Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring exercise training, atrial fibrillation
Eligibility Criteria
Inclusion Criteria:
- Adult subjects in permanent atrial fibrillation, willing to participate in a 12 weeks training program and able to give informed consent to participation were eligible for the study.
Exclusion Criteria:
- Subjects with severe refractory hypertension
- previous heart valve surgery, moderate to severe COPD
- restrictive lung disease, moderate to severe asthma
- pregnant or lactating subjects
- patients with a very low life expectancy
- patients who were unable to exercise or comply with the study protocol
Sites / Locations
- Hvidovre Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No intervention
Exercise training group
Arm Description
Observation only
Group exercise training, three times weekly high-intensity
Outcomes
Primary Outcome Measures
cardiac output
participants will be followed for the duration of the intervention, an average of 12 weeks
Quality of life
participants will be followed for the duration of the intervention, an average of 12 weeks
exercise capacity
participants will be followed for the duration of the intervention, an average of 12 weeks
Secondary Outcome Measures
muscle strength
participants will be followed for the duration of the intervention, an average of 12 weeks
biomarkers ANB, BNP
participants will be followed for the duration of the intervention, an average of 12 weeks
Body composition DEXA-scan
participants will be followed for the duration of the intervention, an average of 12 weeks
Full Information
NCT ID
NCT01367197
First Posted
June 1, 2011
Last Updated
June 3, 2011
Sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
Hvidovre University Hospital, University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01367197
Brief Title
Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
Official Title
Randomised Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
Hvidovre University Hospital, University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
PURPOSE Physical exercise is beneficial for patients with ischemic heart disease and chronic heart failure, while little is known about the effect in atrial fibrillation (AF). The investigators studied the effect of physical exercise on cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF in a randomised study of physical exercise training three times weekly for twelve weeks.
HYPOTHESIS Exercise training improves cardiac output (CO), max. exercise capacity, biomarkers and quality of life (Qol) in patients with AF.
METHODS Assessment of exercise capacity, CO, Qol, body composition, six minute walk test and muscular strength was performed before and after 12 weeks.
Resting echocardiography was done at baseline. CO was measured using impedance cardiography at rest and during maximal exercise testing on an ergometer bicycle. Body composition, muscular strength and six minutes walking capacity were measured before and after the training period. Qol was evaluated by the use of the standardized validated questionnaires Short Form 36 (SF-36) and the Minnesota Living with Heart Failure Questionnaire (MLHF-Q).
Training consisted of aerobic exercise at 70 percent of max. capacity estimated by Borg-scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
exercise training, atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Observation only
Arm Title
Exercise training group
Arm Type
Experimental
Arm Description
Group exercise training, three times weekly high-intensity
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Intervention Description
group based exercise training
Primary Outcome Measure Information:
Title
cardiac output
Description
participants will be followed for the duration of the intervention, an average of 12 weeks
Time Frame
participants will be followed for the duration of the intervention, an average of 12 weeks
Title
Quality of life
Description
participants will be followed for the duration of the intervention, an average of 12 weeks
Time Frame
participants will be followed for the duration of the intervention, an average of 12 weeks
Title
exercise capacity
Description
participants will be followed for the duration of the intervention, an average of 12 weeks
Time Frame
participants will be followed for the duration of the intervention, an average of 12 weeks
Secondary Outcome Measure Information:
Title
muscle strength
Description
participants will be followed for the duration of the intervention, an average of 12 weeks
Time Frame
participants will be followed for the duration of the intervention, an average of 12 weeks
Title
biomarkers ANB, BNP
Description
participants will be followed for the duration of the intervention, an average of 12 weeks
Time Frame
participants will be followed for the duration of the intervention, an average of 12 weeks
Title
Body composition DEXA-scan
Description
participants will be followed for the duration of the intervention, an average of 12 weeks
Time Frame
participants will be followed for the duration of the intervention, an average of 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects in permanent atrial fibrillation, willing to participate in a 12 weeks training program and able to give informed consent to participation were eligible for the study.
Exclusion Criteria:
Subjects with severe refractory hypertension
previous heart valve surgery, moderate to severe COPD
restrictive lung disease, moderate to severe asthma
pregnant or lactating subjects
patients with a very low life expectancy
patients who were unable to exercise or comply with the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip S Osbak, MD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre Hospital
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://nafi.dk/normal/?menu_id=49&page_id=12
Description
Danish atrial fibrillation research group
Learn more about this trial
Study of the Effect of Exercise Training on Patients in Atrial Fibrillation
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