Congenital Heart DefectNCT04106154
Impacting Children's Physical and Mental Health Through Kinesiology Support in Clinical Care
A study testing Kinesiology Support in people with Congenital Heart Defect and Chronic Pain, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Congenital Heart Defect, Chronic Pain, Concussion Post Syndrome
- What is being tested?
- Kinesiology Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteCanada
- Study dates
- 4 Nov 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Congenital Heart Defect, Chronic Pain, Concussion Post Syndrome, Cerebral Palsy, Neuromuscular Diseases, Physical Disability
- Being tested
- Kinesiology Support
- Keywords
- Physical Activity, Activity Motivation, Activity Confidence, Children, Adolescents, Sleep, Screen Time
- Medical subject headings
- Heart Defects, Congenital, Chronic Pain, Post-Concussion Syndrome, Cerebral Palsy, Neuromuscular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiology SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3 months and 6 months
Change in Daily Physical Activity Behaviour
Actical accelerometer data for 7 day period
Measured: 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.
Measured: Baseline, 3 months and 6 months
Secondary outcomes (2)
Change in Screen Time
7 day screen time journal
Measured: Baseline, 3 months, and 6 months
Change in Sleep Time
7 day journal
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start4 Nov 2019
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Dr. Pat Longmuir, Children's Hospital of Eastern Ontario
- Investigators
- Patricia Longmuir, PhD, Principal investigator, Children's Hopsital of Eastern Ontario, Research InstituteHana Alazem, MD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106154
- Sponsor's protocol ID
- 19/115X
- Status last verified
- Aug 2023
- First submitted
- 24 Sep 2019
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40756554
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacting Children's Physical and Mental Health Through Kinesiology Support in Clinical Care
- ClinicalTrials.gov ID
- NCT04106154
- Acronym / sponsor ID
- 19/115X
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Kinesiology SupportThe 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. |
| 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesiology Support12 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. | Behavioural | Intervention |
Primary outcome
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.
2 secondary outcomes
Change in Screen Time
Time frame: Baseline, 3 months, and 6 months
Change in Sleep Time
Time frame: Baseline, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 40756554Alazem 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Longmuir, PhD principal investigator
Children's Hopsital of Eastern Ontario, Research Institute
Hana Alazem, MD principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiology Support in people with Congenital Heart Defect and Chronic Pain, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Readiness Ruler for Physical Activity Behaviour Change Scores (time frame: Baseline, 3 months and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04106154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.