Congenital Heart Defect Clinical Trial
Official title:
Preventing Sedentary Lifestyles Among Children Born With Congenital Heart Defects; A Feasibility Study of Physical Activity After Surgical or Catheterization Intervention
This feasibility study will assess whether a 6-month, home-based, parent-led physical activity program, completed after surgical or catheterization treatment, enables young children with congenital heart defects (CHD) to achieve the recommended 180 minutes of daily physical activity. This study includes comprehensive measures of motor skill and physical activity, intervening at a very young age, and targeting the high risk status for sedentary lifestyles of children with CHD. This study will provide essential data on patient recruitment, data collection procedures, the proposed physical activity intervention and resources required to enable the design of a randomized controlled trial (RCT) to evaluate play-based, parent-delivered interventions optimized to support age-appropriate physical activity and motor skills among young children with CHD.
Status | Recruiting |
Enrollment | 56 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 72 Months |
Eligibility | Inclusion Criteria 1. Female or male at least 3 months of age but not more than 72 months of age (upper age limit for valid Peabody Motor Development Scales-2 assessment) 2. Receiving elective treatment via cardiac surgery or catheterization intervention for CHD at the Children's Hospital of Eastern Ontario. Exclusion Criteria 1. Genetic conditions or physical disabilities impacting motor development (e.g., Down syndrome) 2. Emergency treatment for child in critical condition 3. Medical care not compatible with study assessments 4. No independent limb movement. |
Country | Name | City | State |
---|---|---|---|
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Eastern Ontario | Heart and Stroke Foundation of Canada |
Canada,
Abidin RR. Parenting Stress Index. 3rd ed. Odessa, Florida: Psychological Assessment Resources, Inc.; 1990.
Bar-Or O, Rowland TW. Habitual activity and energy expenditure in the healthy child. Pediatric Exercise Medicine: From Physiologic Principles to Health Care Application. Champaign, IL: Human Kinetics; 2004. p. 64-7.
Centers for Disease Control. Physical activity for everyone: The importance of physical activity. 2005; Available at: URL: http://www.cdc.gov/nccdphp/dnpa/physical/importance/index.htm. Accessed August 9, 2007.
Ginsburg KR; American Academy of Pediatrics Committee on Communications; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health. The importance of play in promoting healthy child development and maintaining strong parent-child bonds. Pediatrics. 2007 Jan;119(1):182-91. doi: 10.1542/peds.2006-2697. — View Citation
Klavora P. Foundations of Exercise Science. Toronto, Ontario: Sport Books Publisher; 2004.
Longmuir PE, McCrindle BW. Physical activity restrictions for children after the Fontan operation: disagreement between parent, cardiologist, and medical record reports. Am Heart J. 2009 May;157(5):853-9. doi: 10.1016/j.ahj.2009.02.014. — View Citation
Project DATA. Social Skills Checklist. 2007. St. Louis, University of Washington. 7-20-2019. Ref Type: Serial (Book,Monograph)
Stieber NA, Gilmour S, Morra A, Rainbow J, Robitaille S, Van Arsdell G, McCrindle BW, Gibson BE, Longmuir PE. Feasibility of improving the motor development of toddlers with congenital heart defects using a home-based intervention. Pediatr Cardiol. 2012 Apr;33(4):521-32. doi: 10.1007/s00246-011-0144-0. Epub 2011 Nov 25. — View Citation
Timmons BW, Naylor PJ, Pfeiffer KA. Physical activity for preschool children--how much and how? Can J Public Health. 2007;98 Suppl 2:S122-34. — View Citation
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clarity of inclusion/exclusion criteria measured as # requiring MD consult for eligibility | Monthly: # inclusion/exclusion is clear, # requiring MD consult for eligibility, # ineligible after baseline, # of patients excluded who could participate | 18 months | |
Other | healthcare professionals facilitate recruitment measured as # of days for MD approval | Monthly: # of days prior to treatment schedule is set, time to screen eligibility, # of days for MD approval, # of days for circle of care contact, # of days for family contact/consent | 18 months | |
Other | study time and burden measured as parent rating of time and burden (100mm visual analogue scale) | Per visit: Parent rate a) time and b) burden (100mm visual analogue scale) End of study: Ratings of time and burden by healthcare professionals | 18 months | |
Other | intervention time and burden measured as parent rating of time and burden (100mm visual analogue scale) | Per visit: Parent rate time and burden (1 to 100 scale, higher number meaning more burden) and provide qualitative feedback End of study: Ratings of time and burden and qualitative feedback from healthcare professionals | 18 months | |
Other | Resources to conduct the RCT measured as staff time required | staff time required to identify, consent and follow patients; space available for baseline testing; kinesiologist time to create and support interventions | 18 months | |
Primary | Feasibility of patient recruitment measured as # surgical patients, # cath patients, # eligible, # approached, # willing to enroll, # withdrawn | Monthly: # surgical patients, # cath patients, # eligible, # approached, # willing to enroll, # withdrawn | 18 months | |
Primary | Feasibility of patient randomization measured as # of patients/parents willing to randomize | Monthly: # of patients/parents willing to randomize | 18 months | |
Primary | Feasibility of data collection procedures measured as % of patients with complete pretreatment data | % of patients with complete pretreatment data; days available prior to treatment for baseline data collection; % of parents able to complete child accelerometer wear for 7 days; % of control and intervention who complete all data sessions; frequency of missing data | 18 months | |
Secondary | Retention and follow up rates measured as # participants retained in study; # follow up sessions complete | End of Study: # participants retained in study; # follow up sessions complete | 18 months | |
Secondary | % compliant with intervention and rate of adherence | Per follow up call: % of participants that completed each intervention, % of sessions completed weekly | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04136379 -
Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
|
||
Recruiting |
NCT02258724 -
Swiss National Registry of Grown up Congenital Heart Disease Patients
|
||
Completed |
NCT01212289 -
Use of ROTEM® in Pediatric Cardiac Surgical Patients
|
N/A | |
Completed |
NCT04090827 -
The Transitioning Rural Adolescents to Adult Care Study
|
N/A | |
Completed |
NCT03311438 -
Oral Health Intervention Program for Children With Congenital Heart Defects
|
N/A | |
Active, not recruiting |
NCT04271358 -
Peer Coaching Intervention in Young Adults With Congenital Heart Disease
|
N/A | |
Terminated |
NCT00451698 -
Erythropoietin and Pediatric Cardiac Surgery
|
N/A | |
Recruiting |
NCT04106479 -
NIRS in Congenital Heart Defects - Correlation With Echocardiography
|
||
Recruiting |
NCT04437069 -
Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making
|
N/A | |
Completed |
NCT04106154 -
Impacting Children's Physical and Mental Health Through Kinesiology Support in Clinical Care
|
N/A | |
Recruiting |
NCT03297658 -
Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.
|
N/A | |
Recruiting |
NCT03512613 -
A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects
|
||
Recruiting |
NCT05698277 -
Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
|
||
Completed |
NCT04056416 -
Physical Activity Promotion in Children and Adolescents With Single Ventricle Physiology (MedBike)
|
N/A | |
Active, not recruiting |
NCT03110861 -
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
|
N/A | |
Completed |
NCT02387944 -
Bedside Evaluation of Coagulation in Children With Congenital Heart Disease
|
N/A | |
Completed |
NCT03348397 -
Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns
|
N/A | |
Completed |
NCT02968264 -
Tetralogy of Fallot for Life
|
||
Completed |
NCT03611374 -
Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study
|
N/A | |
Completed |
NCT03143348 -
Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass
|