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

43 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Physical Activity Program for Congenital Heart Defects is an effective treatment?

The available research shows that physical activity programs for children and adolescents with congenital heart defects can improve their physical fitness and quality of life. One study found that children who participated in supervised physical training showed better oxygen uptake and increased physical activity levels compared to those who did not. Another study highlighted that exercise programs can enhance quality of life and reduce feelings of withdrawal and physical complaints. Additionally, home-based interventions using telemedicine can provide convenient access to exercise programs, especially for those living far from specialized centers. These findings suggest that physical activity programs are beneficial for improving both physical and psychosocial outcomes in youth with congenital heart defects. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Individualized Home and Play-Based Physical Activity Plans for congenital heart defects?

Research shows that physical activity and exercise interventions can improve both physical and mental health outcomes in children with congenital heart disease. Home-based and supervised exercise programs have been found to enhance physical activity levels and quality of life, suggesting that similar individualized and play-based plans could be beneficial. ^{1 2 3 4 5}

What safety data exists for physical activity programs in children with congenital heart defects?

The existing research indicates that there is no evidence supporting the absolute restriction of physical activity in children with congenital heart defects (CHD). In fact, physically active lifestyles are important for these children, similar to the general population. Studies suggest that physical activity and exercise interventions can improve physiological and psychosocial outcomes in youth with CHD. However, there are barriers to implementing these programs widely, such as resource limitations and financial costs. Home-based and telemedicine interventions are promising for improving access and convenience, though they traditionally lack the supervision of safety and adherence found in facility-based programs. Overall, while there is a need for more research, particularly on high-intensity interval training and telemedicine solutions, the current evidence supports the safety and benefits of physical activity for children with CHD, except for those with specific conditions like electrical abnormalities. ^{2 3 4 6 7}

Is it safe for children with congenital heart defects to participate in physical activity programs?

Research shows that physical activity is generally safe and beneficial for children with congenital heart defects, as long as they do not have specific conditions like electrical abnormalities. Encouraging an active lifestyle is important, and there is no evidence supporting the need for absolute restrictions on physical activity for these children. ^{2 3 4 6 7}

Is the treatment Individualized Home and Play-Based Physical Activity Plans promising for children with congenital heart defects?

Yes, the treatment is promising because it helps children with congenital heart defects become more active, which is important for their health. It can improve their physical abilities and quality of life, and using home-based plans makes it easier for families to participate, especially those who live far from specialized care centers. ^{2 3 4 6 8}

How is the treatment 'Individualized Home and Play-Based Physical Activity Plans' unique for congenital heart defects?

This treatment is unique because it focuses on personalized, home-based physical activity plans that are led by parents and incorporate play, making it more accessible and engaging for children with congenital heart defects. Unlike traditional hospital-based programs, it allows for flexibility and convenience, especially for families in remote areas, and emphasizes the importance of maintaining an active lifestyle from an early age. ^{2 3 4 6 8}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of physical training in children and adolescents with congenital heart disease. [2019]

2. Switzerland 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Exploring the Promise of Telemedicine Exercise Interventions in Children and Adolescents With Congenital Heart Disease. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Physical activity participation in youth with surgically corrected congenital heart disease: Devising guidelines so Johnny can participate. [2021]

5. Switzerland 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. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Physical Activity Promotion in Pediatric Congenital Heart Disease: Are We Running Late? [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Physical Activity Restrictions on Health-Related Fitness in Children with Congenital Heart Disease. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Exercise training in paediatric congenital heart disease: fit for purpose? [2022]