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Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)

NCT ID: NCT00436098

Last Updated: 2008-08-27

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-05-31

Brief Summary

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Children with congenital heart defects have shown to develop motor coordinative deficiencies. In this study we want to show that a motor pedagogic physical training can improve the coordinative capabilities of children aged 4-6 years.

Detailed Description

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The study will be performed with a randomized crossover design. After the first assessment of coordinative capabilities children were randomized into two groups. One starts with exercised training for three months. After midterm assessment of the capabilities they will pause for another 3 months and reassessed. The second group will start without training for the first three months. After midterm assessment they will train for three months and have their final assessment.

Conditions

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Heart Defects, Congenital

Keywords

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congenital heart disease exercise training motorpedagogical exercise children CHD: hemodynamically not significant defects CHD: acyanotic defects after repair CHD: cyanotic defects after repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

physical training

Group Type EXPERIMENTAL

Motorpedagogic exercise

Intervention Type BEHAVIORAL

physical training

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Motorpedagogic exercise

physical training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* without significant residuals hemodynamically not significant
* without significant residuals after repair
* age 4-6 incl.

Exclusion Criteria

* gradient at coarctation site \> 20 mmHg
* gradient RVOT, PV, LVOT, or AoV \> 30 mmHg
* right-left shunt (rest or exercise)
* left-right shunt with dilatation or failure of ana cardiac chamber
* pulmonary hypertension
* heart failure, necessitating therapy
* (suspected) myocarditis or cardiomyopathy
* significant arrhythmia
* ion channel defects, other arrhythmic diseases
* Fontan-like circulation
* repair by atrial switch
* oral anticoagulation
* other medical problems curtailing exercise capacity
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lehrstuhl für Präventive und Rehabilitative Sportmedizin der TU Muenchen

UNKNOWN

Sponsor Role collaborator

Kuratorium für Prävention und Rehabilitation an der TU Muenchen

UNKNOWN

Sponsor Role collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Deutsches Herzzentrum Munich

Principal Investigators

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Alfred Hager, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München

Locations

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Deutsches Herzzentrum Muenchen

Munich, , Germany

Site Status RECRUITING

Kuratorium für Prävention und Rehabilitation der TU München

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Alfred Hager, MD

Role: CONTACT

Phone: +49-89-1218

Email: [email protected]

Milka Pringsheim, MD

Role: CONTACT

Phone: +49-89-1218

Email: [email protected]

Facility Contacts

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Christoph Lammel, PhD

Role: primary

Other Identifiers

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GE IDE No. H00107

Identifier Type: -

Identifier Source: org_study_id