Individualized Exercise Combined With Manual Therapy in Severe Hemophilia Patients With Polyarthropathy

February 26, 2026 updated by: Far Eastern Memorial Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Physiotherapy group
Individualized physiotherapy intervention based on manual therapy and exercise 1 session per week for 3 months
Other: Manual therapy combined exercise
  1. 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before intervention (baseline), after intervention 6th week and 12th week
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).
before intervention (baseline), after intervention 6th week and 12th week
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).
before intervention (baseline), after intervention 6th week and 12th week
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.
before intervention (baseline), after intervention 6th week and 12th week
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).
before intervention (baseline), after intervention 6th week and 12th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily notes
Time Frame: once a week (each intervention) for 3 months
record each intervention, such as manual therapy and exercise
once a week (each intervention) for 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Investigators

  • Principal Investigator: Wan Jung Kao, bachelor, staff

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2024

Primary Completion (Actual)

June 28, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111296-E
  • FarEasternMH (Registry Identifier: WJKao)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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