Clinical trial NCT06535971: Individualized Exercise Combined With Manual Therapy in Severe Hemophilia Patients With Polyarthropathy
Official title: Effects of Individualized Exercise Intervention Combined With Manual Therapy on Musculoskeletal System, Cardiopulmonary Endurance and Quality of Life in Severe Hemophilia Patients With Polyarthropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Hemophilia
Keywords: Physiotherapy
Manual therapy
Exercise
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* over 20 years old and diagnosed with severe hemophilia
* those who receive prophylaxis regularly
* there are more than 2 target joints (hemophilic arthropathy)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hemophilia Joint Health Score (HJHS)
timeFrame: before intervention (baseline), after intervention 6th week and 12th week
measure: Visual Analogue Scale (VAS)
timeFrame: before intervention (baseline), after intervention 6th week and 12th week
measure: 6 minute walk test
timeFrame: before intervention (baseline), after intervention 6th week and 12th week
measure: Hemophilia Activity List (HAL)
timeFrame: before intervention (baseline), after intervention 6th week and 12th week
measure: EQ-5D-5L
timeFrame: before intervention (baseline), after intervention 6th week and 12th week
Secondary outcomes:
measure: Daily notes
timeFrame: once a week (each intervention) for 3 months
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial hospital
Study officials:
affiliation: staff
name: Wan Jung Kao, bachelor
role: PRINCIPAL_INVESTIGATOR
References: