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Kinesiology Support for Congenital Heart Defects

N/A

Waitlist Available

Led By Hana Alazem, MD

Research Sponsored by Children's Hospital of Eastern Ontario

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months and 6 months

Awards & highlights

Study Summary

This trial will explore whether group sessions with a Registered Kinesiologist lead to increased and sustained physical activity in children with medical conditions and disabilities, by bolstering physical activity confidence.

Eligible Conditions

Congenital Heart Defects
Cerebral Palsy
Post-Concussion Syndrome
Physical Disabilities
Chronic Pain
Neuromuscular Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Canadian Assessment of Physical Activity Motivation and Confidence Questionnaire Scores

Change in Daily Physical Activity Behaviour

Change in Readiness Ruler for Physical Activity Behaviour Change Scores

Secondary outcome measures

Change in Screen Time

Change in Sleep Time

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

The kinesiology intervention will involve physical activity education appropriate to the MC&D delivered in a group format through twelve 2.5-hour weekly sessions49 (30 hours of kinesiology support). The sessions will combine participation in physical activities appropriate to the MC&D with education and goal-setting discussions. Each week, children will be guided to develop an individualized SMART (Specific, Measurable, Agreed upon, Realistic, Time-based) plan for changing their activity behaviour. Their weekly SMART plan, which will require an additional 2 hours per week, will specify the home/community activities they will do prior to the next session.

Group II: ControlActive Control1 Intervention

Patients in the control group will continue with clinical care as usual. To encourage their cooperation, children in the control group will be offered the intervention after all of their study visits have been completed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Kinesiology Support

2019

N/A

~120

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Who is running the clinical trial?

The Physicians' Services Incorporated FoundationOTHER

162 Previous Clinical Trials

26,644 Total Patients Enrolled

Children's Hospital of Eastern OntarioLead Sponsor

126 Previous Clinical Trials

55,371 Total Patients Enrolled

Hana Alazem, MDPrincipal InvestigatorChildren's Hospital of Eastern Ontario

Frequently Asked Questions

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

Who is eligible to join this clinical experiment?

"To qualify for this study, applicants must have a diagnosis of chronic pain and be between 8-17 years old. An estimated 128 patients will ultimately be accepted."

Answered by AI

Are there currently any available spots for participants in this research endeavor?

"At the present time, clinicaltrials.gov does not show that this medical trial is enrolling participants; it was first listed on November 4th 2019 and its latest update occurred on August 12th 2022. Nevertheless, there are still 746 other studies actively seeking volunteers as we speak."

Answered by AI