Physical Activity Program for Congenital Heart Defects

Overseen By Patricia Longmuir

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Eastern Ontario

Disqualifiers: Genetic conditions, Physical disabilities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 6-month, home-based exercise program led by parents can help young children with congenital heart defects (CHD) remain active after surgery or catheterization. The goal is for these children to engage in at least 180 minutes of activity daily, the recommended amount for their age. The study will collect data to prepare for a future, larger trial. Children who have recently undergone elective heart surgery or a catheter procedure for CHD and are between 3 months and 6 years old may be suitable candidates. The trial includes two groups: one begins the individualized home and play-based physical activity plan immediately, while the other starts later, following initial assessments. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance post-surgery activity levels for young children with CHD.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this physical activity program is safe for children with congenital heart defects?

Research has shown that home-based exercise programs can be safe and beneficial for children with congenital heart defects (CHD). These programs can increase strength, build muscle, and reduce the risk of obesity. Importantly, both children and their families manage these programs well.

One study found that these programs can lead to positive outcomes without causing serious issues. Another study noted that while the long-term effects are still being explored, the early results appear promising. This evidence suggests that a parent-led home exercise plan is a safe way to help young children with CHD become more active. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing congenital heart defects through individualized physical activity plans. Unlike the traditional focus on medical or surgical interventions, this trial emphasizes customized, play-based activities that cater to each child's unique needs and phases of recovery. These plans are designed to integrate seamlessly into daily life, encouraging children to stay active and potentially improving their physical health outcomes. By using home-based activities, this approach aims to enhance motor skills and overall fitness in a fun and engaging way, setting it apart from conventional treatments.

What evidence suggests that this physical activity program is effective for children with congenital heart defects?

Research has shown that home-based exercise programs can benefit children with congenital heart defects (CHD). In this trial, participants in the intervention group will follow individualized, parent-led, home and play-based activity plans for 6 months. One study found that such programs can improve children's health by increasing strength and muscle while reducing the risk of obesity and type 2 diabetes. Another study reported positive outcomes from a 6-month personalized home exercise plan, leading to increased daily activity and improved motivation and movement skills. Evidence suggests that these focused, at-home activities can enhance fitness and physical activity levels. These findings indicate that tailored, play-based exercise plans could help young children with CHD lead healthier lives. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for heart surgery or a catheter procedure at the Children's Hospital of Eastern Ontario.

I am between 3 months and 6 years old.

Exclusion Criteria

My child needs immediate medical attention.

Medical care not compatible with study assessments

I have a genetic condition or disability affecting my movement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive surgical or catheterization treatment followed by a 6-month, home-based, parent-led physical activity program

6 months

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 7 weeks, 6 months, 12 months, and 16 months

18 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Individualized Home and Play-Based Physical Activity Plans

Trial Overview 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.

How Is the Trial Designed?

Group I: Wait List Control Group Experimental Treatment 1 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 Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Children's Hospital of Eastern Ontario

Lead Sponsor

Trials

134

Recruited

61,000+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

Published Research Related to This Trial

Children and adolescents with congenital and acquired heart disease (CHD) often do not get enough physical activity, but exercise interventions can significantly improve their health outcomes.

The cardiac exercise therapeutics (CET) model offers a structured approach to promote physical activity through various levels of intervention, including clinical settings and remote technologies, which could enhance access to exercise programs, especially in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ehealth technology in cardiac exercise therapeutics for pediatric patients with congenital and acquired heart conditions: a summary of evidence and future directions. White, DA., Layton, AM., Curran, T., et al.[2023]

Children and adolescents with congenital heart disease (CHD) should not be absolutely restricted from physical activity, as active lifestyles are crucial for their health, similar to the general population.

