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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Behavioral: exercise training

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre
    • Copenhagen, Hvidovre, Denmark, 2650
      • Hvidovre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac output	participants will be followed for the duration of the intervention, an average of 12 weeks	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	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	participants will be followed for the duration of the intervention, an average of 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle strength	participants will be followed for the duration of the intervention, an average of 12 weeks	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	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	participants will be followed for the duration of the intervention, an average of 12 weeks

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre
• Collaborators: University of Copenhagen; Hvidovre University Hospital
• Investigators: Principal Investigator: Philip S Osbak, MD, Hvidovre University Hospital

Publications and helpful links

Helpful Links

• Danish atrial fibrillation research group

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Estimate): June 7, 2011
• Last Update Submitted That Met QC Criteria: June 3, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: atrial fibrillation; exercise training
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 22300240