Back to resultsExercise Training in Children With Congenital Heart Defect
Primary Purpose
Congenital Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring Exercise capacity, Physical activity, Quality of life
Eligibility Criteria
Inclusion Criteria:
- Children with congenital heart defect s/p repair > 6 months
- Sedentary lifestyle
Exclusion Criteria:
- Unstable hemodynamics
- Impaired mental and cognition
- Systemic disease
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exercise
Arm Description
Dance Dance Revolution (DDR)
Outcomes
Primary Outcome Measures
maximal treadmill exercise test
Secondary Outcome Measures
Full Information
NCT ID
NCT00930800
First Posted
July 1, 2009
Last Updated
July 19, 2009
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00930800
Brief Title
Exercise Training in Children With Congenital Heart Defect
Official Title
The Effect of Exercise Training on Exercise Capacity, Physical Activity, and Health-related Quality of Life in Children After Repair of Congenital Heart Defect
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Exercise capacity, Physical activity, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Other
Arm Description
Dance Dance Revolution (DDR)
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Dance Dance Revolution (DDR)
Intervention Description
Using a video game so-called Dance Dance Revolution (DDR)
Primary Outcome Measure Information:
Title
maximal treadmill exercise test
Time Frame
12 wks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with congenital heart defect s/p repair > 6 months
Sedentary lifestyle
Exclusion Criteria:
Unstable hemodynamics
Impaired mental and cognition
Systemic disease
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Exercise Training in Children With Congenital Heart Defect
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