Clinical trial NCT02199717: An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia
Official title: An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Hemophilia B
Factor VIII Deficiency
Factor IX Deficiency
Keywords: Physical Activity
Accelerometer
Exercise
Obesity
BMI
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Hemophilia Society
First posted: 2014-07-24
Enrollment: 66
Sex: MALE
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be 5 to 18 years of age with a diagnosis of hemophilia with no history of inhibitors or pre-existing co-morbidity (e.g. cerebral palsy, chronic respiratory conditions, congenital heart defects) that can affect activity participation.

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).

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.

Primary outcomes:
measure: MVPA
timeFrame: 7 days
measure: Sedentary Time
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: SickKids
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Vanessa Bouskill, NP, MN
role: PRINCIPAL_INVESTIGATOR
References: