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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106154
Recruitment Status : Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Dr. Pat Longmuir, Children's Hospital of Eastern Ontario Research Institute

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.


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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


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.
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.



Primary Outcome Measures :
  1. 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).

  2. Change in Daily Physical Activity Behaviour [ Time Frame: Baseline, 3 months and 6 months ]
    Actical accelerometer data for 7 day period

  3. 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.


Secondary Outcome Measures :
  1. Change in Screen Time [ Time Frame: Baseline, 3 months, and 6 months ]
    7 day screen time journal

  2. Change in Sleep Time [ Time Frame: Baseline, 3 months, and 6 months ]
    7 day journal



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Patricia Longmuir, PhD 613-738-3908 plongmuir@cheo.on.ca
Contact: Jenna Yaraskavitch, MHK 613-737-7600 ext 4003 jyaraskavitch@cheo.on.ca

Sponsors and Collaborators
Children's Hospital of Eastern Ontario
The Physicians' Services Incorporated Foundation
Investigators
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Principal Investigator: Patricia Longmuir, PhD Children's Hopsital of Eastern Ontario, Research Institute

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Responsible Party: Dr. Pat Longmuir, Senior Scientist, Children's Hospital of Eastern Ontario Research Institute
ClinicalTrials.gov Identifier: NCT04106154    
Other Study ID Numbers: 19/115X
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Pat Longmuir, Children's Hospital of Eastern Ontario Research Institute:
Physical Activity
Activity Motivation
Activity Confidence
Children
Adolescents
Sleep
Screen Time
Additional relevant MeSH terms:
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Cerebral Palsy
Neuromuscular Diseases
Post-Concussion Syndrome
Heart Defects, Congenital
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Brain Concussion
Head Injuries, Closed
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Wounds, Nonpenetrating