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Exercise in Patients With a Biventricular Pacemaker

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905944
First Posted: May 21, 2009
Last Update Posted: December 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
May 19, 2009
May 21, 2009
December 23, 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 ]
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 ]
  • Brain natriuretic peptide (BNP) [ Time Frame: At recruitment and after 12 weeks ]
  • Body composition [ Time Frame: At recruitment and after 12 weeks ]
  • Mood [ Time Frame: At recruitment and after 12 weeks ]
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
Intervention Model: Crossover Assignment
Masking: Single (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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00905944
EA4/063/07
No
Not Provided
Not Provided
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
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