NCT00934609

Brief Summary

The study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure

Trial Health

80
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

First QC Date

July 7, 2009

Last Update Submit

September 17, 2009

Conditions

Dilated CardiomyopathyChronic Heart Failure

Keywords

Exerciseheart failuredilated cardiomyopathyEndurance training

Outcome Measures

Primary Outcomes (1)

  • Physical capacity

Secondary Outcomes (2)

  • Left ventricular function

  • occurence of complications

    within study period

Study Arms (2)

Training

EXPERIMENTAL

12 weeks of endurance training on the cycle ergometer under supervision on a physician

Behavioral: Endurance training

Control

NO INTERVENTION

Control condition

Interventions

Endurance trainingBEHAVIORAL

45 min ergometer cycling at the ventilatory anaerobic threshold 4 times per week for 12 weeks

Training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic heart failure NYHA stage 2 and 3

You may not qualify if:

  • Valvular disease
  • recent decompensation
  • Other complaints that might interfere with ergometer exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports- and Preventive Medicine, Saarland University

Saarbrücken, Saarland, 66123, Germany

Location

MeSH Terms

Conditions

Cardiomyopathy, DilatedMotor ActivityHeart Failure

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 8, 2009

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

DE(1)