Effects of COVID-19 Quarantine on the Musculoskeletal Status of Adult Hemophilia Patients. An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change from baseline frequency of hemarthrosis after confinement period
研究概览
简要总结
Background. The recurrence of hemarthrosis in patients with congenital coagulopathies favors the development of a progressive, degenerative and intra-articular lesion (hemophilic arthropathy) that mainly affects the knees, ankles and elbows. Pain is one of the main clinical manifestations of hemophilic arthropathy. As a consequence of the COVID-19 pandemic, the Government of Spain, among others, established a total confinement for two months, in order to avoid contagion of the population Objective. To assess the effect of COVID-19 confinement on bleeding frequency, pain perception, and range of motion in patients with hemophilic arthropathy.
Study design. Prospective observational study. Method. 27 patients with hemophilia A and B will be included in this study. Patients will be recruited from the Spanish Hemophilia Federation (Fishemo) specialized center for hemophilia patients. The dependent variables will be: the frequency of bleeding (through a self-report), the perception of pain (measured with the visual analog scale and a pressure algometer), the joint state (with the Hemophilia Joint Health Score), and the range of joint movement (measured with a goniometer). Two evaluations will be carried out: pre-treatment (carried out in the month of February, as a periodic evaluation) and post-treatment (at the end of the period of confinement in Spain).
Expected results. The aim is to observe the sequelae caused by confinement and a sedentary lifestyle in patients with hemophilic arthropathy, through changes in joint status, pain and range of motion.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients with medical diagnosis of hemophilia A or hemophilia B
- •Patients over 18 years of age
- •Patients in a prophylactic or on demand regimen with factor VIII / factor IX concentrates
- •Patients that have accepted the informed consent document.
排除标准
- •Patients with neurological or cognitive disorders that prevent the comprehension of the questionnaires
- •Patients without capacity to walk autonomously or with orthosis
- •Patients without access to digital media to complement the measuring instruments.
结局指标
主要结局
Change from baseline frequency of hemarthrosis after confinement period
时间窗: Screening visit, within the first seven days after confinement
The frequency of joint bleeding was assessed using a self-assessment log provided to patients at the beginning of confinement electronically. This registry included a monthly calendar where the patients included the date, symptoms and location of the hemarthrosis.
次要结局
- Change from baseline joint health after confinement period(Screening visit, within the first seven days after confinement)
- Change from baseline joint pain after confinement period(Screening visit, within the first seven days after confinement)
- Change from baseline range of motion after confinement period(Screening visit, within the first seven days after confinement)