Brief Summary

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Official Title: "Effects of an Exercise Program on the Tendance to Severe Arrhythmias in Patients With Severely Impaired Left Ventricular Function and Cardial Re-synchronisation Therapy"

The investigators will evaluate the effects of an exercise program (walking on a treadmill) on the physical performance, the cardiorespiratory function, the proclivity to heart arrhythmias and the quality of life of patients with severely impaired left ventricular function and a bi-ventricular resynchronization pacemaker.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Study Primary Completion Date: December 2009

Interventions Used in this Clinical Trial

• Other: Endurance exercise
  • The patients carry out an exercise program (walking on a treadmill) three times weekly for 12 weeks at a speed corresponding with an intensity of 70% of VO2max.

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: Control
• Experimental: Intervention
  • The patients carry out an exercise program (walking on a treadmill) three times weekly for 12 weeks at a speed corresponding with an intensity of 70% of VO2max.

Outcome Measures for this Clinical Trial

Primary Measures

• Maximal oxygen uptake (VO2max)
  • Time Frame: At recruitment and after 12 weeks
    Safety Issue?: No

Secondary Measures

• Body mass index (BMI)
  • Time Frame: At recruitment and after 12 weeks
    Safety Issue?: No
• Brain natriuretic peptide (BNP)
  • Time Frame: At recruitment and after 12 weeks
    Safety Issue?: Yes
• Body composition
  • Time Frame: At recruitment and after 12 weeks
    Safety Issue?: Yes
• Mood
  • Time Frame: At recruitment and after 12 weeks
    Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Left ventricular failure
• Resynchronization therapy with a biventricular pacemaker
• Ability to understand written German

Exclusion Criteria

• Age over 75 years
• Severe cardiac arrhythmia
• All conditions which can be aggravated by an exercise program

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Charite University, Berlin, Germany
• Provider of Information About this Clinical Study
  • Dr. Fernando Dimeo, Dept. of Sports Medicine, Charité Universitätsmedizin Berlin
• Overall Official(s)
  • Fernando Dimeo, MD, Principal Investigator, Charite University, Berlin, Germany
• Overall Contact(s)
  • Fernando Dimeo, MD, +493084452098, fernando.dimeo@charite.de