We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise in Patients With a Biventricular Pacemaker

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.
ClinicalTrials.gov Identifier: NCT00905944
Recruitment Status : Unknown
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : May 21, 2009
Last Update Posted : December 23, 2009
Sponsor:
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
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 or disease Intervention/treatment Phase
Left Ventricular Failure Other: Endurance exercise Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : December 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



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

Secondary Outcome Measures :
  1. Body mass index (BMI) [ Time Frame: At recruitment and after 12 weeks ]
  2. Brain natriuretic peptide (BNP) [ Time Frame: At recruitment and after 12 weeks ]
  3. Body composition [ Time Frame: At recruitment and after 12 weeks ]
  4. Mood [ Time Frame: At recruitment and after 12 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

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