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Rehabilitation of Patients With Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cardiac rehabilitation
Standard treatment
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Rehabilitation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard treatment

Cardiac Rehabilitation

Arm Description

Standard treatment after randomization

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

Outcomes

Primary Outcome Measures

Change in Quality of life measurement (AFEQT score) from baseline to 3, 6 and 12 months
Change in Quality of life measurement (AF-QoL 18 score) from baseline to 3, 6 and 12 months
Change in Quality of life measurement (GAD7 score) from baseline to 3, 6 and 12 months
Change in Quality of life measurement (PHQ-9 score) from baseline to 3, 6 and 12 months

Secondary Outcome Measures

Morbidity
Health Economics (Cost-effectiveness analysis)
Evaluated by - EQ-5
Change in maximum exercise capacity (calculated oxygen uptake) from baseline to 3 and 6 months
Change in 6 minute walk test from baseline to 3 and 6 months
Change in 5-repetition-sit-to-stand-test from baseline to 3 and 6 months

Full Information

First Posted
July 13, 2012
Last Updated
July 14, 2017
Sponsor
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03035539
Brief Title
Rehabilitation of Patients With Atrial Fibrillation
Official Title
Rehabilitation of Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Physiotherapists evaluating the physical capacity were masked.
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Standard treatment after randomization
Arm Title
Cardiac Rehabilitation
Arm Type
Experimental
Arm Description
The rehabilitation programme includes education, physical exercise, optimisation of the medical treatment, and discussion of implications for the daily life of each participant.
Intervention Type
Other
Intervention Name(s)
Cardiac rehabilitation
Intervention Description
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
Intervention Name(s)
Standard treatment
Intervention Description
Standard treatment
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
12 months follow-up
Title
Health Economics (Cost-effectiveness analysis)
Description
Evaluated by - EQ-5
Time Frame
12 months follow-up
Title
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
Title
Change in 6 minute walk test from baseline to 3 and 6 months
Time Frame
Inclusion and at 3 and 6 months follow up
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Marni Joensen, MD, PhD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
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Rehabilitation of Patients With Atrial Fibrillation

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