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

NCT02199717 | Completed Results

• 1 other identifier: 1000039947
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia A; Hemophilia B; Factor VIII Deficiency; Factor IX Deficiency

Keywords

Physical Activity; Accelerometer; Exercise; Obesity; BMI

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Boys with Hemophilia

Accelerometer use for 1 week.

Device: Accelerometer

Interventions

Accelerometer DEVICE

Also known as: ActiLife, Kinesoft

Boys with Hemophilia

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• years of age, has a diagnosis of Hemophilia A or B.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Hemophilia Society: collaborator

Study Sites (1)

SickKids

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Hemophilia A; Hemophilia B; Motor Activity; Obesity

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vanessa Bouskill NP
• Organization: Hospital for Sick Children

vanessa.bouskill@sickkids.ca

4168135871

Study Officials

• Vanessa Bouskill, NP, MN

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practitioner

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 24, 2014
• Study Start: September 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2016
• Last Updated: December 14, 2016
• Results First Posted: December 14, 2016

Record last verified: 2016-12

Locations

CA (1)