Impact of Moderate to Vigorous-intensity Physical Activities on Pharmacokinetic-guided Extended Half-life FVIII Concentrates Prophylaxis Severe Hemophilia A Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- hemophilia Joint Health Scores (HJHS)
研究概览
简要总结
To compare clinical outcomes before and after using combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis in moderate to severe hemophilia A patients
详细描述
This is a prospective cohort study of severe hemophilia A patients receiving low-dose EHL FVIII concentrates with PK-guided EHL FVIII concentrates prophylaxis alone for 6 months. Additional exercise workshops from sport scientists were introduced individually to this group of patients along with using the same prophylaxis method for another period of 6 months. The annualized bleeding rates (ABR), the annualized joint bleeding rates (AJBR), the haemophilia-specific quality-of-life (Haemo-QoL-A) scores, the hemophilia Joint Health Scores (HJHS) and skeletal muscle mass were compared between these two periods
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Severe Hemophilia A patients
排除标准
- 未提供
研究组 & 干预措施
PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities
PK-guided EHL FVIII concentrates prophylaxis with moderate intensity physical activities
干预措施: combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis (Drug)
PK-guided EHL FVIII concentrates prophylaxis alone
PK-guided EHL FVIII concentrates prophylaxis alone
干预措施: pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone (Drug)
结局指标
主要结局
hemophilia Joint Health Scores (HJHS)
时间窗: 6 months
hemophilia Joint Health Scores (HJHS)
annualized bleeding rates (ABR)
时间窗: 6 months
annualized bleeding rates (ABR)
annualized joint bleeding rates (AJBR)
时间窗: 6 months
annualized joint bleeding rates (AJBR)
haemophilia-specific quality-of-life (Haemo-QoL-A) scores
时间窗: 6 months
haemophilia-specific quality-of-life (Haemo-QoL-A) scores
次要结局
未报告次要终点
研究者
Darintr Sosothikul
Associate Professor, Head of Integrative and Innovative Hematology/Oncology Research Unit at Faculty of Medicine, Chulalongkorn University.
Chulalongkorn University