Severe HemophiliaNCT06535971
Individualized Exercise Combined With Manual Therapy in Severe Hemophilia Patients With Polyarthropathy
A study testing Manual therapy combined exercise in people with Severe Hemophilia, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Severe Hemophilia
- What is being tested?
- Manual therapy combined exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jul 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 20 years old and diagnosed with severe hemophilia
- those who receive prophylaxis regularly
- there are more than 2 target joints (hemophilic arthropathy)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Severe Hemophilia
- Being tested
- Manual therapy combined exercise
- Keywords
- Physiotherapy, Manual therapy, Exercise
- Medical subject headings
- Hemophilia A, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy combined exerciseOther
- Manual therapy included fascia release, progressive passive stretch, mobilization, etc.(depend on subject's current condition)
- Exercise included muscle strengthening, trunk (spine) stabilization exercise. (depend on subject's current condition)
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy group | Other | Individualized physiotherapy intervention based on manual therapy and exercise 1 session per week for 3 months Receives: Other: Manual therapy combined exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemophilia Joint Health Score (HJHS)
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.
Measured: before intervention (baseline), after intervention 6th week and 12th week
Visual Analogue Scale (VAS)
To assess the target joint pain in hemophilia. The minimum value is 0, and the maximum value is 10 (higher score is worse).
Measured: before intervention (baseline), after intervention 6th week and 12th week
6 minute walk test
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).
Measured: before intervention (baseline), after intervention 6th week and 12th week
Hemophilia Activity List (HAL)
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.
Measured: before intervention (baseline), after intervention 6th week and 12th week
EQ-5D-5L
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).
Measured: before intervention (baseline), after intervention 6th week and 12th week
Secondary outcomes (1)
Daily notes
record each intervention, such as manual therapy and exercise
Measured: once a week (each intervention) for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start5 Jul 2024
- Primary completion28 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe HemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wan Jung Kao, bachelor, Principal investigator, staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535971
- Sponsor's protocol ID
- 111296-E
- Other IDs
- FarEasternMH
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06535971
- Acronym / sponsor ID
- 111296-E
- Conditions
- Severe Hemophilia
- Keywords
- Physiotherapy, Manual therapy, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 28 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy group | Other | Other: Manual therapy combined exerciseIndividualized physiotherapy intervention based on manual therapy and exercise 1 session per week for 3 months |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 20 years old and diagnosed with severe hemophilia
- those who receive prophylaxis regularly
- there are more than 2 target joints (hemophilic arthropathy)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapy combined exercise1. Manual therapy included fascia release, progressive passive stretch, mobilization, etc.(depend on subject's current condition) 2. Exercise included muscle strengthening, trunk (spine) stabilization exercise. (depend on subject's current condition) | Other | Physiotherapy group |
Primary outcome
Hemophilia Joint Health Score (HJHS)
Time frame: 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.
Visual Analogue Scale (VAS)
Time frame: 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).
6 minute walk test
Time frame: 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).
Hemophilia Activity List (HAL)
Time frame: 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.
EQ-5D-5L
Time frame: 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).
1 secondary outcome
Daily notes
Time frame: once a week (each intervention) for 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan Jung Kao, bachelor principal investigator
staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy combined exercise in people with Severe Hemophilia, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemophilia Joint Health Score (HJHS) (time frame: before intervention (baseline), after intervention 6th week and 12th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.