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

• Sponsor: Technische Universität München (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00860678
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Valvular Aortic Stenosis	Other: Physical activity; Other: no Intervention	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Influence of Regular Physical Activity on Exercise Capacity, Cardiac Remodeling and Endothelial Function in Patients After Aortic Valve Replacement

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A Training group	Other: Physical activity
Other: B Controls	Other: no Intervention

Outcome Measures

Primary Outcome Measures

1. Maximum oxygen uptake []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Prevention and Sports Medicine Technische Universität München	München	Bavaria	Germany	80802

Sponsors and Collaborators

• Technische Universität München

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00860678
• Other Study ID Numbers: 2152/08
• First Posted: Mar 12, 2009
• Last Update Posted: Mar 12, 2009
• Last Verified: Mar 1, 2009

• Additional relevant MeSH terms: Aortic Valve Stenosis

Study Results

No Results Posted as of Mar 12, 2009