of the study each participant is to complete the QOL questionnaire, AF-QOL-18 and AFEQT, and questionnaire on lifestyle, heart symptoms, risk factors, medical treatment and sickness absence, if any, visits to own GP due to AFLI and hospital admissions.
The resource consumption for each individual participant is regularly recorded. Instructors and physiotherapists record their total time consumption (preparation and confrontation time) as well as patients' total time consumption (transportation and time for education/exercise. Furthermore, travel expenses in relation to rehabilitation are recorded. In addition the patients are to complete a questionnaire on lifestyle (Euroqol eq-5d) at inclusion and after 1, 3, 6 and twelve months, respectively, for use in the cost-benefit analysis. Data on visits to own GP are collected from the Danish Health Insurance Registry at the end of the study.
- Conditions
- Atrial Fibrillation
- Being tested
- Cardiac rehabilitation, Standard treatment
- Keywords
- Rehabilitation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationOther
AF specific cardiac rehabilitation Group education 1 hour each week for 3 months Physical training 1 hour each week for 3 months with physiotherapist
Standard treatmentOther
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Standard treatment after randomization Receives: Other: Standard treatment |
| Cardiac Rehabilitation | Experimental | The rehabilitation programme includes education, physical exercise, optimisation of the medical treatment, and discussion of implications for the daily life of each participant. Receives: Other: Cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life measurement (AFEQT score) from baseline to 3, 6 and 12 months
Measured: Inclusion and at 3, 6 and 12 months
Change in Quality of life measurement (AF-QoL 18 score) from baseline to 3, 6 and 12 months
Measured: Inclusion and at 3, 6 and 12 months
Change in Quality of life measurement (GAD7 score) from baseline to 3, 6 and 12 months
Measured: Inclusion and at 3, 6 and 12 months
Change in Quality of life measurement (PHQ-9 score) from baseline to 3, 6 and 12 months
Measured: Inclusion and at 3, 6 and 12 months
Secondary outcomes (5)
Morbidity
Measured: 12 months follow-up
Health Economics (Cost-effectiveness analysis)
Evaluated by
- EQ-5
Measured: 12 months follow-up
Change in maximum exercise capacity (calculated oxygen uptake) from baseline to 3 and 6 months
Measured: Inclusion and at 3 and 6 months follow up
Change in 6 minute walk test from baseline to 3 and 6 months
Measured: Inclusion and at 3 and 6 months follow up
Change in 5-repetition-sit-to-stand-test from baseline to 3 and 6 months
Measured: Inclusion and at 3 and 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Marni Joensen, Aalborg University Hospital
- Investigators
- Albert Marni Joensen, MD, PhD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035539
- Sponsor's protocol ID
- N-20120002
- Status last verified
- Jul 2017
- First submitted
- 13 Jul 2012
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available.
PubMed 20802247Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.
PubMed 12401529Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, Singer DE. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003 Sep 11;349(11):1019-26. doi: 10.1056/NEJMoa022913.
PubMed 12968085Savelieva I, Kourliouros A, Camm J. Primary and secondary prevention of atrial fibrillation with statins and polyunsaturated fatty acids: review of evidence and clinical relevance. Naunyn Schmiedebergs Arch Pharmacol. 2010 Mar;381(3):1-13. doi: 10.1007/s00210-009-0468-y. Epub 2009 Nov 25.
PubMed 19937318Anand K, Mooss AN, Hee TT, Mohiuddin SM. Meta-analysis: inhibition of renin-angiotensin system prevents new-onset atrial fibrillation. Am Heart J. 2006 Aug;152(2):217-22. doi: 10.1016/j.ahj.2006.01.007.
PubMed 16875900Aizer A, Gaziano JM, Cook NR, Manson JE, Buring JE, Albert CM. Relation of vigorous exercise to risk of atrial fibrillation. Am J Cardiol. 2009 Jun 1;103(11):1572-7. doi: 10.1016/j.amjcard.2009.01.374. Epub 2009 Apr 22.
