Parent-Child Yoga for Congenital Heart Disease

Recruiting at 1 trial location

Overseen By Marie-Noëlle Simard, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Anne Gallagher

Disqualifiers: Severe developmental delay, Severe physical handicap, others

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

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if parent-child yoga sessions can help improve attention in young children with congenital heart disease. The study involves children aged 4 to 6 and their parents. Yoga is believed to help these children focus better and reduce symptoms of ADHD. Yoga has been explored as a beneficial intervention for various health conditions, including heart disorders and pain management in children with sickle cell disease.

Will I have to stop taking my current medications?

If your child is taking ADHD medication, they will need to temporarily stop it at least 48 hours before each assessment. For other medications, the protocol does not specify any requirements.

Is parent-child yoga safe for children with congenital heart disease?

Parent-child yoga, as a form of physical activity, is generally considered safe for children with congenital heart disease when the activity is moderate and tailored to the child's condition. Encouraging physical activities, including yoga, can improve quality of life and should be supported, although the specific safety of parent-child yoga interventions has not been extensively studied. ^{1 2 3 4 5}

How does the parent-child yoga treatment for congenital heart disease differ from other treatments?

The parent-child yoga treatment is unique because it focuses on improving attention and reducing ADHD symptoms in children with congenital heart disease through a non-drug, interactive approach involving both parents and children. Unlike traditional medical treatments, this intervention emphasizes mental and emotional well-being alongside physical health. ^{2 3 6 7 8}

What data supports the effectiveness of the treatment Parent-child yoga for children with congenital heart disease?

There is emerging evidence that parent-child yoga can improve attention and reduce ADHD symptoms in children, which may be beneficial for those with congenital heart disease who are at higher risk for attention issues. Additionally, exercise programs, similar to yoga, have shown positive effects on quality of life and psychosocial functioning in children with congenital heart disease. ^{1 2 3 9 10}

Are You a Good Fit for This Trial?

This trial is for children aged 4 to 6 with congenital heart disease who have had heart surgery and show poor attention skills. They must not be on ADHD medication or have severe developmental delays, physical handicaps that prevent yoga, or recent structured yoga experience.

Inclusion Criteria

I am between 4 and 6 years old.

My child struggles with attention and scored low on a specific attention test.

I have been diagnosed with coronary heart disease needing surgery.

Exclusion Criteria

I have a health condition that prevents me from doing yoga.

Confirmed diagnosis of severe developmental or intellectual delay that would prevent successful completion of the planned study testing

My child needs special adaptations to participate in yoga due to a severe physical handicap.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 months

1 visit (in-person)

Recruitment

Recruitment of parent-child dyads for the study

18 months

Treatment

Participants receive an 8-week parent-child yoga intervention

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for adherence and outcomes post-intervention

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Parent-child yoga

Trial Overview The study tests if parent-child yoga can help improve attention in kids with heart defects. It's a small test run to see how well a bigger study might work, looking at things like how many families join and stick with it.

How Is the Trial Designed?

Group I: Yoga group Experimental Treatment 1 Intervention

Participants with CHD undergoing neurodevelopmental assessments and benefiting from the 8-week yoga intervention in addition to standard of care.

Group II: Waitlist control group Active Control 1 Intervention

Participants with CHD undergoing neurodevelopmental assessments at the same time as the yoga group participants and benefiting from standard of care only during the 8 weeks of the intervention. The yoga intervention will be made available to all waitlist control group participants once their trial wave is completed.

Who Is Running the Clinical Trial?

Anne Gallagher

Lead Sponsor

Trials

1

Recruited

20+

Centre Universitaire de Santé McGill

Collaborator

Trials

2

Recruited

120+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

Published Research Related to This Trial

This study will evaluate the effectiveness of a parent-child yoga intervention for improving attention and reducing ADHD symptoms in 24 preschoolers and school-aged children with congenital heart disease (CHD), compared to standard clinical care alone.

The trial will assess various feasibility metrics, including recruitment and retention rates, adherence to the yoga program, and the acceptability of the randomization process, which will inform the design of future larger randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Parent-child yoga intervention for reducing attention deficits in children with congenital heart disease: the Yoga for Little Hearts Feasibility Study Protocol. Simard, MN., Lepage, C., Gaudet, I., et al.[2023]

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]

A study involving 31 children with congenital heart disease showed that attending a 3-day sports camp led to significant improvements in their self-perceived health, including physical functioning and mental health.

