Impacting Children's Physical and Mental Health Through Kinesiology Support in Clinical Care

NCT04106154 | Completed

• 1 other identifier: 19/115X
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Defect; Chronic Pain; Concussion Post Syndrome; Cerebral Palsy; Neuromuscular Diseases; Physical Disability

Keywords

Physical Activity; Activity Motivation; Activity Confidence; Children; Adolescents; Sleep; Screen Time

Outcome Measures

Primary Outcomes (3)

• Change in Readiness Ruler for Physical Activity Behaviour Change Scores

  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

• Change in Daily Physical Activity Behaviour

  Actical accelerometer data for 7 day period

  Baseline, 3 months and 6 months

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

  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.

  Baseline, 3 months and 6 months

Secondary Outcomes (2)

• Change in Screen Time

  Baseline, 3 months, and 6 months

• Change in Sleep Time

  Baseline, 3 months, and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO 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.

Interventions

Kinesiology Support BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with MC\&D will be eligible to participate if they meet all of the following criteria:
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (1)

• Alazem H, Yaraskavitch J, Blais A, McCormick AM, Lougheed J, Lamontagne C, Goulet KB, Tsampalieros A, Ward LM, Katz SL, Robinson ME, Abbott LS, Kovesi TA, Reisman JJ, Pohl D, Webster RJ, Longmuir PE. Impacting the physical activity confidence of children with medical conditions or disabilities: A randomized controlled trial. Paediatr Child Health. 2025 Mar 27;30(4):257-267. doi: 10.1093/pch/pxae085. eCollection 2025 Jul.

  PMID: 40756554 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Chronic Pain; Post-Concussion Syndrome; Cerebral Palsy; Neuromuscular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Behavior

Study Officials

• Patricia Longmuir, PhD

  Children's Hopsital of Eastern Ontario, Research Institute

  PRINCIPAL INVESTIGATOR

• Hana Alazem, MD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research assistant or graduate student blind to participants' intervention status will complete all measures.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: November 4, 2019
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)