PubMed 19463518Mozaffarian D, Furberg CD, Psaty BM, Siscovick D. Physical activity and incidence of atrial fibrillation in older adults: the cardiovascular health study. Circulation. 2008 Aug 19;118(8):800-7. doi: 10.1161/CIRCULATIONAHA.108.785626. Epub 2008 Aug 4.
PubMed 18678768Mont L, Sambola A, Brugada J, Vacca M, Marrugat J, Elosua R, Pare C, Azqueta M, Sanz G. Long-lasting sport practice and lone atrial fibrillation. Eur Heart J. 2002 Mar;23(6):477-82. doi: 10.1053/euhj.2001.2802.
PubMed 11863350Hegbom F, Sire S, Heldal M, Orning OM, Stavem K, Gjesdal K. Short-term exercise training in patients with chronic atrial fibrillation: effects on exercise capacity, AV conduction, and quality of life. J Cardiopulm Rehabil. 2006 Jan-Feb;26(1):24-9. doi: 10.1097/00008483-200601000-00005.
PubMed 16617223Osbak PS, Mourier M, Kjaer A, Henriksen JH, Kofoed KF, Jensen GB. A randomized study of the effects of exercise training on patients with atrial fibrillation. Am Heart J. 2011 Dec;162(6):1080-7. doi: 10.1016/j.ahj.2011.09.013.
PubMed 22137082European Association of Cardiovascular Prevention and Rehabilitation Committee for Science Guidelines; EACPR; Corra U, Piepoli MF, Carre F, Heuschmann P, Hoffmann U, Verschuren M, Halcox J; Document Reviewers; Giannuzzi P, Saner H, Wood D, Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP. Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur Heart J. 2010 Aug;31(16):1967-74. doi: 10.1093/eurheartj/ehq236. Epub 2010 Jul 19.
PubMed 20643803Du H, Newton PJ, Salamonson Y, Carrieri-Kohlman VL, Davidson PM. A review of the six-minute walk test: its implication as a self-administered assessment tool. Eur J Cardiovasc Nurs. 2009 Mar;8(1):2-8. doi: 10.1016/j.ejcnurse.2008.07.001. Epub 2008 Aug 9.
PubMed 18694656Bohannon RW. Test-retest reliability of the five-repetition sit-to-stand test: a systematic review of the literature involving adults. J Strength Cond Res. 2011 Nov;25(11):3205-7. doi: 10.1519/JSC.0b013e318234e59f.
PubMed 21904240Arribas F, Ormaetxe JM, Peinado R, Perulero N, Ramirez P, Badia X. Validation of the AF-QoL, a disease-specific quality of life questionnaire for patients with atrial fibrillation. Europace. 2010 Mar;12(3):364-70. doi: 10.1093/europace/eup421. Epub 2010 Jan 6.
PubMed 20056594Spertus J, Dorian P, Bubien R, Lewis S, Godejohn D, Reynolds MR, Lakkireddy DR, Wimmer AP, Bhandari A, Burk C. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):15-25. doi: 10.1161/CIRCEP.110.958033. Epub 2010 Dec 15.
PubMed 21160035
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03035539
- Acronym / sponsor ID
- N-20120002
- Conditions
- Atrial Fibrillation
- Keywords
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether a rehabilitation programme can improve the quality of life and reduce morbidity in patients with atrial fibrillation.
In addition, the study will map the economic costs and benefits of such a rehabilitation programme.
Detailed description
Atrial fibrillation (AF) is the most frequent cardiac arrhythmia and is the cause of increased morbidity, mortality and socioeconomic costs.
Research conducted in recent years suggests that various pharmacological therapies and life style changes may affect the structural remodelling, thereby preventing the incidence of AF (primary prophylaxis) and a progression of the disease (secondary prophylaxis). These therapies, known as upstream therapy, include ace inhibitors/angiotensin II inhibitors, statins, the intake of n-3 polyunsaturated fatty acids and moderate physical exercise.
