Factor IX Deficiency, Factor VIII Deficiency, Hemophilia A, Hemophilia B
Conditions
Keywords
Physical Activity, Accelerometer, Exercise, Obesity, BMI
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).
Interventions
DEVICEAccelerometer
Sponsors
Canadian Hemophilia Society
The Hospital for Sick Children
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
5 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MVPA | 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 | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Boys With Hemophilia | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | Boys With Hemophilia |
|---|---|
| Age, Customized <=18 years | 66 participants |
| Age, Customized >=65 years | 0 participants |
| Age, Customized Between 18 and 65 years | 0 participants |
| BMI Mild/Moderate Hemophilia | 21.93 kg/m2 STANDARD_DEVIATION 5.34 |
| BMI Severe Hemophilia | 20.05 kg/m2 STANDARD_DEVIATION 5.82 |
| On demand or Prophylaxis Regimen Mild/Moderate Hemophilia On demand | 19 Participants |
| On demand or Prophylaxis Regimen Mild/Moderate Hemophilia On prophylaxis | 5 Participants |
| On demand or Prophylaxis Regimen Severe Hemophilia On demand | 0 Participants |
| On demand or Prophylaxis Regimen Severe Hemophilia On prophylaxis | 42 Participants |
| Region of Enrollment Canada | 66 participants |
| Severity of Hemophilia Mild/Moderate | 24 Participants |
| Severity of Hemophilia Severe | 42 Participants |
| Sex/Gender, Customized Female | 0 Participants |
| Sex/Gender, Customized Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 |
Outcome results
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.
Time frame: 7 days
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Severe Hemophilia | MVPA | 48 minutes per day | Standard Deviation 20 |
| Mild/Moderate Hemophilia | MVPA | 55 minutes per day | Standard Deviation 18 |
Comparison: 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 (mild/moderate versus severe haemophilia) were examined in exploratory analyses.p-value: 0.32Wilcoxon (Mann-Whitney)
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.
Time frame: 7 days
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Severe Hemophilia | Sedentary Time | 633.4 minutes per day | Standard Deviation 121.3 |
| Mild/Moderate Hemophilia | Sedentary Time | 327 minutes per day | Standard Deviation 78.73 |
p-value: <0.0195% CI: [254.8, 358]Wilcoxon (Mann-Whitney)