Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
Lehrstuhl für Präventive und Rehabilitative Sportmedizin der TU Muenchen
Kuratorium für Prävention und Rehabilitation an der TU Muenchen
Information provided by:
Deutsches Herzzentrum Muenchen Identifier:
First received: February 15, 2007
Last updated: August 26, 2008
Last verified: August 2008
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:

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

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00436098

Deutsches Herzzentrum Muenchen
Munich, Germany, D-80636
Kuratorium für Prävention und Rehabilitation der TU München
Munich, Germany, D-80809
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Lehrstuhl für Präventive und Rehabilitative Sportmedizin der TU Muenchen
Kuratorium für Prävention und Rehabilitation an der TU Muenchen
Principal Investigator: Alfred Hager, MD Deutsches Herzzentrum München
  More Information

Responsible Party: Dr. A Hager, Deutsches Herzzentrum Munich 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
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 processed this record on January 14, 2017