Protected by Nature: Could Physical Activity Help to Counteract the Blood Haemophilia Disturbance? A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Determine the acceptability of a 6-weeks endurance training program in patients with haemophilia A as assessed by specific clinical follow-up
研究概览
简要总结
Physical activity is lower in patients with haemophilia than in their healthy peers. Nevertheless, exercize is recommended for those patients and supported by evidence. Until 2013, scientific and medical evidence to encourage physical activity for patients with haemophilia were listed to increase their locomotor function, their metabolic status, their fitness level and their well-being. In 2013, an original publication by Groen et al. suggested that physical activity could also interact with the specific and biological disturbance of the disease.
We propose to consider that regular endurance exercize prescription should be encouraged in patients with haemophilia not only for a healthier lifestyle but also because it could positively alter the specific biological blood disturbance seen in haemophilia. Nevertheless, before planning a well powered intervention trial we need to determine the acceptability of regular exercize and the expected value of factor Factor VIII, von Willebrand factor and von Willebrand propeptide after an endurance training program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Mild (FVIII:1-5%) and moderate (FVIII:6-40%) haemophilia A patients,
- •Living in the Midi-Pyrenees region,
- •Between 18 and 45 years old,
- •Exempt from any significant medical condition that could prevent them from being subjected to an endurance training program,
- •Affiliated to a social security cover
排除标准
- •Subjects declaring 2 or more spontaneous bleeding events and/or 4 or more induced bleeding events out of a traumatic circumstance 6 months prior to inclusion
- •Absence of signed consent
- •Patient protected by Justice
研究组 & 干预措施
Haemophilia A patients
Patients will perform endurance training program on 6 consecutive weeks
干预措施: Endurance training program (Other)
结局指标
主要结局
Determine the acceptability of a 6-weeks endurance training program in patients with haemophilia A as assessed by specific clinical follow-up
时间窗: During 6 weeks
次要结局
- Variation of Factor VIII in response to acute exercise before and after the endurance training program as assessed by specific bioassay(Day 1 and after 6 weeks of training program)
- Variation of von Willebrand Factor in response to acute exercise before and after the endurance training program as assessed by specific bioassay(Day 1 and after 6 weeks of training program)
- Variation of von Willebrand propeptide in response to acute exercise before and after the endurance training program as assessed by specific bioassay(Day 1 and after 6 weeks of training program)
- Variation of maximal oxygen uptake in response to acute exercise before and after the endurance training program as assessed by specific endurance testing(Day 1 and after 6 weeks of training program)
- Variation of VO2max in response to acute exercise before and after the endurance training program as assessed by specific endurance testing(Day 1 and after 6 weeks of training program)
- Variation of quality of life of patients in response to acute exercise before and after the endurance training program as assessed by Haem-A-QoL questionnaire(Day 1 and after 6 weeks of training program)