Study of the Effect of Exercise Training on Patients in Atrial Fibrillation

This study has been completed.
Sponsor:
Collaborators:
Hvidovre University Hospital
University of Copenhagen
Information provided by:
Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT01367197
First received: June 1, 2011
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Behavioral: exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Study of the Effect of Exercise Training on Patients in Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital, Hvidovre:

Primary Outcome Measures:
  • cardiac output [ Time Frame: participants will be followed for the duration of the intervention, an average of 12 weeks ] [ Designated as safety issue: No ]
    participants will be followed for the duration of the intervention, an average of 12 weeks

  • Quality of life [ Time Frame: participants will be followed for the duration of the intervention, an average of 12 weeks ] [ Designated as safety issue: No ]
    participants will be followed for the duration of the intervention, an average of 12 weeks

  • exercise capacity [ Time Frame: participants will be followed for the duration of the intervention, an average of 12 weeks ] [ Designated as safety issue: No ]
    participants will be followed for the duration of the intervention, an average of 12 weeks


Secondary Outcome Measures:
  • muscle strength [ Time Frame: participants will be followed for the duration of the intervention, an average of 12 weeks ] [ Designated as safety issue: No ]
    participants will be followed for the duration of the intervention, an average of 12 weeks

  • biomarkers ANB, BNP [ Time Frame: participants will be followed for the duration of the intervention, an average of 12 weeks ] [ Designated as safety issue: No ]
    participants will be followed for the duration of the intervention, an average of 12 weeks

  • Body composition DEXA-scan [ Time Frame: participants will be followed for the duration of the intervention, an average of 12 weeks ] [ Designated as safety issue: No ]
    participants will be followed for the duration of the intervention, an average of 12 weeks


Enrollment: 49
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No intervention
Observation only
Experimental: Exercise training group
Group exercise training, three times weekly high-intensity
Behavioral: exercise training
group based exercise training

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367197

Locations
Denmark
Hvidovre Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Hvidovre University Hospital
University of Copenhagen
Investigators
Principal Investigator: Philip S Osbak, MD Hvidovre Hospital, Denmark
  More Information

Additional Information:
No publications provided

Responsible Party: Philip Osbak, MD, Hvidovre Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01367197     History of Changes
Other Study ID Numbers: 22300240
Study First Received: June 1, 2011
Last Updated: June 3, 2011
Health Authority: Denmark: National Board of Health
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Copenhagen University Hospital, Hvidovre:
exercise training
atrial fibrillation

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

ClinicalTrials.gov processed this record on August 21, 2014