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

Hemophilia A Clinical Trial

— HEPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199717
• Other study ID #: 1000039947
• Status: Completed
• Phase: N/A
• First received: July 23, 2014
• Last updated: December 8, 2016
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2016
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years to 17 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Factor IX Deficiency
• Factor VIII Deficiency
• Hemophilia A
• Hemophilia B

Intervention

Device:
• Accelerometer

Locations

Country	Name	City	State
Canada	SickKids	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Hemophilia Society

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MVPA	To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.	7 days	No
Primary	Sedentary Time	To determine if the amount of time spent in sedentary time on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.	7 days	No