Impacting Children's Physical and Mental Health Through Kinesiology Support in Clinical Care
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|ClinicalTrials.gov Identifier: NCT04106154|
Recruitment Status : Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Defect Chronic Pain Concussion Post Syndrome Cerebral Palsy Neuromuscular Diseases Physical Disability||Behavioral: Kinesiology Support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||A research assistant or graduate student blind to participants' intervention status will complete all measures.|
|Primary Purpose:||Supportive Care|
|Official Title:||Impacting Children's Physical and Mental Health Through Kinesiology Support in Clinical Care|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||October 31, 2021|
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.
Behavioral: Kinesiology Support
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.
- 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).
- Change in Daily Physical Activity Behaviour [ Time Frame: Baseline, 3 months and 6 months ]Actical accelerometer data for 7 day period
- Change in Canadian Assessment of Physical Activity Motivation and Confidence Questionnaire Scores [ Time Frame: Baseline, 3 months and 6 months ]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.
- Change in Screen Time [ Time Frame: Baseline, 3 months, and 6 months ]7 day screen time journal
- Change in Sleep Time [ Time Frame: Baseline, 3 months, and 6 months ]7 day journal
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106154
|Contact: Patricia Longmuir, PhDfirstname.lastname@example.org|
|Contact: Jenna Yaraskavitch, MHK||613-737-7600 ext email@example.com|
|Principal Investigator:||Patricia Longmuir, PhD||Children's Hopsital of Eastern Ontario, Research Institute|