Effectiveness of an Exercise Program to Improve Balance and Dual Task in Hemophilic Patients. Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change of postural balance: amplitude of Center of Pressure (CoP) displacements
研究概览
简要总结
This study evaluates the effectiveness of a program of physiotherapy exercises to train the balance and dual task in adults patients with hemophilia
详细描述
The objective of the study is to create an exercise program to improve the static and dynamic balance in hemophilic patient. In addition, the effect of the exercise program on dual task, functionality, proprioception, QoL, risk of falls and the kinesiophobia will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of haemophilia A or B
- •Willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations
- •Approval by their hematologist to participate in the exercise program
- •With hemostatic coverage supervised by your hematologist.
- •Age between 18 and 60 years
- •Informed consent signed.
排除标准
- •Non adherence to instruction on proper exercise technique
- •Surgical procedures performed 6 months prior to or during the exercise program
- •A major bleeding episode that posed a risk or prevented exercise
- •Need for major surgery
- •Suffer from dizziness
- •Withdrawal of informed consent
- •Acquired hemophilia
结局指标
主要结局
Change of postural balance: amplitude of Center of Pressure (CoP) displacements
时间窗: baseline and 3 months
Amplitude of CoP displacements will be assessed in millimeters using a computerized balance system. Higher displacements indicate worse balance.
Change of dual task balance: amplitude of Center of Pressure (CoP) displacements
时间窗: baseline and 3 months
Amplitude of CoP displacements will be assessed in millimeters using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher displacements indicate worse balance.
Change of postural balance: velocity of Center of Pressure (CoP) displacements
时间窗: baseline and 3 months
Velocity of CoP displacements will be assessed in millimeters using a computerized balance system. Higher velocity indicate worse balance.
Change of postural balance: sway area of Center of Pressure (CoP) displacements
时间窗: baseline and 3 months
Sway area of CoP displacements will be assessed in mm\^2 using a computerized balance system. Higher sway area indicate worse balance.
Change of dual task balance: velocity of Center of Pressure (CoP) displacements
时间窗: baseline and 3 months
Velocity of CoP displacements will be assessed in millimeters using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher velocity indicate worse balance.
Change of dual task balance: sway area of Center of Pressure (CoP) displacements
时间窗: baseline and 3 months
Sway area of CoP displacements will be assessed in mm\^2 using a computerized balance system. Patient will perform a cognitive task (e.g. counting) while maintaining balance. Higher sway area indicate worse balance.
次要结局
- Functional capacity: 2-minutes walk test(baseline and 3 months)
- Kinesiophobia(baseline and 3 months)
- Modified Falls Efficacy Scale (mFES)(baseline and 3 months)
- The Berg Balance Scale(baseline and 3 months)
- Functional capacity: The Timed "Up & Go" test(baseline and 3 months)
- Functional capacity: Sit-to-stand test(baseline and 3 months)
- Limits of Stability (LOS): success rate(baseline and 3 months)
- Limits of Stability (LOS): time(baseline and 3 months)
- Haemophilia Activities List (HAL)(baseline and 3 months)
- Functional Independence Scale for Hemophilia (FISH)(baseline and 3 months)
- Quality of Life related with health: questionnaire(baseline and 3 months)
- Joint health status(baseline)
研究者
Felipe Querol Fuentes
Principal Investigator
University of Valencia