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Completed

NCT Number: NCT06535971

Individualized Exercise Combined With Manual Therapy 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.

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Key information

Conditions

Severe Hemophilia Behavior Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Motor Activity

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Far Eastern Memorial hospital

New Taipei City, 220, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual therapy combined exercise

Other
  • 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)

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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).

Secondary outcomes

  1. Daily notes

    Time frame: once a week (each intervention) for 3 months

    record each intervention, such as manual therapy and exercise

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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