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

Heart Defects, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00436098
• Other study ID #: GE IDE No. H00107
• Status: Recruiting
• Phase: N/A
• First received: February 15, 2007
• Last updated: August 26, 2008
• Start date: February 2007
• Est. completion date: May 2010

Study information

• Verified date: August 2008
• Source: Deutsches Herzzentrum Muenchen
• Contact: Alfred Hager, MD
• Phone: +49-89-1218
• Email: a-hager[@]web.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 7 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

Behavioral:
• Motorpedagogic exercise
physical training

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	Kuratorium für Prävention und Rehabilitation der TU München	Munich

Sponsors (3)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Kuratorium für Prävention und Rehabilitation an der TU Muenchen, Lehrstuhl für Präventive und Rehabilitative Sportmedizin der TU Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity: triaxial accelerometry		3 months	No
Secondary	coordinative test: MOT 4-6		3 months	No
Secondary	coordinative test: LOS KF 18		3 months	No
Secondary	Quality of life: Kiddy-KINDL		3 months	No