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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Recruiting
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00436098
First received: February 15, 2007
Last updated: August 26, 2008
Last verified: August 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Activity: triaxial accelerometry [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • coordinative test: MOT 4-6 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • coordinative test: LOS KF 18 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Quality of life: Kiddy-KINDL [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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
n/a

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

Ages Eligible for Study:   4 Years to 7 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. A Hager, Deutsches Herzzentrum Munich
ClinicalTrials.gov Identifier: NCT00436098     History of Changes
Other Study ID Numbers: GE IDE No. H00107
Study First Received: February 15, 2007
Last Updated: August 26, 2008
Health Authority: Germany: Ethics Commission

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:
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 23, 2013