Association Between Individual Clotting Factor Level Monitoring and the Risk of Bleeding Whilst Physical Active Conditions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total annual bleeding rate
研究概览
简要总结
The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically active
详细描述
In patients with haemophilia (PwH) repetitive joint bleedings result in a so called haemophilic arthropathy, which is often associated with chronic pain as well as functional restrictions.
Due to the opportunity of sufficient factor treatment regimes, physical activity is no longer considered as a risk factor for PwH. In contrast, the large amount of current scientific evidence demonstrated high benefits of regular exercising for PwH. Meanwhile, physical activity is integrated as recommendation in the ´Guidelines for the management of hemophilia´. Nevertheless, the detailed influence of the exact course of the individual clotting factor level corresponding to the intensity of physical activities in consideration of possible bleeding events in adult PwH have not been examined to date.
The aim of this prospective multicentre study is to evaluate the influence of individual clotting factor level while being physically activie. Hereby the focus is on haemophilic specific parameters such as bleeding events, factor treatment and pain. On the basis of this study, an individualized clotting factor level should be determined which ensures a minimized risk of a bleeding event, considering type and intensity of the exercises. In line with these new findings, further interventional studies could be initiated in order to safely enhance the degraded physical performance as well as quality of life in PwH.
The generated knowledge could be further used in the development of haemophilic specific recommendations regarding physical activity in consideration of the individual clotting factor level.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients suffering from moderate or severe hemophilia A (FVIII <5%, ≥ 12 years old)
- •factor treatment with ADVATE© or ADYNOVI©
- •use of myPKFiT
排除标准
- •patients suffering from other coagulopathies
- •participants without written consent
- •participants < 12 years old
- •joint surgery like arthroscopy, synovectomy up to six months before study
- •suffering from different rheumatologic diseases like M. Bechterew, Psoriasi or other local or generalized joint infections (Borreliosis, septic arthritis)
结局指标
主要结局
Total annual bleeding rate
时间窗: 12 months
Number of bleedings per year, documented in a digital template
Clotting factor VIII level
时间窗: 12 months
In percent, documented in "myPKFIT"
Type of physical activity documented in a digital template
时间窗: 12 months
PwH are used to document the type and intensity of their physical activity in terms of a digital template which will be electronically requested monthly by co-workers of this study
Physiological parameters (heart rate of PwH, measured with FitBit Charge 4 HR)
时间窗: 12 months
Individual type and intensity of physical activity measured as heart rate by an electronic activity wristband (Fitbit charge 4 HR, synchronized in corresponding FitBit Application) For the final evaluation, each physical activity will be clustered regarding type and intensity to differ between the specific demands of activity.
次要结局
- Factor substitution in international units(12 months)
- Score of subjective physical performance measured by the HEP-Test-Q(Baseline, after 6 and 12 months)
- Frequency of factor substitution(12 months)
- Score of subjective quality of life measured by the SF36 Health Survey(Baseline, after 6 and 12 months)
- Joint status in score points measured by Hemophilia Joint Health Score(Baseline, after 6 and 12 months)
- Pain status measured by the German Pain Questionnaire(Baseline, after 6 and 12 months)
- Pressure pain thresholds(Baseline, after 6 and 12 months)
研究者
Prof. Dr. Dr. Thomas Hilberg
Prof. Dr. med. Dr. phil.
University of Wuppertal