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

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.

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Key information

Conditions

Hemophilia A Behavior Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Body Weight Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Factor IX Deficiency Factor VIII Deficiency Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhagic Disorders Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–17 year

Sex eligibility

Male

Study type

Observational

Primary location

SickKids

Toronto, Ontario, M5G1X8, Canada

About this study

Objectives:

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.
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.
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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Accelerometer

Device

Other names: ActiLife, Kinesoft

Primary outcomes

MVPA

Time frame: 7 days

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.
Sedentary Time

Time frame: 7 days

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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

Canadian Hemophilia Society

Registry information

Acronym: HEPS

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2016
First posted: Jul 24, 2014
Registry last updated: Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed