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Rehabilitation of Patients With Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03035539
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Albert Marni Joensen, Aalborg University Hospital

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Cardiac rehabilitation Other: Standard treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Physiotherapists evaluating the physical capacity were masked.
Primary Purpose: Treatment
Official Title: Rehabilitation of Patients With Atrial Fibrillation
Study Start Date : May 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard treatment
Standard treatment after randomization
Other: Standard treatment
Standard treatment

Experimental: 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.
Other: 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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 Measures :
  1. Morbidity [ Time Frame: 12 months follow-up ]
  2. Health Economics (Cost-effectiveness analysis) [ Time Frame: 12 months follow-up ]

    Evaluated by

    - EQ-5


  3. 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 ]
  4. Change in 6 minute walk test from baseline to 3 and 6 months [ Time Frame: Inclusion and at 3 and 6 months follow up ]
  5. 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 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035539


Locations
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Denmark
Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Principal Investigator: Albert Marni Joensen, MD, PhD Aalborg University Hospital

Publications:

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Responsible Party: Albert Marni Joensen, MD, PhD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03035539     History of Changes
Other Study ID Numbers: N-20120002
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Albert Marni Joensen, Aalborg University Hospital:
Rehabilitation

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes