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Clinical Trials/NCT00905944
NCT00905944UnknownPhase 2

Effects of an Exercise Program on the Tendance to Severe Arrhythmias in Patients With Severely Impaired Left Ventricular Function and Cardial Re-synchronisation Therapy

Charite University, Berlin, Germany2 sites in 1 country45 target enrollmentStarted: December 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Enrollment
45
Locations
2
Primary Endpoint
Maximal oxygen uptake (VO2max)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

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

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Maximal oxygen uptake (VO2max)

Time Frame: At recruitment and after 12 weeks

Secondary Outcomes

  • Body mass index (BMI)(At recruitment and after 12 weeks)
  • Brain natriuretic peptide (BNP)(At recruitment and after 12 weeks)
  • Body composition(At recruitment and after 12 weeks)
  • Mood(At recruitment and after 12 weeks)

Investigators

Sponsor Class
Other

Study Sites (2)

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