Individualized Exercise Combined With Manual Therapy in Severe Hemophilia Patients With Polyarthropathy
- Conditions
- Severe Hemophilia
- Interventions
- Other: Manual therapy combined exercise
- Registration Number
- NCT06535971
- Lead Sponsor
- Far Eastern Memorial Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- over 20 years old and diagnosed with severe hemophilia
- those who receive prophylaxis regularly
- there are more than 2 target joints (hemophilic arthropathy)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Physiotherapy group Manual therapy combined exercise Individualized physiotherapy intervention based on manual therapy and exercise 1 session per week for 3 months
- Primary Outcome Measures
Name Time Method Hemophilia Joint Health Score (HJHS) 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 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 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) 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) 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.
- Secondary Outcome Measures
Name Time Method Daily notes once a week (each intervention) for 3 months record each intervention, such as manual therapy and exercise
Trial Locations
- Locations (1)
Far Eastern Memorial hospital
🇨🇳New Taipei City, Taiwan