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| Name | Class |
|---|---|
| Canadian Hemophilia Society | OTHER |
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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.
Objectives:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boys with Hemophilia | Accelerometer use for 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerometer | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Bouskill, NP, MN | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SickKids | Toronto | Ontario | M5G1X8 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Boys With Hemophilia | Use of accelerometer for 1 week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
42 boys with severe hemophilia 24 boys with moderate/mild hemophilia
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| ID | Title | Description |
|---|---|---|
| BG000 | Boys With Hemophilia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses. | Posted | Mean | Standard Deviation | minutes per day | 7 days |
|
Adverse events were documented for the duration of study for each participant (duration being 1 week).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Severe Hemophilia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Bouskill NP | Hospital for Sick Children | 4168135871 | vanessa.bouskill@sickkids.ca |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| D009043 | Motor Activity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| participants |
|
| Sex/Gender, Customized | All male | Number | Participants |
|
| Region of Enrollment | SickKids catchment area | Number | participants |
|
| BMI | BMI was grouped by hemophilia severity. | Mean | Standard Deviation | kg/m2 |
|
| On demand or Prophylaxis Regimen | On demand (only treated for bleeds) Prophylaxis (treated to prevent bleeds from occuring) | Grouped by hemophilia severity. | Count of Participants | Participants |
|
| Severity of Hemophilia | Severe <1% FVIII (Factor 8 Deficiency/Hemophilia A) or FIX (Factor 9 Deficiency/Hemophilia B) Moderate/Mild >1% FVIII or FIX | Count of Participants | Participants |
|
Mild/Moderate Hemophilia
|
|
|
| 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. | All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses. | Posted | Mean | Standard Deviation | minutes per day | 7 days |
|
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|
|
| 0 |
| 66 |
| 0 |
| 66 |
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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |