Back to resultsPhysical Activity in Patients After Aortic Valve Replacement (Valve-ex)
Primary Purpose
Valvular Aortic Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Physical activity
no Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Valvular Aortic Stenosis
Eligibility Criteria
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)
Sites / Locations
- Department of Prevention and Sports Medicine Technische Universität München
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
A
B
Arm Description
Training group
Controls
Outcomes
Primary Outcome Measures
Maximum oxygen uptake
Secondary Outcome Measures
Full Information
NCT ID
NCT00860678
First Posted
March 11, 2009
Last Updated
March 11, 2009
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00860678
Brief Title
Physical Activity in Patients After Aortic Valve Replacement (Valve-ex)
Official Title
Influence of Regular Physical Activity on Exercise Capacity, Cardiac Remodeling and Endothelial Function in Patients After Aortic Valve Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Technical University of Munich
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Aortic Stenosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Training group
Arm Title
B
Arm Type
Other
Arm Description
Controls
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Type
Other
Intervention Name(s)
no Intervention
Primary Outcome Measure Information:
Title
Maximum oxygen uptake
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Department of Prevention and Sports Medicine Technische Universität München
City
München
State/Province
Bavaria
ZIP/Postal Code
80802
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33962483
Citation
Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
Results Reference
derived
Learn more about this trial
Physical Activity in Patients After Aortic Valve Replacement (Valve-ex)
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