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Completed

NCT Number: NCT01367197

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre Hospital

Copenhagen, Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training

Behavioral

group based exercise training

Primary outcomes

  1. cardiac output

    Time frame: 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

  2. Quality of life

    Time frame: 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

  3. exercise capacity

    Time frame: 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

  1. muscle strength

    Time frame: 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

  2. biomarkers ANB, BNP

    Time frame: 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

  3. Body composition DEXA-scan

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Collaborators

  • Hvidovre University Hospital
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jun 7, 2011
Registry last updated
Jun 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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