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Parent-Child Yoga for Congenital Heart Disease

N/A

Recruiting

Research Sponsored by Anne Gallagher

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 4 to 6 years old

Poor attentional skills measured with Variability score (0.5 standard deviation below norms) at the Kiddie Conners Continuous Performance Test, 2nd Edition (K-CPT2), a sensitive measure for attentional impairments. This inclusion criteria is important since yoga intervention has shown larger effects on attention in children with greater difficulties before the intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months prior to the intervention.

Awards & highlights

Study Summary

This trial will assess if a parent-child yoga program can reduce attention deficits in children with Congenital Heart Disease, to ultimately improve their long-term academic & psychosocial functioning & quality of life.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves parent-child yoga, side effects are minimal but may include typical exercise-related issues such as muscle soreness. There should be no severe side effects unless there's an underlying condition that makes yoga unsafe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 4 and 6 years old.

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

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I have been diagnosed with coronary heart disease needing surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months prior to the intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months prior to the intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and months prior to the intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of the randomisation process

Adherence

Dropout and withdrawal rates

+4 more

Trial Design

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre Universitaire de Santé McGillUNKNOWN

1 Previous Clinical Trials

98 Total Patients Enrolled

Anne GallagherLead Sponsor

Heart and Stroke Foundation of CanadaOTHER

123 Previous Clinical Trials

72,160 Total Patients Enrolled

Media Library

Yoga group Clinical Trial Eligibility Overview. Trial Name: NCT05997680 — N/A

Neurodevelopmental Disorders Research Study Groups: Yoga group, Waitlist control group

Neurodevelopmental Disorders Clinical Trial 2023: Yoga group Highlights & Side Effects. Trial Name: NCT05997680 — N/A

Yoga group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05997680 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals over 35 years of age partake in this trial?

"According to the trial's entrance criteria, children aged between 4 and 6 can participate in this clinical study."

Answered by AI

Who is eligible to participate in this medical research?

"The requirements for this trial are pediatric patients between the ages of 4 and 6 that have been diagnosed with a neurodevelopmental disorder. Up to 24 candidates will be accepted into the study."

Answered by AI

Are there opportunities for new participants to join the trial?

"The study, listed on clinicaltrials.gov and initially posted on October 1st 2023, is still actively recruiting participants. It was last amended on August 11th 2023."

Answered by AI

How many participants is this research endeavor accommodating?

"Affirmatively, according to clinicaltrials.gov this therapeutic experiment is recruiting participants. It was first initiated on October 1st 2023 and recently modified on August 11th 2023. A total of 24 subjects are needed from 2 disparate medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Parent-child Yoga Intervention for Reducing Attention Deficits in Children With Congenital Heart Disease: A Feasibility Study

Anne Gallagher 2023. "A Parent-child Yoga Intervention for Reducing Attention Deficits in Children With Congenital Heart Disease: A Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05997680.

All > Heart Disease