Clinical trial NCT04106154: Impacting Children's Physical and Mental Health Through Kinesiology Support in Clinical Care
Official title: Impacting Children's Physical and Mental Health Through Kinesiology Support in Clinical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2019-09-26
Enrollment: 111
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Children living with medical conditions are often unsure about engaging in active play with friends and peers. Some children are worried that physical activity will increase symptoms of their existing illness and increase overall pain. Other children are unable to keep up with peers, or perceive themselves as not good enough to play. This research study will investigate children with medical conditions or disabilities can be supported to become more confident in one' abilities to play actively with their friends. Children who come to our rehabilitation, long term concussion, chronic pain and cardiology clinics will be invited to participate in this project. Children who agree to participate will be assessed three times, in the 1st, 14th and 27th week of the study. During each assessment, children will be asked to complete a short questionnaire about activity preferences and motivation. The child will be given a small activity monitor, about the size of a toonie, which is worn on a belt around the waist. Each child will be asked to wear the monitor for 7 days before returning it to the investigators. After the 1st week of the study, a coin flip will decide the study group for each child. Children in the control group will only do the three assessment visits. Children selected for the exercise group will come to a group physical activity session that will be held once a week for 12 weeks. At each of the 12 sessions, children will be able to try some active games and sports that are suitable for their medical condition or disability. There will be a group of about 8 children, who have similar interests and concerns about physical activity, at each session. The 12 weekly sessions will each be 2.5 hours in length. The study will evaluate how the children's physical activity and confidence to be active change over the 27 weeks, and compare the changes that occur between the children who do or do not attend the 12 weekly physical activity sessions. The results will indicate whether the 12 weekly sessions effectively increase the physical activity confidence of children with medical conditions and disabilities.

Eligibility criteria: Inclusion Criteria:

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

1. 8 to 17 years of age and actively followed in an out-patient clinic at the Children's Hospital of Eastern Ontario (CHEO);
2. physical activity concerns for the child identified by the patient/parent/healthcare professional;
3. able to participate in physical activity as specified by the responsible physician;
4. 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;
5. 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:

1. have a cognitive disability that prevents them from completing the study assessments;
2. are unable to complete the assessments or intervention in either English or French;
3. have an acute illness/condition that may impact their physical activity.

Primary outcomes:
measure: Change in Readiness Ruler for Physical Activity Behaviour Change Scores
timeFrame: Baseline, 3 months and 6 months
measure: Change in Daily Physical Activity Behaviour
timeFrame: Baseline, 3 months and 6 months
measure: Change in Canadian Assessment of Physical Activity Motivation and Confidence Questionnaire Scores
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Change in Screen Time
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Sleep Time
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hopsital of Eastern Ontario, Research Institute
name: Patricia Longmuir, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Eastern Ontario
name: Hana Alazem, MD
role: PRINCIPAL_INVESTIGATOR
References: