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

NCT01367197 | Completed

• 1 other identifier: 22300240
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Keywords

exercise training; atrial fibrillation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• muscle strength

  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

• Body composition DEXA-scan

  participants will be followed for the duration of the intervention, an average of 12 weeks

Study Arms (2)

No intervention

NO INTERVENTION

Observation only

Exercise training group

EXPERIMENTAL

Group exercise training, three times weekly high-intensity

Behavioral: exercise training

Interventions

exercise training BEHAVIORAL

group based exercise training

Exercise training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre: lead
• Hvidovre University Hospital: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Hvidovre Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Philip S Osbak, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 7, 2011
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 7, 2011

Record last verified: 2011-06

Locations

DK (1)