Trial record 5 of 640 for:    "Heart Defects, Congenital"

Optimizing Health Among Children With Congenital Heart Defects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian McCrindle, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00974688
First received: September 9, 2009
Last updated: August 25, 2013
Last verified: August 2013
  Purpose

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 Intervention
Congenital Heart Defects
Behavioral: Information Intervention
Behavioral: Demonstration Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Optimizing Health Among Children With Congenital Heart Defects Through Rehabilitation Focused on Physical Activity Determinants

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Difference in change of measured moderate-to-vigorous physical activity (MVPA) between groups [ Time Frame: Baseline, 4, 8 and 12 month timepoints ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gross motor skill [ Time Frame: Baseline, 4, 8 and 12 month timepoints ] [ Designated as safety issue: No ]
  • Psychosocial variables [ Time Frame: Baseline, 4, 8 and 12 month timepoints ] [ Designated as safety issue: No ]
  • Health-related fitness [ Time Frame: Baseline, 4, 8 and 12 month timepoints ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: July 2009
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974688

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Brian McCrindle, Staff Cardiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00974688     History of Changes
Other Study ID Numbers: 1000012482
Study First Received: September 9, 2009
Last Updated: August 25, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Congenital
physical activity participation
Moderate-to-vigorous physical activity

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014