Physical Activity in Fontan Patients

NCT00363363 | Completed Phase 3 DMC

• 1 other identifier: 1000008413
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine which is the most effective intervention for increasing lifestyle physical activity in Fontan patients: an education (stage of change) intervention or a physical activity (mastery experience) intervention.

Conditions

Heart Defects, Congenital

Keywords

Pediatrics; Fontan Procedure; Physical Activity; Physical Fitness; Congenital Heart Defects; exercise rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in the child's moderate-to-vigorous physical activity participation

  From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

Secondary Outcomes (4)

• Increase in health-related physical fitness

  From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

• Achievement of age-appropriate gross motor skills

  From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

• Change in the parents' and child's perceptions of physical activity importance, value, appropriateness and competence

  From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

• Compliance with the intervention

  From baseline to end of treatment (12 months) and follow up (6-12 months post-treatment)

Study Arms (2)

1

EXPERIMENTAL

Behavioral: Physical Activity

2

ACTIVE COMPARATOR

Behavioral: Education

Interventions

Physical Activity BEHAVIORAL

Children in this arm of the study will be provided with specific activities to be completed on most days of the week. The selected activities will be based on the child's interests and results of the baseline measures of health-related PA, MVPA and gross motor skill. The resources and facilities available to the family and season of the year will also influence the choice of activities. The frequency and duration of the required activities will be gradually increased until the child's baseline MVPA has been increased by a minimum of 30 minutes per day, most days of the week. Once that increase is achieved, the activities will be modified to maintain and reinforce the higher PA level.

1

Education BEHAVIORAL

Children in this arm of the study will be provided with puzzles, stories and games to be completed each week. The selected activities will be based on the child's interests and designed to increase the child's knowledge of activity options, perceptions of activity benefits, self-confidence for activity participation and motivation for daily activity. The activities introduced will vary with the resources available to the family and the season of the year, and will include information about healthy eating, injury prevention, and healthy lifestyle options.

2

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• have undergone a successful Fontan procedure prior to 5 years of age
• to 10 years of age at the start of the study
• sufficient cardiopulmonary function (based on pulmonary function tests prior to the standardized cardiorespiratory exercise test) for safe participation in moderate to vigorous physical activity

You may not qualify if:

• disabilities or medical conditions that may influence physical activity participation.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Motor Activity

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Brian McCrindle, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: August 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: May 1, 2009
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

CA (1)