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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
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905944

Contacts
Contact: Fernando Dimeo, MD +493084452098 fernando.dimeo@charite.de

Locations
Germany
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30 Recruiting
Berlin, Germany, 12200
Contact: Fernando Dimeo, MD     +493084452098     fernando.dimeo@charite.de    
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Fernando Dimeo, MD Charite University, Berlin, Germany
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013