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A Feasibility Study of Physical Activity After Surgical or Catheterization Intervention

NCT04619745 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-03-17

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Heart Defect

Interventions

OTHER

Individualized Home and Play-Based Physical Activity Plans

Play-based, parent led interventions optimized to support age appropriate physical activity, and motor skills among young children with congenital heart defects.

Sponsors & Collaborators

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • Children's Hospital of Eastern Ontario

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
72 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04619745 on ClinicalTrials.gov