Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia:a Prospective Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- 6 Minutes Walking Test
研究概览
简要总结
The present study aims to evaluate the modification of functional capacity induced by an adapted physical activity program in subjects with haemophilia.
The exercise program used aims to improve joint mobility, muscle strength, static and dynamic balance, motor coordination.
The program is structured in 1 hour sessions of 2 days/week and lasts 6 months.
The primary endpoint is the change in functional capacity calculated as the difference between the baseline assessment and the 3 and 6 month assessment of the 6 Minutes Walking Test measured with the G-Walk (BTS Bioengineering S.p.A).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hemophilia A or B;
- •Signature of informed consent;
- •Availability of a medical certificate for non-competitive activities
排除标准
- •Active bleeding
- •Severe joint deformities that prevent exercise
- •Insufficiency of communicative and/or sensory functions so severe that it is impossible to understand or carry out the trainer's instructions (dementia, aphasia, blindness, deafness)
- •Heart failure (NYHA class > 2)
- •Unstable angina
- •Lung disease requiring oxygen therapy
- •Symptomatic peripheral arterial disease
- •Myocardial infarction or hospitalization within the previous 6 months
- •Symptomatic orthostatic hypotension
- •Hypertension in poor pharmacological control (diastolic> 95 mmHg, systolic> 160 mmHg)
- •Significant neurological conditions that impair motor or cognitive function
研究组 & 干预措施
patients
patients with emophilia receiving a program of adapted physical activity
干预措施: AFA (Adapted Physical Activity) (Other)
结局指标
主要结局
6 Minutes Walking Test
时间窗: baseline,3 months,6 months
The change in functional capacity calculated as the difference between the baseline 6 Minutes Walking Test assessment and the 3 and 6 month assessment measured with the G-Walk (BTS Bioengineering S.p.A).
次要结局
- Functional Independence Score in Hemophilia (FISH)(baseline,3 months,6 months)
- Hemophilia joint health score (HJHS)(baseline,3 months,6 months)
- Tampa Scale of Kinesiophobia - (TSK)(baseline,3 months,6 months)
- Hemophilia Activity List (HAL)(baseline,3 months,6 months)
- Balance - Single leg stand test(baseline,3 months,6 months)
- Balance - Time Up and Go (TUG)(baseline,3 months,6 months)
- Pain (VAS - Visual Analogue Scale )(baseline,3 months,6 months)
- Muscle strenght- 30" Chair stand test(baseline,3 months,6 months)
- Muscle strenght-Arm curl test(baseline,3 months,6 months)
- Muscle strenght- Hand held measuring of hip and knee flexors/extensors(baseline,3 months,6 months)