Optimizing Health Among Children With Congenital Heart Defects

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT00974688

Collaborator

(none)

172

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Defects	Behavioral: Information Intervention Behavioral: Demonstration Intervention	N/A

Detailed Description

Therefore, we hypothesize that psychosocial factors are important determinants of PAP in this population. Our most recent research with children who have univentricular heart indicates that gross motor skill and psychosocial factors are significant correlates of PAP. Important psychosocial factors include self-efficacy for activity, uncertainty about activity, and inaccurate perceptions of the child's PAP level, options, and abilities. This study seeks to determine whether gross motor skill and psychosocial factors influence PAP among children with a broad spectrum of cardiac defects. It will also determine the optimal changes to clinical care needed to encourage children with heart defects to develop health-related active lifestyles.

We propose a prospective, randomized, cross-over preliminary clinical trial utilizing both quantitative and qualitative assessments. Through the cross-over design, each subject will complete both interventions (information, demonstration), with the order of intervention delivery randomly determined. Quantitative assessments will document moderate-to-vigorous physical activity (MVPA), gross motor skill, and health-related fitness. Qualitative assessments will evaluate parent/child anxiety about PAP and psychosocial factors influencing PAP. All factors will be assessed at each data collection point.

Study Design

Study Type:

Interventional

Actual Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

Optimizing Health Among Children With Congenital Heart Defects Through Rehabilitation Focused on Physical Activity Determinants

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1	Behavioral: Information Intervention 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. Behavioral: Demonstration Intervention 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.
Active Comparator: Group 2	Behavioral: Information Intervention 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. Behavioral: Demonstration Intervention 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.

Arm

Intervention/Treatment

Active Comparator: Group 1

Behavioral: Information Intervention

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.

Behavioral: Demonstration Intervention

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.

Active Comparator: Group 2

Behavioral: Information Intervention

Behavioral: Demonstration Intervention

Outcome Measures

Primary Outcome Measures

Difference in change of measured moderate-to-vigorous physical activity (MVPA) between groups [Baseline, 4, 8 and 12 month timepoints]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
4 to 11 years of age and attending elementary school at first study visit.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hospital for Sick Children	Toronto	Ontario	Canada

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator: Brain W McCrindle, MD, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brian McCrindle, Staff Cardiologist, The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT00974688

Other Study ID Numbers:

1000012482

First Posted:

Sep 10, 2009

Last Update Posted:

Aug 27, 2013

Last Verified:

Aug 1, 2013

Keywords provided by Brian McCrindle, Staff Cardiologist, The Hospital for Sick Children

Congenital

physical activity participation

Moderate-to-vigorous physical activity

Additional relevant MeSH terms:

Heart Defects, Congenital

Study Results

No Results Posted as of Aug 27, 2013