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Physical Activity Program for Congenital Heart Defects

N/A
Recruiting
Research Sponsored by Children's Hospital of Eastern Ontario
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving elective treatment via cardiac surgery or catheterization intervention for CHD at the Children's Hospital of Eastern Ontario.
Be younger than 18 years old
Must not have
Emergency treatment for child in critical condition
Genetic conditions or physical disabilities impacting motor development (e.g., Down syndrome)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Summary

This trial will assess whether a 6-month, home-based, parent-led physical activity program helps young children with congenital heart defects (CHD) get the recommended 180 minutes of daily physical activity.

Who is the study for?
This study is for young children aged 3 to 72 months with congenital heart defects who've had elective surgery or catheterization at the Children's Hospital of Eastern Ontario. It's not suitable for those in critical condition, incompatible medical care, no limb movement, or genetic/physical conditions affecting motor skills.Check my eligibility
What is being tested?
The trial tests a home-based physical activity program led by parents over six months to help these children reach the recommended daily activity levels. The goal is to counteract sedentary tendencies and improve motor skills, setting up for a larger future study.See study design
What are the potential side effects?
Since this intervention involves individualized physical activities appropriate for young children with CHD, side effects are minimal but may include typical risks associated with increased physical activity depending on each child’s health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for heart surgery or a catheter procedure at the Children's Hospital of Eastern Ontario.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My child needs immediate medical attention.
Select...
I have a genetic condition or disability affecting my movement.
Select...
I cannot move my arms or legs on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of data collection procedures measured as % of patients with complete pretreatment data
Feasibility of patient randomization measured as # of patients/parents willing to randomize
Feasibility of patient recruitment measured as # surgical patients, # cath patients, # eligible, # approached, # willing to enroll, # withdrawn
Secondary outcome measures
% compliant with intervention and rate of adherence
Retention and follow up rates measured as # participants retained in study; # follow up sessions complete
Other outcome measures
Clarity of inclusion/exclusion criteria measured as # requiring MD consult for eligibility
Resources to conduct the RCT measured as staff time required
healthcare professionals facilitate recruitment measured as # of days for MD approval
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Wait List Control GroupExperimental Treatment1 Intervention
All children enrolled in the study will complete five study visits. After the first visit is complete, children will be randomized to either the intervention or wait-list control study group. Control participants will follow the same schedule of assessments at each visit, but the intervention will be provided between the 12-month and 16-month assessments. All participants will complete all outcome measures (including surveys, questionnaires, and motor skill assessments) at or after each 1-hour assessment visit. Children will be given an omni-directional accelerometer to wear on a waist-worn belt for 7 days after each visit to assess daily physical activity.
Group II: Intervention GroupExperimental Treatment1 Intervention
All children enrolled in the study will complete five study visits. All participants will complete all outcome measures (including surveys, questionnaires, and motor skill assessments) at or after each 1-hour assessment visit. Children will be given an omni-directional accelerometer to wear on a waist-worn belt for 7 days after each visit to assess daily physical activity. The intervention group will complete individualized, parent-led, home and play-based activity plans for 6 months, beginning as soon as the child returns to the inpatient unit. The activities in the plan will be tailored to each phase of treatment (in hospital, discharge to week 7, week 8 to 6 months), follow a standardized format and provide content individualized to each child's age and previous visit assessments.

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor
127 Previous Clinical Trials
55,399 Total Patients Enrolled
Heart and Stroke Foundation of CanadaOTHER
124 Previous Clinical Trials
72,274 Total Patients Enrolled

Media Library

Individualized Home and Play-Based Physical Activity Plans Clinical Trial Eligibility Overview. Trial Name: NCT04619745 — N/A
Congenital Heart Defects Research Study Groups: Wait List Control Group, Intervention Group
Congenital Heart Defects Clinical Trial 2023: Individualized Home and Play-Based Physical Activity Plans Highlights & Side Effects. Trial Name: NCT04619745 — N/A
Individualized Home and Play-Based Physical Activity Plans 2023 Treatment Timeline for Medical Study. Trial Name: NCT04619745 — N/A
~6 spots leftby Dec 2024
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