Furthermore, an important part of the treatment is to alleviate patients' symptoms, reduce the risk of thromboembolic complications and teach the patients to live with a chronic paroxysmal disease. Today, well-established pharmacological therapies are available, but there is only sparse knowledge of the effect of non-pharmacological therapies, how patients obtain information on the disease, how they learn how to cope with their symptoms, and how they relate to the uncertainty as to when they will experience the next symptom-producing attack of AF.
Cardiac rehabilitation is a collective term for the aftercare of patients with chronic heart failure. Cardiac rehabilitation is a cross-functional approach with participation of physicians, nurses, dieticians and smoking cessation instructors and is performed under the supervision of a cardiac specialist.
Cardiac rehabilitation includes: individually designed treatment plan, offer of patient information and education, support for smoking cessation, support for diet change, psychosocial support, optimisation of medical treatment and risk factor control, advice on physical exercise and maintenance of targets.
There is strong evidence that rehabilitation has a beneficial effect on the quality of life, but also on morbidity and mortality from other heart diseases than AF.
Currently, patients with the diagnosis of AF are not offered a rehabilitation programme, and there is sparse knowledge of the effect of rehabilitation on patients' quality of life and morbidity.
It is therefore of vital importance to develop and implement a rehabilitation programme aimed at improving the quality of life of patients with AF and, possibly, preventing admissions and the development of AF.
All participants are examined by exercise ECG to assess their maximum physical capacity (estimated oxygen uptake), Six-minute-walk test and Five-repetition-sit-to-stand test at inclusion and after 3 and 6 months.
At inclusion and at the end of the study each participant is to complete the QOL questionnaire, AF-QOL-18 and AFEQT, and questionnaire on lifestyle, heart symptoms, risk factors, medical treatment and sickness absence, if any, visits to own GP due to AFLI and hospital admissions.
The resource consumption for each individual participant is regularly recorded. Instructors and physiotherapists record their total time consumption (preparation and confrontation time) as well as patients' total time consumption (transportation and time for education/exercise. Furthermore, travel expenses in relation to rehabilitation are recorded. In addition the patients are to complete a questionnaire on lifestyle (Euroqol eq-5d) at inclusion and after 1, 3, 6 and twelve months, respectively, for use in the cost-benefit analysis. Data on visits to own GP are collected from the Danish Health Insurance Registry at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Other: Standard treatmentStandard treatment after randomization |
| Cardiac Rehabilitation | Experimental | Other: Cardiac rehabilitationThe rehabilitation programme includes education, physical exercise, optimisation of the medical treatment, and discussion of implications for the daily life of each participant. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Paroxysmal or persistent atrial fibrillation
- Signed informed consent
Key exclusion criteria (5 listed)
- Participating in other clinical trials
- Participating in other cardiac rehabilitation
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, reversible or non-cardiac cause
- Other cardiac disease
- Unable to complete physical training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitationAF specific cardiac rehabilitation Group education 1 hour each week for 3 months Physical training 1 hour each week for 3 months with physiotherapist | Other | Cardiac Rehabilitation |
| Standard treatmentStandard treatment | Other | Standard treatment |
Primary outcome
Change in Quality of life measurement (AFEQT score) from baseline to 3, 6 and 12 months
Time frame: Inclusion and at 3, 6 and 12 months
Change in Quality of life measurement (AF-QoL 18 score) from baseline to 3, 6 and 12 months
Time frame: Inclusion and at 3, 6 and 12 months
Change in Quality of life measurement (GAD7 score) from baseline to 3, 6 and 12 months
Time frame: Inclusion and at 3, 6 and 12 months
Change in Quality of life measurement (PHQ-9 score) from baseline to 3, 6 and 12 months
Time frame: Inclusion and at 3, 6 and 12 months
5 secondary outcomes
Morbidity
Time frame: 12 months follow-up
Health Economics (Cost-effectiveness analysis)
Time frame: 12 months follow-up
Change in maximum exercise capacity (calculated oxygen uptake) from baseline to 3 and 6 months
Time frame: Inclusion and at 3 and 6 months follow up
Change in 6 minute walk test from baseline to 3 and 6 months
Time frame: Inclusion and at 3 and 6 months follow up
Change in 5-repetition-sit-to-stand-test from baseline to 3 and 6 months
Time frame: Inclusion and at 3 and 6 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Background: PubMed 20802247European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available.
