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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00905944
Other study ID # EA4/063/07
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received May 19, 2009
Last updated December 21, 2009
Start date December 2009
Est. completion date December 2009

Study information

Verified date December 2009
Source Charite University, Berlin, Germany
Contact Fernando Dimeo, MD
Phone +493084452098
Email fernando.dimeo@charite.de
Is FDA regulated No
Health authority Germany: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30 Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal oxygen uptake (VO2max) At recruitment and after 12 weeks No
Secondary Body mass index (BMI) At recruitment and after 12 weeks No
Secondary Brain natriuretic peptide (BNP) At recruitment and after 12 weeks Yes
Secondary Body composition At recruitment and after 12 weeks Yes
Secondary Mood At recruitment and after 12 weeks Yes
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Completed NCT01481298 - Value of Cardiac Magnetic Resonance (CMR) Derived Parameters for Diagnosing Left Ventricular Non-compaction Cardiomyopathy N/A
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