24 Participants Needed

Parent-Child Yoga for Congenital Heart Disease

Recruiting at 3 trial locations
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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a parent-child yoga program might improve attention skills in children with congenital heart disease (CHD) who have undergone heart surgery. The researchers aim to determine if this yoga intervention can enhance focus, potentially benefiting academic and social life over time. Participants will either join an 8-week yoga program or be placed on a waitlist, with yoga offered later. Children aged 4 to 6 with CHD and attention difficulties who haven't recently participated in a structured yoga program may be suitable, especially if a parent is willing to join the sessions. As an unphased trial, this study provides a unique opportunity to explore innovative methods for enhancing children's attention skills.

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 prior data suggests that this parent-child yoga intervention is safe for children with congenital heart disease?

Research has shown that parent-child yoga is generally safe for children with congenital heart disease (CHD). This type of yoga includes gentle exercises, which are safe when done in moderation. Studies have found that parent-child yoga can help children focus better and reduce ADHD symptoms. No major reports of negative effects have emerged, making it a well-accepted choice for families. However, participants should follow the instructor's guidance to ensure safety during sessions.12345

Why are researchers excited about this trial?

Researchers are excited about parent-child yoga for congenital heart disease (CHD) because it offers a holistic approach that differs from traditional medical treatments. Unlike standard care, which often involves medication and surgery, this yoga intervention focuses on enhancing neurodevelopmental outcomes through physical and emotional bonding between parents and children. By integrating physical activity and mindfulness, yoga could help improve overall quality of life for children with CHD, potentially offering benefits beyond what conventional treatments provide.

What evidence suggests that parent-child yoga is effective for reducing attention deficits in children with congenital heart disease?

Research shows that practicing yoga with a child might improve attention in children with congenital heart disease (CHD). In this trial, participants in the yoga group will engage in an 8-week parent-child yoga intervention alongside standard care. Studies have found that yoga reduces stress and increases mindfulness, aiding focus. While specific data on this yoga type for children with CHD is limited, early results suggest it can enhance attention and reduce ADHD symptoms in children with similar health issues. This method is promising because it combines exercise with mindfulness, which has benefited other attention-related problems.12346

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.
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 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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Yoga groupExperimental Treatment1 Intervention
Group II: Waitlist control groupActive Control1 Intervention

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+

Published Research Related to This Trial

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]
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.
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]
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.
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]

Citations

A Parent–child yoga intervention for reducing attention deficits ...Both interventions have been shown to be effective in reducing distress with added benefits of the mindfulness programme. However, the efficacy ...
Study Details | NCT05997680 | A Parent-child Yoga ...A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study · Study Overview · Contacts and ...
Parent-Child Yoga for Congenital Heart DiseaseThis study will evaluate the effectiveness of a parent-child yoga intervention for improving attention and reducing ADHD symptoms in 24 preschoolers and school- ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37848299
the Yoga for Little Hearts Feasibility Study ProtocolThis is a single-blind, two-centre, two-arm trial during which 24 children with CHD and their parents will be randomly assigned to (1) a parent-child yoga ...
Randomized Controlled Trial of Working Memory ...A Parent–child yoga intervention for reducing attention deficits in children with congenital heart disease: the Yoga for Little Hearts Feasibility Study ...
BMJ Open is committed to open peer review. As ...aiming to evaluate the efficacy of a parent-child yoga intervention targeting attentional skills in children with congenital heart disease. •. A wide range ...
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