A Feasibility Study of Physical Activity After Surgical or Catheterization Intervention

NCT04619745 | Completed

• 1 other identifier: 20/67X
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility study will assess whether a 6-month, home-based, parent-led physical activity program, completed after surgical or catheterization treatment, enables young children with congenital heart defects (CHD) to achieve the recommended 180 minutes of daily physical activity. This study includes comprehensive measures of motor skill and physical activity, intervening at a very young age, and targeting the high risk status for sedentary lifestyles of children with CHD. This study will provide essential data on patient recruitment, data collection procedures, the proposed physical activity intervention and resources required to enable the design of a randomized controlled trial (RCT) to evaluate play-based, parent-delivered interventions optimized to support age-appropriate physical activity and motor skills among young children with CHD.

Conditions

Congenital Heart Defect

Outcome Measures

Primary Outcomes (3)

• Feasibility of patient recruitment measured as # surgical patients, # cath patients, # eligible, # approached, # willing to enroll, # withdrawn

  Monthly: # surgical patients, # cath patients, # eligible, # approached, # willing to enroll, # withdrawn

  18 months

• Feasibility of patient randomization measured as # of patients/parents willing to randomize

  Monthly: # of patients/parents willing to randomize

  18 months

• Feasibility of data collection procedures measured as % of patients with complete pretreatment data

  % of patients with complete pretreatment data; days available prior to treatment for baseline data collection; % of parents able to complete child accelerometer wear for 7 days; % of control and intervention who complete all data sessions; frequency of missing data

  18 months

Secondary Outcomes (2)

• Retention and follow up rates measured as # participants retained in study; # follow up sessions complete

  18 months

• % compliant with intervention and rate of adherence

  18 months

Other Outcomes (5)

• Clarity of inclusion/exclusion criteria measured as # requiring MD consult for eligibility

  18 months

• healthcare professionals facilitate recruitment measured as # of days for MD approval

  18 months

• study time and burden measured as parent rating of time and burden (100mm visual analogue scale)

  18 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

All children enrolled in the study will complete five study visits. All participants will complete all outcome measures (including surveys, questionnaires, and motor skill assessments) at or after each 1-hour assessment visit. Children will be given an omni-directional accelerometer to wear on a waist-worn belt for 7 days after each visit to assess daily physical activity. The intervention group will complete individualized, parent-led, home and play-based activity plans for 6 months, beginning as soon as the child returns to the inpatient unit. The activities in the plan will be tailored to each phase of treatment (in hospital, discharge to week 7, week 8 to 6 months), follow a standardized format and provide content individualized to each child's age and previous visit assessments.

Other: Individualized Home and Play-Based Physical Activity Plans

Wait List Control Group

EXPERIMENTAL

All children enrolled in the study will complete five study visits. After the first visit is complete, children will be randomized to either the intervention or wait-list control study group. Control participants will follow the same schedule of assessments at each visit, but the intervention will be provided between the 12-month and 16-month assessments. All participants will complete all outcome measures (including surveys, questionnaires, and motor skill assessments) at or after each 1-hour assessment visit. Children will be given an omni-directional accelerometer to wear on a waist-worn belt for 7 days after each visit to assess daily physical activity.

Other: Individualized Home and Play-Based Physical Activity Plans

Interventions

Individualized Home and Play-Based Physical Activity Plans OTHER

Play-based, parent led interventions optimized to support age appropriate physical activity, and motor skills among young children with congenital heart defects.

Intervention Group; Wait List Control Group

Eligibility Criteria

• Age: 3 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Female or male at least 3 months of age but not more than 72 months of age (upper age limit for valid Peabody Motor Development Scales-2 assessment)
• Receiving elective treatment via cardiac surgery or catheterization intervention for CHD at the Children's Hospital of Eastern Ontario.

You may not qualify if:

• Genetic conditions or physical disabilities impacting motor development (e.g., Down syndrome)
• Emergency treatment for child in critical condition
• Medical care not compatible with study assessments
• No independent limb movement.

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (11)

• Ginsburg KR; American Academy of Pediatrics Committee on Communications; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health. The importance of play in promoting healthy child development and maintaining strong parent-child bonds. Pediatrics. 2007 Jan;119(1):182-91. doi: 10.1542/peds.2006-2697.

  PMID: 17200287 BACKGROUND

• Bar-Or O, Rowland TW. Habitual activity and energy expenditure in the healthy child. Pediatric Exercise Medicine: From Physiologic Principles to Health Care Application. Champaign, IL: Human Kinetics; 2004. p. 64-7.

  BACKGROUND

• Klavora P. Foundations of Exercise Science. Toronto, Ontario: Sport Books Publisher; 2004.

  BACKGROUND

• Centers for Disease Control. Physical activity for everyone: The importance of physical activity. 2005; Available at: URL: http://www.cdc.gov/nccdphp/dnpa/physical/importance/index.htm. Accessed August 9, 2007.

  BACKGROUND

• Timmons BW, Naylor PJ, Pfeiffer KA. Physical activity for preschool children--how much and how? Can J Public Health. 2007;98 Suppl 2:S122-34.

  PMID: 18213943 BACKGROUND

• Longmuir PE, McCrindle BW. Physical activity restrictions for children after the Fontan operation: disagreement between parent, cardiologist, and medical record reports. Am Heart J. 2009 May;157(5):853-9. doi: 10.1016/j.ahj.2009.02.014.

  PMID: 19376311 BACKGROUND

• Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.

  PMID: 11468499 BACKGROUND

• Project DATA. Social Skills Checklist. 2007. St. Louis, University of Washington. 7-20-2019. Ref Type: Serial (Book,Monograph)

  BACKGROUND

• Abidin RR. Parenting Stress Index. 3rd ed. Odessa, Florida: Psychological Assessment Resources, Inc.; 1990.

  BACKGROUND

• Stieber NA, Gilmour S, Morra A, Rainbow J, Robitaille S, Van Arsdell G, McCrindle BW, Gibson BE, Longmuir PE. Feasibility of improving the motor development of toddlers with congenital heart defects using a home-based intervention. Pediatr Cardiol. 2012 Apr;33(4):521-32. doi: 10.1007/s00246-011-0144-0. Epub 2011 Nov 25.

  PMID: 22116604 BACKGROUND

• Ramanan N, Lee S, Maharajh G, Webster R, Longmuir PE. Preventing sedentary lifestyles among young children born with congenital heart defects: A feasibility study of physical activity rehabilitation after surgical or catheterization intervention. PLoS One. 2023 Aug 18;18(8):e0284946. doi: 10.1371/journal.pone.0284946. eCollection 2023.

  PMID: 37594946 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A graduate student, blind to study group allocation, will conduct all assessments at each visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: In this model there is an intervention group and a wait-list control group. The intervention group will be receiving a 6-month, home-based, parent-led physical activity program, where as the control group will not receive this intervention until after the 12-month assessment.

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: November 6, 2020
• Study Start: November 1, 2020
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)