After the camp, the children's self-esteem and general behavior were reported to be better than those of healthy peers, suggesting that sports camps can provide valuable benefits for children with cardiac anomalies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in perceived health of children with congenital heart disease after attending a special sports camp. Moons, P., Barrea, C., De Wolf, D., et al.[2019]

Only 4% of children and adolescents who had surgery for congenital heart disease met the recommended levels for moderate physical activity, indicating a significant gap in physical fitness post-surgery.

More than half of the patients and parents expressed a desire for more information and individualized rehabilitation programs to support physical activity, highlighting the need for structured rehabilitation after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of physical activity levels in children and adolescents after surgery for congenital heart disease: preferences and use of physical therapy. van Egmond-van Dam, JC., Vliet Vlieland, TPM., Kuipers, IM., et al.[2022]

A comprehensive 'Cardiac Fitness Program' was developed at Boston Children's Hospital to promote exercise and self-confidence in children and adolescents with congenital heart disease, focusing on optimal fitness rather than rehabilitation.

The program includes a progressive exercise curriculum, a self-learning workbook, a motivational app, and instructional videos, aiming to encourage consistent participation and behavior change in physical activity among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a Comprehensive Pediatric Cardiac Fitness and Rehabilitation Program for Congenital Heart Disease. Gauthier, N., Curran, T., O'Neill, JA., et al.[2020]

Encouraging physical activity in children with congenital heart diseases is crucial for improving their quality of life and life expectancy, despite the temporary increase in risk of cardiac complications during intense activities.

Assessing the risks of physical activity should consider the severity of the heart condition and the type of activity, with stress tests being vital for evaluating physical capacity and ensuring safe participation in moderate or leisure sports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sports in children with congenital heart diseases]. Bosser, G., Moulin-Zinsch, A., Fischer-Atalla, R.[2017]

Exercise training is safe for children and adolescents with congenital heart disease, with no reported adverse events linked to the interventions across 6 trials involving 642 participants.

The training showed efficacy in improving physical fitness, with significant enhancements in exercise capacity and cardiorespiratory fitness in several studies, although the evidence quality is considered low to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of exercise training in children and adolescents with congenital heart disease: A systematic review and descriptive analysis. Anderson, CAJ., Suna, JM., Keating, SE., et al.[2023]

Children with congenital heart disease are generally advised to participate in dynamic sports rather than static ones, as the type of sport can influence their safety and health outcomes.

Recommendations for sports participation should be individualized based on specific medical assessments, including exercise electrocardiograms and echocardiograms, rather than relying on invasive techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Points of departure in sports counseling of children with congenital heart defects]. Rohmer, J., de Knecht, S.[2008]

Children with congenital heart disease should engage in daily physical activity, as it is crucial for their development and can be beneficial for their health.

After a thorough cardiological assessment to identify any risks, a sports medical examination is recommended to tailor advice on appropriate activity levels, helping these children improve both physically and psychologically through participation in sports with peers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Congenital Heart Diseases and Sports]. Wippermann, F., Oberhoffer, R., Hager, A.[2017]

Children with congenital heart disease experience significant neurological and psychosocial challenges that affect their participation in everyday activities, highlighting the need for a holistic approach to their rehabilitation.

Occupational therapy should be integrated into cardiac rehabilitation programs for these children to address not only their physical health but also their behavioral and psychological needs, ensuring they can engage in self-care, productivity, and leisure activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational performance challenges for children with congenital heart disease: a literature review. Imms, C.[2017]

Citations

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

A Parent-child yoga intervention for reducing attention deficits in children with congenital heart disease: the Yoga for Little Hearts Feasibility Study Protocol. [2023]

2. 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]

3. United States pubmed.ncbi.nlm.nih.gov

Changes in perceived health of children with congenital heart disease after attending a special sports camp. [2019]

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

Improvement of physical activity levels in children and adolescents after surgery for congenital heart disease: preferences and use of physical therapy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Establishing a Comprehensive Pediatric Cardiac Fitness and Rehabilitation Program for Congenital Heart Disease. [2020]

6. France pubmed.ncbi.nlm.nih.gov

[Sports in children with congenital heart diseases]. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of exercise training in children and adolescents with congenital heart disease: A systematic review and descriptive analysis. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[Points of departure in sports counseling of children with congenital heart defects]. [2008]

9. Germany pubmed.ncbi.nlm.nih.gov

[Congenital Heart Diseases and Sports]. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Occupational performance challenges for children with congenital heart disease: a literature review. [2017]