NCT00930800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
Last Updated

July 21, 2009

Status Verified

July 1, 2009

Enrollment Period

6 months

First QC Date

July 1, 2009

Last Update Submit

July 19, 2009

Conditions

Congenital Heart Disease

Keywords

Exercise capacityPhysical activityQuality of life

Outcome Measures

Primary Outcomes (1)

  • maximal treadmill exercise test

    12 wks

Study Arms (1)

Exercise

OTHER

Dance Dance Revolution (DDR)

Other: Exercise

Interventions

ExerciseOTHER

Using a video game so-called Dance Dance Revolution (DDR)

Also known as: Dance Dance Revolution (DDR)
Exercise

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Unstable hemodynamics
  • Impaired mental and cognition
  • Systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Heart Defects, CongenitalMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2009

First Posted

July 2, 2009

Study Start

December 1, 2007

Primary Completion

June 1, 2008

Study Completion

November 1, 2008

Last Updated

July 21, 2009

Record last verified: 2009-07

Locations

TW(1)