Physicians should provide clear guidance on recommended physical activities and personalized exercise prescriptions, starting early in childhood, to promote long-term physical activity and monitor adherence and responses to exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Promotion in Pediatric Congenital Heart Disease: Are We Running Late? Caterini, JE., Campisi, ES., Cifra, B.[2021]

In a study of 236 children with congenital heart disease, those with parent-reported restrictions on body contact or competitive sports had higher BMI z-scores, indicating a potential link between activity restrictions and increased weight.

Children with any type of parent-reported activity restriction showed decreased flexibility and movement skills, suggesting that limiting physical activity may negatively impact overall fitness, while moderate-to-vigorous physical activity and strength were not significantly affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Physical Activity Restrictions on Health-Related Fitness in Children with Congenital Heart Disease. Blanchard, J., McCrindle, BW., Longmuir, PE.[2023]

A study involving 129 children and adolescents with congenital heart disease showed that systematic supervised physical training significantly improved their peak oxygen uptake and physical activity levels compared to a control group.

The intervention also led to better psychosocial outcomes, with reduced internalizing behaviors such as withdrawal and somatic complaints, highlighting the holistic benefits of physical training for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical training in children and adolescents with congenital heart disease. Fredriksen, PM., Kahrs, N., Blaasvaer, S., et al.[2019]

Youth with congenital heart disease (CHD) often have reduced exercise capacity and lower quality of life, highlighting the need for effective exercise interventions, particularly home-based programs that can be monitored via telemedicine.

A new 12-week randomized crossover trial is being conducted to evaluate the effectiveness of a home-based high-intensity interval training program using a video game-linked cycle ergometer, which may provide better cardiorespiratory benefits compared to traditional moderate-intensity exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. Spence, C., Khoo, N., Mackie, A., et al.[2023]

Youth with congenital heart disease, especially those with complex defects, face significant health challenges, but engaging in physical activity can improve their quality of life.

Despite the known benefits of exercise, many young patients have low participation levels and self-efficacy, which increases their risk of obesity and cardiovascular issues, highlighting the need for tailored rehabilitation programs and advocacy for safe physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity participation in youth with surgically corrected congenital heart disease: Devising guidelines so Johnny can participate. Moola, F., McCrindle, BW., Longmuir, PE.[2021]

Exercise and physical activity are safe and effective for both healthy children and those with congenital heart disease (CHD), yet exercise training is not routinely implemented for children with CHD despite its health benefits.

Home-based exercise interventions and high-intensity interval training, which have proven successful in adult cardiac rehabilitation, are underutilized in pediatric care, highlighting a need for better integration of exercise programs for children with CHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in paediatric congenital heart disease: fit for purpose? Amir, NH., Dorobantu, DM., Wadey, CA., et al.[2022]

Exercise programs for children and adolescents with congenital heart disease can improve quality of life and increase physical activity levels, suggesting a beneficial impact on their overall well-being.

Despite the positive effects observed, the review indicates that the exercise programs may not have been as effective as anticipated, highlighting the need for future research to better evaluate and optimize these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Exercise Training on Quality of Life and Psychosocial Functioning in Children with Congenital Heart Disease:A Review of Intervention Studies. Dulfer, K., Helbing, WA., Utens, EMWJ.[2020]

Citations

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2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5259847/

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Effects of 6-month customized home-based exercise on ... While the long-term effects of parent training in home-based exercise are unknown, the study results suggest positive outcomes. Trial ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420300720

Impacting child health outcomes in congenital heart disease Intensive, home-based research interventions can increase daily activity and enhance motivation, motor skill and fitness [10,11], evidence used to support ...

5. researchgate.net researchgate.net/publication/312642866_A_home-based_exercise_program_for_children_with_congenital_heart_disease_following_interventional_cardiac_catheterization_Study_protocol_for_a_randomized_controlled_trial

(PDF) A home-based exercise program for children with ... We anticipate that the home-based exercise program may represent a valuable and efficient intervention for children with CHD and their families.

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Promotion of Physical Activity for Children and Adults With ... Counseling of patients with congenital heart defects should emphasize the importance of daily physical activity and decreasing sedentary behavior as appropriate ...