Exercise Training in Children With Congenital Heart Defect

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930800
• Other study ID #: 200712010R
• Status: Completed
• Phase: N/A
• First received: July 1, 2009
• Last updated: July 19, 2009
• Start date: December 2007
• Est. completion date: November 2008

Study information

• Verified date: July 2009
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 16 Years

Eligibility

Inclusion Criteria:

• Children with congenital heart defect s/p repair > 6 months

• Sedentary lifestyle

Exclusion Criteria:

• Unstable hemodynamics

• Impaired mental and cognition

• Systemic disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital

Intervention

Other:
• Exercise
Using a video game so-called Dance Dance Revolution (DDR)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal treadmill exercise test		12 wks	No