- Background: PubMed 12401529Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.
- Background: PubMed 12968085Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, Singer DE. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003 Sep 11;349(11):1019-26. doi: 10.1056/NEJMoa022913.
- Background: PubMed 19937318Savelieva I, Kourliouros A, Camm J. Primary and secondary prevention of atrial fibrillation with statins and polyunsaturated fatty acids: review of evidence and clinical relevance. Naunyn Schmiedebergs Arch Pharmacol. 2010 Mar;381(3):1-13. doi: 10.1007/s00210-009-0468-y. Epub 2009 Nov 25.
- Background: PubMed 16875900Anand K, Mooss AN, Hee TT, Mohiuddin SM. Meta-analysis: inhibition of renin-angiotensin system prevents new-onset atrial fibrillation. Am Heart J. 2006 Aug;152(2):217-22. doi: 10.1016/j.ahj.2006.01.007.
- Background: PubMed 19463518Aizer A, Gaziano JM, Cook NR, Manson JE, Buring JE, Albert CM. Relation of vigorous exercise to risk of atrial fibrillation. Am J Cardiol. 2009 Jun 1;103(11):1572-7. doi: 10.1016/j.amjcard.2009.01.374. Epub 2009 Apr 22.
- Background: PubMed 18678768Mozaffarian D, Furberg CD, Psaty BM, Siscovick D. Physical activity and incidence of atrial fibrillation in older adults: the cardiovascular health study. Circulation. 2008 Aug 19;118(8):800-7. doi: 10.1161/CIRCULATIONAHA.108.785626. Epub 2008 Aug 4.
- Background: PubMed 11863350Mont L, Sambola A, Brugada J, Vacca M, Marrugat J, Elosua R, Pare C, Azqueta M, Sanz G. Long-lasting sport practice and lone atrial fibrillation. Eur Heart J. 2002 Mar;23(6):477-82. doi: 10.1053/euhj.2001.2802.
- Background: PubMed 16617223Hegbom F, Sire S, Heldal M, Orning OM, Stavem K, Gjesdal K. Short-term exercise training in patients with chronic atrial fibrillation: effects on exercise capacity, AV conduction, and quality of life. J Cardiopulm Rehabil. 2006 Jan-Feb;26(1):24-9. doi: 10.1097/00008483-200601000-00005.
- Background: PubMed 22137082Osbak PS, Mourier M, Kjaer A, Henriksen JH, Kofoed KF, Jensen GB. A randomized study of the effects of exercise training on patients with atrial fibrillation. Am Heart J. 2011 Dec;162(6):1080-7. doi: 10.1016/j.ahj.2011.09.013.
- Background: PubMed 20643803European Association of Cardiovascular Prevention and Rehabilitation Committee for Science Guidelines; EACPR; Corra U, Piepoli MF, Carre F, Heuschmann P, Hoffmann U, Verschuren M, Halcox J; Document Reviewers; Giannuzzi P, Saner H, Wood D, Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP. Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur Heart J. 2010 Aug;31(16):1967-74. doi: 10.1093/eurheartj/ehq236. Epub 2010 Jul 19.
- Background: PubMed 18694656Du H, Newton PJ, Salamonson Y, Carrieri-Kohlman VL, Davidson PM. A review of the six-minute walk test: its implication as a self-administered assessment tool. Eur J Cardiovasc Nurs. 2009 Mar;8(1):2-8. doi: 10.1016/j.ejcnurse.2008.07.001. Epub 2008 Aug 9.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Marni Joensen, MD, PhD principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation and Standard treatment in people with Atrial Fibrillation, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life measurement (AFEQT score) from baseline to 3, 6 and 12 months (time frame: Inclusion and at 3, 6 and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03035539, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.