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临床试验/NCT04181697
NCT04181697已完成不适用

The HemFitBit-study: Defining Normal Physical Activity in Haemophilia A

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Physical Activity (PA) volume

研究概览

简要总结

The study aims to describe physical activity (PA) levels in young people with haemophilia A in Norway compared with non-haemophilia controls, and to identify factors influencing PA. This will be conducted through an observational study measuring PA over 12 weeks. Forty young people with moderate and severe haemophilia A will be enrolled. PA data will be compared to demographically and seasonally matched non-haemophilia controls. PA will be measured using the activity tracker Fitbit Charge 3. A subgroup of participants will also wear the hip-worn accelerometer ActiGraph GTX+BT for seven consecutive days in order to validate the two devices against each other.

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
13 Years 至 30 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • moderate or severe haemophilia A
  • no inhibitor
  • on continuous prophylaxis

排除标准

  • current inhibitor

结局指标

主要结局

Physical Activity (PA) volume

时间窗: 9 months

PA volume in different intensities

Physical activity types

时间窗: 9 months

Self reported types of PA

Fulfilment of PA recommendations

时间窗: 9 months

Fulfilment of international PA recommendations

Trend in PA over time

时间窗: 9 months

Trend in PA and sedentary time over the study period

次要结局

  • Impact of haemophilia on daily life(9 months)
  • Health Related Quality of Life(9 months)
  • Joint score(9 months)
  • Ultrasound joint score(9 months)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pål Andre Holme

MD, PhD, Professor of Haematology

Oslo University Hospital

研究点 (1)

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