- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00934609
Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure (CHF)
September 17, 2009 updated by: Universität des Saarlandes
Effects of 12-weeks Endurance Training in Patients With Chronic Heart Failure Due to Dilated Cardiomyopathy
The study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
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
-
-
Saarland
-
Saarbrücken, Saarland, Germany, 66123
- Institute of Sports- and Preventive Medicine, Saarland University
-
-
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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronic heart failure NYHA stage 2 and 3
Exclusion Criteria:
- Valvular disease
- recent decompensation
- Other complaints that might interfere with ergometer exercise
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training
12 weeks of endurance training on the cycle ergometer under supervision on a physician
|
45 min ergometer cycling at the ventilatory anaerobic threshold 4 times per week for 12 weeks
|
|
No Intervention: Control
Control condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Physical capacity
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Left ventricular function
|
|
|
occurence of complications
Time Frame: within study period
|
within study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 Registration Dates
First Submitted
July 7, 2009
First Submitted That Met QC Criteria
July 7, 2009
First Posted (Estimate)
July 8, 2009
Study Record Updates
Last Update Posted (Estimate)
September 18, 2009
Last Update Submitted That Met QC Criteria
September 17, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000-01SaarlandU
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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