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Trial record 1 of 911 for:    "Heart Defects, Congenital"
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Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00436098
First Posted: February 16, 2007
Last Update Posted: August 27, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Lehrstuhl für Präventive und Rehabilitative Sportmedizin der TU Muenchen
Kuratorium für Prävention und Rehabilitation an der TU Muenchen
Information provided by:
Deutsches Herzzentrum Muenchen
  Purpose
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.

Condition Intervention
Heart Defects, Congenital Behavioral: Motorpedagogic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Activity: triaxial accelerometry [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • coordinative test: MOT 4-6 [ Time Frame: 3 months ]
  • coordinative test: LOS KF 18 [ Time Frame: 3 months ]
  • Quality of life: Kiddy-KINDL [ Time Frame: 3 months ]

Estimated Enrollment: 60
Study Start Date: February 2007
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
physical training
Behavioral: Motorpedagogic exercise
physical training
No Intervention: 2

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436098


Contacts
Contact: Alfred Hager, MD +49-89-1218 ext 1650 a-hager@web.de
Contact: Milka Pringsheim, MD +49-89-1218 ext 1301 pringsheim@dhm.mhn.de

Locations
Germany
Deutsches Herzzentrum Muenchen Recruiting
Munich, Germany, D-80636
Sub-Investigator: Milka Pringsheim, MD         
Kuratorium für Prävention und Rehabilitation der TU München Recruiting
Munich, Germany, D-80809
Contact: Christoph Lammel, PhD    +49-89-289 ext 24420    kuratorium.pr@sport.med.tum.de   
Sub-Investigator: Christoph Lammel, PhD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Lehrstuhl für Präventive und Rehabilitative Sportmedizin der TU Muenchen
Kuratorium für Prävention und Rehabilitation an der TU Muenchen
Investigators
Principal Investigator: Alfred Hager, MD Deutsches Herzzentrum München
  More Information

Responsible Party: Dr. A Hager, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier: NCT00436098     History of Changes
Other Study ID Numbers: GE IDE No. H00107
First Submitted: February 15, 2007
First Posted: February 16, 2007
Last Update Posted: August 27, 2008
Last Verified: August 2008

Keywords provided by Deutsches Herzzentrum Muenchen:
congenital heart disease
exercise training
motorpedagogical exercise
children
CHD: hemodynamically not significant defects
CHD: acyanotic defects after repair
CHD: cyanotic defects after repair

Additional relevant MeSH terms:
Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases