- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04106154
Impacting Children's Physical and Mental Health Through Kinesiology Support in Clinical Care
Over the past four decades, it has become clear that childhood physical activity carries with it a myriad of beneficial effects. It is closely linked to quality of life and the recognized benefits include, but are not limited to, optimal growth and development, a healthier self-concept, enhanced peer socialization, and decreased anxiety and depression. Long term, an active lifestyle decreases the risk of many important physical and mental morbidities. Thus, the observation that children living with medical conditions and disabilities (MC&D) today, although surviving longer thanks to advances in medical care, are much less active than their peers is a matter of significant concern. Research indicates that the 350,000 Ontario children with MC&D have lower levels of physical activity, higher screen time and more frequent sleep problems.
While the reasons underlying this reality are complex, previous research has identified a substantial subset of children who are motivated to be active but lack the confidence to do so. Fear of pain, concern for MC&D exacerbation and a lack of confidence in individual physical movement capacity contribute to their hesitation. Clinical experience suggests that these children represent 50% to 70% of inactive patients. Research indicates that being motivated to make a change and having the confidence that the desired change can be achieved are the essential precursors upon which successful behaviour change initiatives are built. This randomized, controlled trial will explore whether group sessions with a Registered Kinesiologist lead to a direct bolstering of physical activity confidence, and in turn to increased and sustained physical activity in these children. Such an approach holds the promise of a nonpharmacologic, low cost and accessible means of enhancing health that shall be met with a high level of patient and family support while bringing a significant societal and medical return on investment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children with MC&D will be eligible to participate if they meet all of the following criteria:
- 8 to 17 years of age and actively followed in an out-patient clinic at the Children's Hospital of Eastern Ontario (CHEO);
- physical activity concerns for the child identified by the patient/parent/healthcare professional;
- able to participate in physical activity as specified by the responsible physician;
- a physical disability limiting physical function or concussion symptoms persisting for > 1 month or chronic pain limiting physical function (post physiotherapy treatment) or a cardiac diagnosis;
- Motivation Ruler score for daily physical activity ≥ 4 (max 10 points) and Confidence Ruler for achieving a change in physical activity < 7 (max 10 points).
Exclusion Criteria:
- have a cognitive disability that prevents them from completing the study assessments;
- are unable to complete the assessments or intervention in either English or French;
- have an acute illness/condition that may impact their physical activity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
12 week physical activity group led by Kinesiologist.
The intervention will be used to increase confidence in the participants by providing physical activity education and a variety of activities.
|
No Intervention: Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Readiness Ruler for Physical Activity Behaviour Change Scores
Time Frame: Baseline, 3 months and 6 months
|
Self rating of motivation for physical activity and confidence for making a change in physical activity (both are 1 (low) to 10 (high) scales as per Miller & Rollnick, Motivational Interviewing: Helping People Change, 2012).
Eligible patients will have high motivation (> 4/10) but low confidence (< 7/10).
|
Baseline, 3 months and 6 months
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Change in Daily Physical Activity Behaviour
Time Frame: Baseline, 3 months and 6 months
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Actical accelerometer data for 7 day period
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Baseline, 3 months and 6 months
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Change in Canadian Assessment of Physical Activity Motivation and Confidence Questionnaire Scores
Time Frame: Baseline, 3 months and 6 months
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Valid and reliable assessment of children's motivation and self-confidence for physical activity participation (www.capl-eclp.ca).
Maximum score of 10 points, higher score indicates more motivation and confidence.
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Baseline, 3 months and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Screen Time
Time Frame: Baseline, 3 months, and 6 months
|
7 day screen time journal
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Baseline, 3 months, and 6 months
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Change in Sleep Time
Time Frame: Baseline, 3 months, and 6 months
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7 day journal
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Baseline, 3 months, and 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Patricia Longmuir, PhD, Children's Hopsital of Eastern Ontario, Research Institute
- Principal Investigator: Hana Alazem, MD, Children's Hospital of Eastern Ontario
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Wounds and Injuries
- Congenital Abnormalities
- Brain Damage, Chronic
- Craniocerebral Trauma
- Trauma, Nervous System
- Cardiovascular Abnormalities
- Brain Concussion
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Cerebral Palsy
- Chronic Pain
- Heart Defects, Congenital
- Post-Concussion Syndrome
- Neuromuscular Diseases
Other Study ID Numbers
- 19/115X
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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