Effects of Individualized Exercise Intervention Combined With Manual Therapy on Musculoskeletal System, Cardiopulmonary Endurance and Quality of Life in Severe Hemophilia Patients With Polyarthropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Hemophilia Joint Health Score (HJHS)
研究概览
简要总结
The aim of this study is to investigate the effect of individualized physical therapy, combined manual therapy and exercise intervention, for pain perception, range of motion (ROM), muscle strength, joint health, cardiopulmonary endurance and quality of life (QoL) in patients with severe hemophilia A and multiple hemophilic arthropathy.
详细描述
The main clinical manifestations of hemophilia are muscle and joint bleeding. Recurrent bleeding leads to a degenerative process known as hemophilic arthropathy. Past studies investigated the effect of manual therapy of exercise for individuals with hemophilia and found to enhance muscle strength, balance, fitness and promote quality of life. However, less study has evaluated the safety and effectiveness of manual therapy combined with exercise for individuals with multiple hemophilic arthropathy. Therefore, the aim of this study is to investigate the effect of individualized physical therapy, combined manual therapy and exercise intervention, for pain perception, range of motion (ROM), muscle strength, joint health, cardiopulmonary endurance and quality of life (QoL) in patients with severe hemophilia A and multiple hemophilic arthropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 20 years old and diagnosed with severe hemophilia
- •those who receive prophylaxis regularly
- •there are more than 2 target joints (hemophilic arthropathy)
排除标准
- •unwilling to sign the informed consent
- •any neurological disease or specific musculoskeletal condition (such as fracture) one year ago
- •more than 3 (excluding 3) joint replacement surgeries (different joints)
- •unable to walk due to hemophilia joint disease or any other diseases
- •major bleeding events that pose risks or hinder research
- •unable to follow instructions due to cognitive impairment
结局指标
主要结局
Hemophilia Joint Health Score (HJHS)
时间窗: before intervention (baseline), after intervention 6th week and 12th week
To measure joint health, in the domain of body structure and function (i.e. impairment), of the joints most commonly affected by bleeding in hemophilia: the knees, ankles, and elbows. It provides a total score (higher score is worse; max=124), joint specific scores, and a global gait score.
EQ-5D-5L
时间窗: before intervention (baseline), after intervention 6th week and 12th week
To measure the quality of life. Each dimension now has five response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), unable to/extreme problems (5). The minimum value is 55555 and the maximum value is 11111 (higher score is worse). EQ VAS：the minimum score is 0, and the maximum score is 100 (higher score is better).
6 minute walk test
时间窗: before intervention (baseline), after intervention 6th week and 12th week
To evaluate cardiopulmonary endurance. The predictive equation for males: 6MWD(m) = 867 - (5.71 age, yrs) + (1.03 height, cm). The predictive equation for females: 6MWD(m) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22BMI).
Visual Analogue Scale (VAS)
时间窗: before intervention (baseline), after intervention 6th week and 12th week
To assess the target joint pain in hemophilia. The minimum value is 0, and the maximum value is 10 (higher score is worse).
Hemophilia Activity List (HAL)
时间窗: before intervention (baseline), after intervention 6th week and 12th week
To measure the impact of hemophilia on self-perceived functional abilities in adults.Normalized scores for the domains, components, and the full questionnaire can also be obtained. Missing values are controlled for and the possible scores range from 0 to 100, where 0 represents the worst possible functional status and 100 the best possible functional status.
次要结局
- Daily notes(once a week (each intervention) for 3 months)