NCT00905944

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

Same day

First QC Date

May 19, 2009

Last Update Submit

December 21, 2009

Conditions

Left Ventricular Failure

Keywords

Left ventricular failurechronic heart failurePacemakerResynchronisation therapyExerciseEndurance exercise

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen uptake (VO2max)

    At recruitment and after 12 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL

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

Interventions

Endurance exerciseOTHER

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Left ventricular failure
  • Resynchronization therapy with a biventricular pacemaker
  • Ability to understand written German

You may not qualify if:

  • Age over 75 years
  • Severe cardiac arrhythmia
  • All conditions which can be aggravated by an exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30

Berlin, State of Berlin, 12200, Germany

RECRUITING

MeSH Terms

Conditions

Heart FailureMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Fernando Dimeo, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Dimeo, MD

CONTACT

+493084452098fernando.dimeo@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

DE(1)