- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02199717
An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia (HEPS)
December 8, 2016 updated by: Vanessa Bouskill, The Hospital for Sick Children
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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).
Study Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5G1X8
- SickKids
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Boys with Hemophilia
Accelerometer use for 1 week.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
7 days
|
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.
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7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Vanessa Bouskill, NP, MN, The Hospital For Sick Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
July 23, 2014
First Submitted That Met QC Criteria
July 23, 2014
First Posted (Estimate)
July 24, 2014
Study Record Updates
Last Update Posted (Estimate)
December 14, 2016
Last Update Submitted That Met QC Criteria
December 8, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000039947
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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