Back to resultsTraining Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure (CHF)
Primary Purpose
Dilated Cardiomyopathy, Chronic Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Endurance training
Sponsored by
About this trial
This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring Exercise, heart failure, dilated cardiomyopathy, Endurance training
Eligibility Criteria
Inclusion Criteria:
- chronic heart failure NYHA stage 2 and 3
Exclusion Criteria:
- Valvular disease
- recent decompensation
- Other complaints that might interfere with ergometer exercise
Sites / Locations
- Institute of Sports- and Preventive Medicine, Saarland University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training
Control
Arm Description
12 weeks of endurance training on the cycle ergometer under supervision on a physician
Control condition
Outcomes
Primary Outcome Measures
Physical capacity
Secondary Outcome Measures
Left ventricular function
occurence of complications
Full Information
NCT ID
NCT00934609
First Posted
July 7, 2009
Last Updated
September 17, 2009
Sponsor
Universität des Saarlandes
Collaborators
The German Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00934609
Brief Title
Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure
Acronym
CHF
Official Title
Effects of 12-weeks Endurance Training in Patients With Chronic Heart Failure Due to Dilated Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Universität des Saarlandes
Collaborators
The German Heart Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy, Chronic Heart Failure
Keywords
Exercise, heart failure, dilated cardiomyopathy, Endurance training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Experimental
Arm Description
12 weeks of endurance training on the cycle ergometer under supervision on a physician
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control condition
Intervention Type
Behavioral
Intervention Name(s)
Endurance training
Intervention Description
45 min ergometer cycling at the ventilatory anaerobic threshold 4 times per week for 12 weeks
Primary Outcome Measure Information:
Title
Physical capacity
Secondary Outcome Measure Information:
Title
Left ventricular function
Title
occurence of complications
Time Frame
within study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic heart failure NYHA stage 2 and 3
Exclusion Criteria:
Valvular disease
recent decompensation
Other complaints that might interfere with ergometer exercise
Facility Information:
Facility Name
Institute of Sports- and Preventive Medicine, Saarland University
City
Saarbrücken
State/Province
Saarland
ZIP/Postal Code
66123
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure
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