An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia

NCT ID: NCT02199717

Last Updated: 2016-12-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-09-30

Brief Summary

This pilot project was developed to investigate subjective and objective data related to the patterns of physical activity participation among hemophilia patients (FVIII or FIX) between the ages of 5 and 18 years. Physical activity participation among different levels of disease severity will be compared using accelerometers to calculate the amount of time spent in moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA; additionally, data will be collected from two validated questionnaires (PedHAL and 3 day physical activity recall). Current literature that relates level of physical activity to disease severity in the pediatric hemophilia population is limited. The information gained about the type and quantity of physical activity participation in children with varying levels of hemophilia will assist in the development of education and interventions to promote good physical activity and potentially examine the role of tailored prophylaxis.

Detailed Description

Objectives:

1. To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.

2. To determine if recorded physical activities and intensity of activities from self-report questionnaires (PedHAL and 3 day physical activity recall - 3DPAR) differ according to the severity of hemophilia.

3. To determine if, among patients with hemophilia, there is a relationship between physical activity level and patient age, weight, and body mass index (BMI).

Specific Aims:

•Aim # 1: The primary aim of the study is to determine if there are differences in the amount of time spent in MVPA by level of disease severity of children with hemophilia.

Secondary Aims:

• Aim # 2: To determine if there are meaningful differences in the accumulation of MVPA (bouts of exercise) by disease severity of children with hemophilia.
• Aim # 3: The compare the findings from Aim #1 and #2 to the NHANES (National Health and Nutrition Examination Survey) data, recognizing that this survey provides a comparative healthy normal cohort.
• Aim # 4: To investigate MVPA with these data collected from the PedHAL (11) and the 3DPAR (12) by disease severity of children with hemophilia.
• Aim # 5: The review and determine the relationship between physical activity participation and timing of prophylaxis factor replacement and whether participation is limited to days of factor infusion.
• Aim #6: To investigate the amount of physical activity and how it relates to age, weight, and patient body mass index (BMI).

Conditions

Hemophilia A; Hemophilia B; Factor VIII Deficiency; Factor IX Deficiency

Keywords

Physical Activity; Accelerometer; Exercise; Obesity; BMI

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Boys with Hemophilia

Accelerometer use for 1 week.

Accelerometer

Intervention Type: DEVICE

Interventions

Accelerometer

Intervention Type: DEVICE

Other Intervention Names

ActiLife; Kinesoft

Eligibility Criteria

Inclusion Criteria

• 5-17 years of age, has a diagnosis of Hemophilia A or B.

Exclusion Criteria

• Muscle or joint bleed within 4 weeks of study.
• Pre-existing co-morbidities that would affect physical activity participation.
• Unable to cooperate with study protocol.
• Unable to speak, read, or understand English.

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

Sponsors

Canadian Hemophilia Society

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Vanessa Bouskill

Nurse Practitioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vanessa Bouskill, NP, MN

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

SickKids

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000039947

Identifier Type: -

Identifier Source: org_study_id