Exercise in Patients With a Biventricular Pacemaker

Left Ventricular Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00905944
• Other study ID #: EA4/063/07
• 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

• Heart Failure
• Left Ventricular Failure

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