Physical Activity in Patients After Aortic Valve Replacement (Valve-ex)

Valvular Aortic Stenosis Clinical Trial

Official title:

Influence of Regular Physical Activity on Exercise Capacity, Cardiac Remodeling and Endothelial Function in Patients After Aortic Valve Replacement

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00860678
• Other study ID #: 2152/08
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 11, 2009
• Last updated: March 11, 2009

Study information

• Verified date: March 2009
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Technische Universität München
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Valvular Aortic Stenosis

Intervention

Other:
• Physical activity

• no Intervention

Locations

Country	Name	City	State
Germany	Department of Prevention and Sports Medicine Technische Universität München	München	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum oxygen uptake