Optimizing Health Among Children With Congenital Heart Defects

Status Completed

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00974688
Study type	Interventional
Source	The Hospital for Sick Children
Contact
Status	Completed
Phase	N/A
Start date	July 2009
Completion date	June 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01671566` - Interval Training in Adults With Congenital Heart Disease a Randomized Trial	N/A
Recruiting	`NCT01421030` - Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques	Phase 0
Withdrawn	`NCT00981591` - Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients	Phase 1/Phase 2
Completed	`NCT01567579` - An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
Terminated	`NCT00208676` - Using Tissue Doppler/Synchronization to Determine Heart Function in Children With Congenital Heart Disease	N/A
Completed	`NCT01941576` - Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot	N/A
Completed	`NCT01475357` - Intestinal Function in Neonates With Complex Congenital Heart Disease	N/A
Active, not recruiting	`NCT01227096` - Randomized Controlled Trial of the Effects of Electroacupuncture Preconditioning in Children Undergoing Cardiac Surgery	N/A
Completed	`NCT00397514` - Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery	N/A
Completed	`NCT01201486` - Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester	N/A
Completed	`NCT02232399` - Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?	Phase 2
Completed	`NCT05191654` - Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD
Recruiting	`NCT06267859` - Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children	Early Phase 1
Completed	`NCT02320669` - Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass	Phase 3
Completed	`NCT01489475` - Plasma Angiopoietin Levels in Children Following Cardiopulmonary Bypass	N/A
Withdrawn	`NCT00579358` - Molecular Basis of Congenital Heart Defects
Recruiting	`NCT01196182` - Congenital Heart Disease GEnetic NEtwork Study (CHD GENES)
Recruiting	`NCT04382573` - Better Delineation of CDK13 Related Phenotype and Epigenetic Signature.
Recruiting	`NCT03822442` - MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients
Completed	`NCT00450684` - Cardiac Resynchronization Therapy in Congenital Heart Defects	Phase 2/Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.