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

August 26, 2008 updated by: Deutsches Herzzentrum Muenchen
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, D-80636
        • Recruiting
        • Deutsches Herzzentrum Muenchen
        • Sub-Investigator:
          • Milka Pringsheim, MD
      • Munich, Germany, D-80809
        • Recruiting
        • Kuratorium für Prävention und Rehabilitation der TU München
        • Contact:
        • Sub-Investigator:
          • Christoph Lammel, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Experimental: 1
physical training
Behavioral: Motorpedagogic exercise
physical training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Activity: triaxial accelerometry
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
coordinative test: MOT 4-6
Time Frame: 3 months
3 months
coordinative test: LOS KF 18
Time Frame: 3 months
3 months
Quality of life: Kiddy-KINDL
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

February 15, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (Estimate)

February 16, 2007

Study Record Updates

Last Update Posted (Estimate)

August 27, 2008

Last Update Submitted That Met QC Criteria

August 26, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. H00107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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