Therapeutic Exercise: Does it Improve Pain Perception, Range of Movement and Quality of Life in Patients With Hemophilia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Pressure pain threshold (PPT) in the evaluated muscles.
研究概览
简要总结
Objectives: To assess the efficacy of performing a therapeutic exercise program, compared with usual care, on pain relief, range of movement and self-perceived quality of life in patients with hemophilia
Design: Quantitative, experimental, longitudinal and prospective study.
Subjects: Male patients between 30 and 45 years old, with hemophilia type A or B and with knee, ankle or elbow arthropathy caused by hemophilia. Participants may be undergoing a pharmacologic treatment with intravenous VIII and/or IX factor
Methods: Participants in the experimental group will an intervention based on therapeutic exercise. One therapist will instruct the patients during two sessions (each lasting approximately 1 hour). Participants will be asked to continue this program at least twice a week. Meanwhile, those in the control group will receive usual physical therapy care, based on a more passive approach, including self-assisted joint mobilization and muscle stretching. Those in the control group will be also instructed to perform the protocol at home, at least twice a week. The intervention protocol in both groups will last three months
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of hemophilia type A or hemophilia type B.
- •Knee, elbow or ankle arthropathy caused by hemophilia
- •Pharmacological treatment based on using VIII or IX factor concentrates.
排除标准
- •Presence of VIII FIX inhibitors.
- •Having received anti-inflammatory treatment using Arcoxia (Etoricoxib)
- •Having undergone a surgical intervention at the target joint.
- •Patients enrolled in other research which implies doing physical exercise.
结局指标
主要结局
Pressure pain threshold (PPT) in the evaluated muscles.
时间窗: Change from baseline to 3 months after intervention
The PPT levels will be evaluated in KPa. PPT levels, defined as the minimum necessary pressure to evoke pain will be evaluated using a handheld electronic pressure algometer.
Daily life activities
时间窗: Change from baseline to 3 months after intervention
Ordinary daily life activities will be assessed using the Haemophilia Activities List, which measures the self-perceived functional state.
Self-perceived quality of life: A36 Haemophilia-QoL test
时间窗: Change from baseline to 3 months after intervention
Quality of life will be evaluated using the A36 Haemophilia-QoL test. This is a valid and specific tool for hemophiliac adults.
Self-reported pain intensity: Numeric Pain Rating Scale (NPRS)
时间窗: Change from baseline to 3 months after intervention
Self-reported pain will be evaluated using the Numeric Pain Rating Scale (NPRS), where 0 denotes no pain at all, and 10 denotes the maximum possible pain.
General flexibility
时间窗: Change from baseline to 3 months after intervention
General flexibility will be assessed using the improved tot-flex test, which makes possible to extrapolate general flexibility from a combined movement measure.
Range of movement (ROM).
时间窗: Change from baseline to 3 months after intervention
Active ROM of the affected joint will be evaluated using inertial sensors, that measure lineal acceleration and angular velocity.
次要结局
未报告次要终点
研究者
Alberto Marcos Heredia-Rizo
Assistant Professor. Physiotherapy Department
University of Seville