Clinical trial NCT01367197: 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
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: exercise training
atrial fibrillation
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
name: University of Copenhagen
First posted: 2011-06-07
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: cardiac output
timeFrame: participants will be followed for the duration of the intervention, an average of 12 weeks
measure: Quality of life
timeFrame: participants will be followed for the duration of the intervention, an average of 12 weeks
measure: exercise capacity
timeFrame: participants will be followed for the duration of the intervention, an average of 12 weeks
Secondary outcomes:
measure: muscle strength
timeFrame: participants will be followed for the duration of the intervention, an average of 12 weeks
measure: biomarkers ANB, BNP
timeFrame: participants will be followed for the duration of the intervention, an average of 12 weeks
measure: Body composition DEXA-scan
timeFrame: participants will be followed for the duration of the intervention, an average of 12 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
state: Hvidovre
Study officials:
affiliation: Hvidovre University Hospital
name: Philip S Osbak, MD
role: PRINCIPAL_INVESTIGATOR
References: