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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
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: May 19, 2009
Last updated: December 21, 2009
Last verified: December 2009
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.

Condition Intervention Phase
Left Ventricular Failure
Other: Endurance exercise
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Maximal oxygen uptake (VO2max) [ Time Frame: At recruitment and after 12 weeks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: December 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00905944

Contact: Fernando Dimeo, MD +493084452098

Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30 Recruiting
Berlin, Germany, 12200
Contact: Fernando Dimeo, MD    +493084452098   
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Fernando Dimeo, MD Charite University, Berlin, Germany
  More Information

Responsible Party: Dr. Fernando Dimeo, Dept. of Sports Medicine, Charité Universitätsmedizin Berlin Identifier: NCT00905944     History of Changes
Other Study ID Numbers: EA4/063/07
Study First Received: May 19, 2009
Last Updated: December 21, 2009

Keywords provided by Charite University, Berlin, Germany:
Left ventricular failure
chronic heart failure
Resynchronisation therapy
Endurance exercise

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on May 25, 2017