NCT00974688

Brief Summary

Quality of life and heart health are intimately connected to childhood physical activity participation (PAP). Physical activity is critical to childhood growth, development, learning, socialization, and quality of life and is an essential component of life-long heart health. Research by the investigators of this study and others has shown that low PAP levels are common among children with heart defects, and that these sedentary lifestyles are not related to exercise capacity, medical status or heart function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 27, 2013

Status Verified

August 1, 2013

Enrollment Period

2.4 years

First QC Date

September 9, 2009

Last Update Submit

August 25, 2013

Conditions

Congenital Heart Defects

Keywords

Congenitalphysical activity participationModerate-to-vigorous physical activity

Outcome Measures

Primary Outcomes (1)

  • Difference in change of measured moderate-to-vigorous physical activity (MVPA) between groups

    Baseline, 4, 8 and 12 month timepoints

Secondary Outcomes (3)

  • Gross motor skill

    Baseline, 4, 8 and 12 month timepoints

  • Psychosocial variables

    Baseline, 4, 8 and 12 month timepoints

  • Health-related fitness

    Baseline, 4, 8 and 12 month timepoints

Study Arms (2)

Group 1

ACTIVE COMPARATOR
Behavioral: Information InterventionBehavioral: Demonstration Intervention

Group 2

ACTIVE COMPARATOR
Behavioral: Information InterventionBehavioral: Demonstration Intervention

Interventions

Information InterventionBEHAVIORAL

The information intervention is designed to ensure that the parent(s) and child have a clear understanding of the range of physical activity opportunities that are appropriate and recommended for the child. The information intervention will be comprised of discussions and written information.

Group 1Group 2
Demonstration InterventionBEHAVIORAL

The demonstration intervention will be designed to demonstrate to the child and parent(s) specifically what the child is able to do in relation to fitness and motor skill activities. The demonstration intervention will consist of having the child complete a standardized exercise testing protocol on the treadmill, followed by discussions with the child and parent(s) to convey the results of the study testing of fitness and gross motor skill.

Group 1Group 2

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Successful repair of one of the following congenital heart defects: transcatheter device closure of atrial septal defect (ASD), arterial switch repair of transposition of the great arteries (TGA), surgical repair of tetralogy of Fallot (TOF), or Fontan procedure for a functionally univentricular heart (UVH).
  • At least one year after most recent open heart surgery.
  • to 11 years of age and attending elementary school at first study visit.

You may not qualify if:

  • Identification of exercise contraindications/limitations by the responsible cardiologist.
  • Other disabilities or medical conditions that may influence PAP. Children who achieve 90 minutes of MVPA on 5 or more days per week during the baseline assessment will be excluded from the intervention phase. The study interventions are not designed to increase MVPA among children who already achieve the Health Canada guidelines for PAP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

  • Brain W McCrindle, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Cardiologist

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

August 27, 2013

Record last verified: 2013-08

Locations

CA(1)