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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367197
• Other study ID #: 22300240
• Status: Completed
• Phase: N/A
• First received: June 1, 2011
• Last updated: June 3, 2011
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• exercise training
group based exercise training

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Copenhagen	Hvidovre

Sponsors (3)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre	Hvidovre University Hospital, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Danish atrial fibrillation research group