NCT00860678

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
Last Updated

March 12, 2009

Status Verified

March 1, 2009

First QC Date

March 11, 2009

Last Update Submit

March 11, 2009

Conditions

Valvular Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

  • Maximum oxygen uptake

Study Arms (2)

A

ACTIVE COMPARATOR

Training group

Other: Physical activity

B

OTHER

Controls

Other: no Intervention

Interventions

Physical activityOTHER
A
no InterventionOTHER
B

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with severe valvular aortic stenosis and indication for valve replacement

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Prevention and Sports Medicine Technische Universität München

München, Bavaria, 80802, Germany

Location

Related Publications (1)

  • 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.

    PMID: 33962483DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Last Updated

March 12, 2009

Record last verified: 2009-03

Locations

DE(1)