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

NCT ID: NCT01367197

Last Updated: 2011-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-06-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

No intervention

Observation only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise training group

Group exercise training, three times weekly high-intensity

Group Type: EXPERIMENTAL

exercise training

Intervention Type: BEHAVIORAL

group based exercise training

Interventions

exercise training

group based exercise training

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role: lead

Responsible Party

Hvidovre Hospital, Denmark

Principal Investigators

Philip S Osbak, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

Hvidovre Hospital

Copenhagen, Hvidovre, Denmark

Countries

Denmark

Other Identifiers

22300240

Identifier Type: -

Identifier Source: org_study_id