Exercise in Patients With a Biventricular Pacemaker

December 21, 2009 updated by: Charite University, Berlin, Germany

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Recruiting
        • Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal oxygen uptake (VO2max)
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body mass index (BMI)
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks
Brain natriuretic peptide (BNP)
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks
Body composition
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks
Mood
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 21, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4/063/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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