N/A
N=66
An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia
Hemophilia A · Hemophilia B · Factor VIII Deficiency · Factor IX Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT02199717 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: MVPA — 48; 55 minutes per day — p=0.32
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Accelerometer (Device)
- Age
- Pediatric · 5+ yrs
- Sex
- Male
- Sponsor
- The Hospital for Sick Children
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MVPA |
48; 55 | 0.32 |
| PRIMARY Sedentary Time |
633.4; 327 | <0.01 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02199717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.