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Exercise in Patients With a Biventricular Pacemaker

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00905944
First received: May 19, 2009
Last updated: December 21, 2009
Last verified: December 2009
History of Changes

May 19, 2009
December 21, 2009
December 2009
December 2009   (final data collection date for primary outcome measure)
Maximal oxygen uptake (VO2max) [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00905944 on ClinicalTrials.gov Archive Site
  • Body mass index (BMI) [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: No ]
  • Brain natriuretic peptide (BNP) [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: Yes ]
  • Body composition [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: Yes ]
  • Mood [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Exercise in Patients With a Biventricular Pacemaker
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Left Ventricular Failure
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.
  • 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.
    Intervention: Other: Endurance exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Fernando Dimeo, MD +493084452098 fernando.dimeo@charite.de
Germany
 
NCT00905944
EA4/063/07
No
Dr. Fernando Dimeo, Dept. of Sports Medicine, Charité Universitätsmedizin Berlin
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Fernando Dimeo, MD Charite University, Berlin, Germany
Charite University, Berlin, Germany
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP