Effectiveness of an Educational Physiotherapy and Home Exercises Program in Adult Patients With Hemophilia: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Change from baseline physical condition of joints after treatment and at 6 months
研究概览
简要总结
Although arthropathy is a serious problem in patients with hemophilia due to the associated morbidity and incapacity, to the best of the investigators knowledge, no studies have looked at the effect of educational physiotherapy for its clinical improvement.
This contribution presents the results of educational physiotherapy program applied for 15 weeks with home exercises - in patients with hemophilic arthropathy. After treatment, experimental group showed improved a significant reduction of pain, and best quality of life al illness behaviour. During treatment no patient showed elbow haemarthrosis, which underlines the safety of this physiotherapy program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with hemophilia A or B
- •Patients over 18 years
- •Patients with hemophilic arthropathy with at least 1 involved joint (elbow, knee or ankle)
- •having signed the informed consent document.
排除标准
- •Patients diagnosed with other congenital bleeding disorders (i.e. von Willebrand disease)
- •Patients who developed antibodies to FVIII or FIX (inhibitors)
- •Those not able to ambulate as a result of hemophilic arthropathy or any other disability
结局指标
主要结局
Change from baseline physical condition of joints after treatment and at 6 months
时间窗: Screening visit, within the first seven days after treatment and after six months follow-up visit
The physical condition of joints was assessed using the Gilbert scale that measures swelling, muscle atrophy, joint crepitus, range of motion, axial deformity and instability. Scores range from 0 to 12 (0 represents no joint injury and 12 represents maximum joint deterioration).
Change from baseline joint pain after treatment and at 6 months
时间窗: Screening visit, within the first seven days after treatment and after six months follow-up visit
Joint pain was assessed using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain at all) to 10 (the worst pain imaginable by the patient).
Change from baseline perception of the quality of life after treatment and at 6 months
时间窗: Screening visit, within the first seven days after treatment and after six months follow-up visit
The Haemophilia A-36 questionnaire was used to assess the perception of the quality of life. This questionnaire consists of 36 items that assess 9 domains (physical health, daily activities, joint damage and pain, treatment satisfaction, treatment difficulties, emotional functioning, mental health and social relationships).
Change from baseline illness behavior after treatment and at 6 months
时间窗: Screening visit, within the first seven days after treatment and after six months follow-up visit
To assess illness behavior, patients completed the Illness Behavior Questionnaire (IBQ). This scale consists of 62 items and 8 domains (hypochondriasis, disease conviction, psychological vs. somatic perception of illness, affective inhibition, affective disturbance, denial and irritability).
Change from baseline frequency of bleedings after treatment and at 6 months
时间窗: Screening visit, within the first seven days after treatment and after six months follow-up visit
The frequency of bleeding is measured with a record which complete the patients, where they indicate the incidence of hematomas and hemarthrosis during the treatment and follow-up.
次要结局
- Radiological joint deterioration(Screening visit)
- Age(Screening visit)
- Weight(Screening visit)
- Height(Screening visit)