Exercise Training in Children With Congenital Heart Defect

This study has been completed.

Sponsor:

Information provided by:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT00930800

First received: July 1, 2009

Last updated: July 19, 2009

Last verified: July 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	July 1, 2009
Last Updated Date	July 19, 2009
Start Date ^ICMJE	December 2007
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 1, 2009)	maximal treadmill exercise test [ Time Frame: 12 wks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00930800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Exercise Training in Children With Congenital Heart Defect
Official Title ^ICMJE	The Effect of Exercise Training on Exercise Capacity, Physical Activity, and Health-related Quality of Life in Children After Repair of Congenital Heart Defect
Brief Summary	The purpose of this study was to investigate the effects of exercise training on exercise capacity, physical activity (PA), health-related quality of life (HRQoL), and the psychosocial factors affecting PA in sedentary congenital heart defect (CHD) children and healthy sedentary children. The degree of improvement after exercise training were compared between CHD children and healthy sedentary children.
Detailed Description	Exercise groups took 12-week exercise training, twice in hospital and once at home, using a video game so-called Dance Dance Revolution (DDR), while the control group kept their daily routines.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Congenital Heart Disease
Intervention ^ICMJE	Other: Exercise Using a video game so-called Dance Dance Revolution (DDR) Other Name: Dance Dance Revolution (DDR)
Study Arm (s)	Exercise Dance Dance Revolution (DDR) Intervention: Other: Exercise
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	November 2008
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Children with congenital heart defect s/p repair > 6 months Sedentary lifestyle Exclusion Criteria: Unstable hemodynamics Impaired mental and cognition Systemic disease
Gender	Both
Ages	7 Years to 16 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Taiwan

Administrative Information
NCT Number ^ICMJE	NCT00930800
Other Study ID Numbers ^ICMJE	200712010R
Has Data Monitoring Committee	Yes
Responsible Party	Ying-Tai Wu, National Taiwan University
Study Sponsor ^ICMJE	National Taiwan University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Taiwan University Hospital
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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