- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00860678
Physical Activity in Patients After Aortic Valve Replacement (Valve-ex)
March 11, 2009 updated by: Technical University of Munich
Influence of Regular Physical Activity on Exercise Capacity, Cardiac Remodeling and Endothelial Function in Patients After Aortic Valve Replacement
A structured and supervised, 3-month physical activity intervention in patients after aortic valve replacement due to severe stenosis, accompanied by examination of cardiac size and function, exercise capacity and endothelial function before, three and six months after operation; comparison with a non-intervention control group.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
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
-
-
Bavaria
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München, Bavaria, Germany, 80802
- Department of Prevention and Sports Medicine Technische Universität München
-
-
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
65 years to 75 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with severe valvular aortic stenosis and indication for valve replacement
Exclusion Criteria:
- Coronary heart disease with indication for additional bypass surgery Leading insufficiency of the valve
- Age < 65 or > 75
- Diseases or conditions leading to additional risks during physical activity (e.g. diabetes, arthrosis, obstructive pulmonary disease)
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Training group
|
|
Other: B
Controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Maximum oxygen uptake
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 11, 2009
First Submitted That Met QC Criteria
March 11, 2009
First Posted (Estimate)
March 12, 2009
Study Record Updates
Last Update Posted (Estimate)
March 12, 2009
Last Update Submitted That Met QC Criteria
March 11, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2152/08
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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-
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