Enhanced Physical Activity Support in Congenital Heart Disease Clinical Care

NCT ID: NCT03435354

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-05
• Study Completion Date: 2023-05-31

Brief Summary

Our cluster randomized controlled trial of a novel clinical practice change will IMPACT the physical activity (PA) of children living with congenital heart defects (CHD) through our

Innovative and pragmatic approach to systematically incorporate PA counselling within each clinic visit. Long-term, the focus is to prevent or treat the most common secondary morbidities of these patients (atherosclerosis, anxiety, depression) through enhanced PA. We have previously shown that home-based, PA interventions can increase daily PA and enhance PA motivation, motor skill and fitness when delivered via an intensive research intervention. Our objectives for this study are to

Measure the feasibility and efficacy of PA counselling using clinical resources among paediatric CHD patients (daily PA, PA motivation, competence, quality of life) and on clinic systems (% patients counselled, clinic/kinesiology personnel support required, clinic visit time, # of PA questions). Our

Patient-empowering, ready-to-use, self-explanatory "tool kit" of clinician PA resources and patient/family/clinician friendly searchable electronic PA database will be used to promote the

Active lifestyles that are critically important to physical/mental health, peer socialization & childhood growth/development. 90% of children are not active enough for optimal health.

We initially target children with CHD because they are less active than peers, and their most important secondary morbidities can be prevented or treated through PA. Our

Collaborative approach with patients, their families and leaders in paediatric cardiac healthcare will optimize our "PA tool kit" and novel practice change for

Translation to all paediatric CHD healthcare systems (primary, secondary, tertiary) through our pan-Canadian Cardiac Kids Quality of LIFFE Research and Knowledge Exchange Network, a collaborative of 10 patient/family support networks and 10 paediatric cardiac clinics in 6 provinces focused on Learning, Independence, Friends, Fitness & Emotional health (LIFFE).

Detailed Description

Inactive lifestyles have a huge cost to Canadians' health, our economy and healthcare system (3.7% of total healthcare costs, 2009=$6.8B19). If 10% of Canadians were more active, 25-yr healthcare costs would drop by $2.6B, $7.5B would be added to our economy, & 550,000 fewer Canadians would live with chronic disease. Congenital heart disease (CHD) is the most common congenital condition (12/1000 births) and a major health burden. 90% of CHD children live 4 to 8 decades with a 3-5X higher risk for atherosclerosis, anxiety or depression. Physical activity is known to decrease these important health risks. <10% of Canadian children are active enough for optimal health and, regardless of severity, CHD children are even less active. Individualized kinesiology support can improve physical activity (PA) skill, confidence and participation among CHD children but exceeds current clinical care resources. In response, our team of patients, parents, and clinicians developed a "tool kit" of 12 child/family-friendly PA resources to enable clinicians to better address the most important PA issues for these patients. Our randomized, controlled trial will evaluate a clinical practice change (systematic PA counselling with the PA tool kit plus PA in CHD database) on patient PA and health system outcomes in small (London), medium (Ottawa) and large (Edmonton) paediatric cardiac clinics. Randomization will be by week within each study site to prevent potential intervention cross contamination between children in clinic at the same time. Primary outcome is daily pedometer steps over 1 week. Secondary outcomes are quality of life (PedsQL), physical literacy (CAPL screen) and PA motivation (CSAPPA). Health system outcomes will be: % patients receiving intervention, clinic visit time, # of non-clinic contacts about PA, and need for kinesiology referral. Patient outcomes will be assessed during the CHD clinic visit and at 6 months, with pedometer steps also measured each month. We will enroll consecutive CHD patients with moderate or severe CHD, 5 - 17 yrs, & no other diagnosis affecting PA. Based on our data from previous PA studies among CHD patients and anticipating 10 patients/month, we would require 15 months of data collection (10% dropout) to obtain the 136 complete data sets required to provide 80% power to detect a clinically meaningful increase in daily PA of 1000 steps/day. Repeated measures ANOVA will evaluate study group impact (control/intervention) on pedometer steps. Secondary ANCOVA models will adjust for age, sex, treatment history and clinic site (Ottawa, London, Edmonton).

Our research team combines expertise in clinical intervention trials (Longmuir) and study design and analyses (Willan) with patient (Graham) & family (Rouble) experience plus > 60 years of clinical expertise (Lougheed, Norozi, Mackie). All investigators have previous experience leading multi-site research projects and supervising graduate students. Graham (Can. Congenital Heart Alliance) will ensure intervention relevance and scalability to all Canadian CHD patients. CHEO Family Forum (Rouble) will provide parent input. Through this study, we will advance knowledge of healthy, active lifestyles & PA support for CHD patients & the health system impacts of current practice recommendations to promote PA to CHD patients at every clinical encounter.

Conditions

Congenital Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Physical activity counselling during cardiac clinic visit with additional supports for community physical activity and access to a kinesiologist.

Group Type: EXPERIMENTAL

Physical activity counselling

Intervention Type: BEHAVIORAL

Clinician counselling about physical activity using standardized tools to promote daily physical activity.

Usual Care

Cardiac clinic visit with usual care but no physical activity counselling

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical activity counselling

Clinician counselling about physical activity using standardized tools to promote daily physical activity.

Intervention Type: BEHAVIORAL

Other Intervention Names

PA counselling

Eligibility Criteria

Inclusion Criteria

• All patients 5 to 17 years with CHD diagnoses classified as moderate or severe in complexity by the American College of Cardiology / American Heart Association joint guidelines.

Exclusion Criteria

• Cardiac intervention (catheterization or surgery) in preceding 6 months. Syndrome/diagnosis affecting physical activity (e.g., developmental disability) or the ability to complete the assessment questionnaires.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stollery Children's Hospital

OTHER

Sponsor Role: collaborator

London Health Sciences Centre

OTHER

Sponsor Role: collaborator

CHEO Family Forum

UNKNOWN

Sponsor Role: collaborator

Canadian Congenital Heart Alliance

OTHER

Sponsor Role: collaborator

Ontario Child Health Support Unit

UNKNOWN

Sponsor Role: collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Dr. Pat Longmuir

Scientist, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Longmuir, PhD

Role: PRINCIPAL_INVESTIGATOR

Scientist

Locations

Stollery Children's Hospital

Edmonton, Alberta, Canada

London Health Sciences Centre

London, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Countries

Canada

References

Longmuir PE, Lougheed J, Mackie AS, Norozi K, Yaraskavitch J, Chappell A, Dempsey A, Blais A, Foshaug R, Willan A, Graham J. In-Clinic Activity Promotion for Children With Congenital Heart Disease: Randomized Clinical Trial. CJC Pediatr Congenit Heart Dis. 2025 Feb 5;4(3):150-159. doi: 10.1016/j.cjcpc.2025.01.003. eCollection 2025 Jun.

Reference Type: DERIVED

PMID: 40933783 (View on PubMed)

Other Identifiers

17/191X

Identifier Type: -

Identifier Source: org_study_id