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

NCT ID: NCT00860678

Last Updated: 2009-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Valvular Aortic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Training group

Group Type ACTIVE_COMPARATOR

Physical activity

Intervention Type OTHER

B

Controls

Group Type OTHER

no Intervention

Intervention Type OTHER

Interventions

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Physical activity

Intervention Type OTHER

no Intervention

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Locations

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Department of Prevention and Sports Medicine Technische Universität München

München, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 33962483 (View on PubMed)

Other Identifiers

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2152/08

Identifier Type: -

Identifier Source: org_study_id

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