Parent-Child Yoga for Congenital Heart Disease

Recruiting at 1 trial location

Overseen By Marie-Noëlle Simard, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Anne Gallagher

Disqualifiers: Severe developmental delay, Severe physical handicap, others

No Placebo Group

Trial Summary

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.

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 4 5}

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 4 5 6 7}

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. ^{1 5 8 9 10}

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Parent-child yoga (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

References

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]