Rehabilitation of Patients With Atrial Fibrillation

NCT ID: NCT03035539

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-04-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard treatment

Standard treatment after randomization

Group Type: ACTIVE_COMPARATOR

Standard treatment

Intervention Type: OTHER

Standard treatment

Cardiac Rehabilitation

The rehabilitation programme includes education, physical exercise, optimisation of the medical treatment, and discussion of implications for the daily life of each participant.

Group Type: EXPERIMENTAL

Cardiac rehabilitation

Intervention Type: OTHER

AF specific cardiac rehabilitation Group education 1 hour each week for 3 months Physical training 1 hour each week for 3 months with physiotherapist

Interventions

Cardiac rehabilitation

AF specific cardiac rehabilitation Group education 1 hour each week for 3 months Physical training 1 hour each week for 3 months with physiotherapist

Intervention Type: OTHER

Standard treatment

Standard treatment

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Albert Marni Joensen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albert Marni Joensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

Aalborg Hospital

Aalborg, , Denmark

Countries

Denmark

References

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Other Identifiers

N-20120002

Identifier Type: -

Identifier Source: org_study_id