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临床试验/NCT02199717
NCT02199717已完成不适用

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

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Sedentary Time

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • 5-17 years of age, has a diagnosis of Hemophilia A or B.

排除标准

  • 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.

结局指标

主要结局

Sedentary Time

时间窗: 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.

MVPA

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanessa Bouskill

Nurse Practitioner

The Hospital for Sick Children

研究点 (1)

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