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

Primary Purpose

Heart Defects, Congenital

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Motorpedagogic exercise
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Defects, Congenital focused on measuring congenital heart disease, exercise training, motorpedagogical exercise, children, CHD: hemodynamically not significant defects, CHD: acyanotic defects after repair, CHD: cyanotic defects after repair

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deutsches Herzzentrum MuenchenRecruiting
  • Kuratorium für Prävention und Rehabilitation der TU MünchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

physical training

Outcomes

Primary Outcome Measures

Activity: triaxial accelerometry

Secondary Outcome Measures

coordinative test: MOT 4-6
coordinative test: LOS KF 18
Quality of life: Kiddy-KINDL

Full Information

First Posted
February 15, 2007
Last Updated
August 26, 2008
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Lehrstuhl für Präventive und Rehabilitative Sportmedizin der TU Muenchen, Kuratorium für Prävention und Rehabilitation an der TU Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT00436098
Brief Title
Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)
Official Title
Pediatric Exercise With Congenital Heart Defects (Kinderturnen Mit Angeborenem Herzfehler)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
Lehrstuhl für Präventive und Rehabilitative Sportmedizin der TU Muenchen, Kuratorium für Prävention und Rehabilitation an der TU Muenchen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital
Keywords
congenital heart disease, exercise training, motorpedagogical exercise, children, CHD: hemodynamically not significant defects, CHD: acyanotic defects after repair, CHD: cyanotic defects after repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
physical training
Arm Title
2
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Motorpedagogic exercise
Intervention Description
physical training
Primary Outcome Measure Information:
Title
Activity: triaxial accelerometry
Time Frame
3 months
Secondary Outcome Measure Information:
Title
coordinative test: MOT 4-6
Time Frame
3 months
Title
coordinative test: LOS KF 18
Time Frame
3 months
Title
Quality of life: Kiddy-KINDL
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alfred Hager, MD
Phone
+49-89-1218
Ext
1650
Email
a-hager@web.de
First Name & Middle Initial & Last Name or Official Title & Degree
Milka Pringsheim, MD
Phone
+49-89-1218
Ext
1301
Email
pringsheim@dhm.mhn.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred Hager, MD
Organizational Affiliation
Deutsches Herzzentrum München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
D-80636
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milka Pringsheim, MD
Facility Name
Kuratorium für Prävention und Rehabilitation der TU München
City
Munich
ZIP/Postal Code
D-80809
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Lammel, PhD
Phone
+49-89-289
Ext
24420
Email
kuratorium.pr@sport.med.tum.de
First Name & Middle Initial & Last Name & Degree
Christoph Lammel, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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