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Exercise in Patients With a Biventricular Pacemaker

Primary Purpose

Left Ventricular Failure

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Endurance exercise
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Left Ventricular Failure focused on measuring Left ventricular failure, chronic heart failure, Pacemaker, Resynchronisation therapy, Exercise, Endurance exercise

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximal oxygen uptake (VO2max)

Secondary Outcome Measures

Body mass index (BMI)
Brain natriuretic peptide (BNP)
Body composition
Mood

Full Information

First Posted
May 19, 2009
Last Updated
December 21, 2009
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00905944
Brief Title
Exercise in Patients With a Biventricular Pacemaker
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Failure
Keywords
Left ventricular failure, chronic heart failure, Pacemaker, Resynchronisation therapy, Exercise, Endurance exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Endurance exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal oxygen uptake (VO2max)
Time Frame
At recruitment and after 12 weeks
Secondary Outcome Measure Information:
Title
Body mass index (BMI)
Time Frame
At recruitment and after 12 weeks
Title
Brain natriuretic peptide (BNP)
Time Frame
At recruitment and after 12 weeks
Title
Body composition
Time Frame
At recruitment and after 12 weeks
Title
Mood
Time Frame
At recruitment and after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Dimeo, MD
Phone
+493084452098
Email
fernando.dimeo@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Dimeo, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Dimeo, MD
Phone
+493084452098
Email
fernando.dimeo@charite.de

12. IPD Sharing Statement

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Exercise in Patients With a Biventricular Pacemaker

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