24 Participants Needed

Parent-Child Yoga for Congenital Heart Disease

Recruiting at 1 trial location
AG
MS
Overseen ByMarie-Noëlle Simard, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Anne Gallagher
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

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.14567

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.158910

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.

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.
See 2 more

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.
See 2 more

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
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
2Treatment groups
Experimental Treatment
Active Control
Group I: Yoga groupExperimental Treatment1 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 groupActive Control1 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.

Find a Clinic Near You

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

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.
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.
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.
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]

References

A Parent-child yoga intervention for reducing attention deficits in children with congenital heart disease: the Yoga for Little Hearts Feasibility Study Protocol. [2023]
The Influence of Exercise Training on Quality of Life and Psychosocial Functioning in Children with Congenital Heart Disease:A Review of Intervention Studies. [2020]
Changes in perceived health of children with congenital heart disease after attending a special sports camp. [2019]
Improvement of physical activity levels in children and adolescents after surgery for congenital heart disease: preferences and use of physical therapy. [2022]
Establishing a Comprehensive Pediatric Cardiac Fitness and Rehabilitation Program for Congenital Heart Disease. [2020]
[Sports in children with congenital heart diseases]. [2017]
Safety and efficacy of exercise training in children and adolescents with congenital heart disease: A systematic review and descriptive analysis. [2023]
[Points of departure in sports counseling of children with congenital heart defects]. [2008]
[Congenital Heart Diseases and Sports]. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Occupational performance challenges for children with congenital heart disease: a literature review. [2017]
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