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Exercise in Patients With a Biventricular Pacemaker

NCT ID: NCT00905944

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Left Ventricular Failure

Keywords

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Left ventricular failure chronic heart failure Pacemaker Resynchronisation therapy Exercise Endurance exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Endurance exercise

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Dept. of Sports Medicine, Charité Universitätsmedizin Berlin

Principal Investigators

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Fernando Dimeo, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Fernando Dimeo, MD

Role: CONTACT

Phone: +493084452098

Email: [email protected]

Facility Contacts

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Fernando Dimeo, MD

Role: primary

Other Identifiers

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EA4/063/07

Identifier Type: -

Identifier Source: org_study_id