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

NCT06535971 | Completed

• 2 other identifiers: 111296-EFarEasternMH
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Hemophilia

Keywords

Physiotherapy; Manual therapy; Exercise

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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).

  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.

  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).

  before intervention (baseline), after intervention 6th week and 12th week

Secondary Outcomes (1)

• Daily notes

  once a week (each intervention) for 3 months

Study Arms (1)

Physiotherapy group

OTHER

Individualized physiotherapy intervention based on manual therapy and exercise 1 session per week for 3 months

Other: Manual therapy combined exercise

Interventions

Manual therapy combined exercise OTHER

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)

Physiotherapy group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Hemophilia A; Motor Activity

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Officials

• Wan Jung Kao, bachelor

  staff

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 2, 2024
• Study Start: July 5, 2024
• Primary Completion: June 28, 2025
• Study Completion: December 31, 2025
• Last Updated: March 2, 2026

Record last verified: 2025-08

Locations

TW (1)