Clinical trial NCT03035539: Rehabilitation of Patients With Atrial Fibrillation
Official title: Rehabilitation of Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Rehabilitation
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Paroxysmal or persistent atrial fibrillation
* Signed informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Quality of life measurement (AFEQT score) from baseline to 3, 6 and 12 months
timeFrame: Inclusion and at 3, 6 and 12 months
measure: Change in Quality of life measurement (AF-QoL 18 score) from baseline to 3, 6 and 12 months
timeFrame: Inclusion and at 3, 6 and 12 months
measure: Change in Quality of life measurement (GAD7 score) from baseline to 3, 6 and 12 months
timeFrame: Inclusion and at 3, 6 and 12 months
measure: Change in Quality of life measurement (PHQ-9 score) from baseline to 3, 6 and 12 months
timeFrame: Inclusion and at 3, 6 and 12 months
Secondary outcomes:
measure: Morbidity
timeFrame: 12 months follow-up
measure: Health Economics (Cost-effectiveness analysis)
timeFrame: 12 months follow-up
measure: Change in maximum exercise capacity (calculated oxygen uptake) from baseline to 3 and 6 months
timeFrame: Inclusion and at 3 and 6 months follow up
measure: Change in 6 minute walk test from baseline to 3 and 6 months
timeFrame: Inclusion and at 3 and 6 months follow up
measure: Change in 5-repetition-sit-to-stand-test from baseline to 3 and 6 months
timeFrame: Inclusion and at 3 and 6 months follow up
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Albert Marni Joensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Stewart 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.
citation: Hylek 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.
citation: Savelieva 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.
citation: Anand 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.
citation: Aizer 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.
citation: Mozaffarian 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.
citation: Mont 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.
citation: Hegbom 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.
citation: Osbak 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.
citation: European 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.
citation: Du 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.
citation: Bohannon 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.
citation: Arribas 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.
citation: Spertus 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.
citation: EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
citation: Goldsmith KA, Dyer MT, Buxton MJ, Sharples LD. Mapping of the EQ-5D index from clinical outcome measures and demographic variables in patients with coronary heart disease. Health Qual Life Outcomes. 2010 Jun 4;8:54. doi: 10.1186/1477-7525-8-54.
citation: Dyer MT, Goldsmith KA, Sharples LS, Buxton MJ. A review of health utilities using the EQ-5D in studies of cardiovascular disease. Health Qual Life Outcomes. 2010 Jan 28;8:13. doi: 10.1186/1477-7525-8-13.
citation: Brazier JE, Yang Y, Tsuchiya A, Rowen DL. A review of studies mapping (or cross walking) non-preference based measures of health to generic preference-based measures. Eur J Health Econ. 2010 Apr;11(2):215-25. doi: 10.1007/s10198-009-0168-z. Epub 2009 Jul 8.
citation: Badia X, Arribas F, Ormaetxe JM, Peinado R, de Los Terreros MS. Development of a questionnaire to measure health-related quality of life (HRQoL) in patients with atrial fibrillation (AF-QoL). Health Qual Life Outcomes. 2007 Jul 4;5:37. doi: 10.1186/1477-7525-5-37.
citation: Wittrup-Jensen KU, Lauridsen J, Gudex C, Pedersen KM. Generation of a Danish TTO value set for EQ-5D health states. Scand J Public Health. 2009 Jul;37(5):459-66. doi: 10.1177/1403494809105287. Epub 2009 May 1.