NCT07523399

Brief Summary

Hemophilia is a hereditary bleeding disorder characterized by recurrent bleeding episodes, particularly into joints and muscles, leading to chronic musculoskeletal complications. Repeated joint bleeding may result in hemophilic arthropathy, which is associated with progressive joint damage, chronic pain, reduced mobility, and functional limitations. Advances in prophylactic treatment have significantly improved life expectancy in individuals with hemophilia; however, long-term musculoskeletal complications continue to affect daily functioning and overall well-being. Therefore, the evaluation of health-related quality of life (QoL) has become increasingly important in adults with hemophilia, as it reflects the broader impact of the disease beyond clinical severity. Joint health is considered one of the major determinants of physical functioning in people with hemophilia. Hemophilic arthropathy may lead to chronic pain, muscle weakness, reduced range of motion, and impaired physical performance. In addition to structural joint changes, impairments in neuromuscular function, including reduced proprioception, muscle strength, and postural control, may also contribute to activity limitations. Balance impairments may increase the risk of falls, which may be particularly relevant for individuals with hemophilia because fall-related trauma can lead to bleeding episodes and further joint deterioration. Although previous studies have investigated the relationship between joint health, pain, and functional limitations, the combined contribution of joint health, pain severity, dynamic balance performance, and fall history to QoL in adults with hemophilia has not been sufficiently clarified. This prospective cross-sectional study aims to evaluate QoL in adults with hemophilia and to investigate the associations of joint health, pain severity, dynamic balance performance, and fall history with QoL outcomes. The study includes 36 adults diagnosed with severe hemophilia A who are followed at the Adult Hematology Unit of Van Yuzuncu Yil University. Participants aged 18 years and older who met the inclusion criteria were recruited consecutively. Individuals using walking aids, having neurological or psychiatric disorders, chronic inflammatory diseases, recent lower extremity surgery, or regular medication use that could affect balance were excluded. Joint health is assessed using the Hemophilia Joint Health Score (HJHS), a clinician-administered tool evaluating joint impairment in the knees and ankles. Dynamic balance is assessed using a computerized stabilometric platform (Pro-kin Tecnobody Stabilometric Analysis System) with the Limits of Stability (LoS) test, which evaluates the ability to voluntarily control the center of pressure within the base of support. Pain intensity is measured using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 to 10. Fall history is determined based on the self-reported number of falls within the previous 12 months. QoL is assessed using the Turkish version of the Haemophilia-Specific Quality of Life Questionnaire for adults (Haem-A-QoL), a validated patient-reported outcome measure evaluating multiple domains of physical, emotional, and social well-being. Higher scores indicate poorer QoL. The findings of this study are expected to improve the understanding of factors associated with QoL in adults with hemophilia and may help identify potentially modifiable clinical targets for rehabilitation interventions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
0mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Feb 2026May 2026

Study Start

First participant enrolled

February 21, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2026

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 4, 2026

Last Update Submit

April 4, 2026

Conditions

Keywords

Quality of lifeHemophilia AArthropathyPostural balanceFallsMusculoskeletal Pain

Outcome Measures

Primary Outcomes (3)

  • Health-related quality of life

    Health-related quality of life will be assessed using the Haemophilia-Specific Quality of Life Questionnaire for Adults (Haem-A-QoL). The total score ranges from 0 to 100, with higher scores indicating poorer quality of life.

    Baseline

  • Joint Health

    Joint health will be evaluated using the Hemophilia Joint Health Score (HJHS). Higher scores indicate poorer joint health status.

    Baseline

  • Postural Balance

    Dynamic postural balance were evaluated with the Pro-kin Technobody Posturographic Platform (Pro-kin 212, Technobody s.r.l, Dalmine, 21044 Bergamo, Italy).

    Baseline

Secondary Outcomes (2)

  • Musculoskeletal Pain

    Baseline

  • Falls

    Baseline

Study Arms (1)

Hemophilia A

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with hemophilia A

You may qualify if:

  • Diagnosis of severe hemophilia A
  • Age ≥18 years
  • A minimum single-joint score of 3 points for the knee or ankle according to the Hemophilia Joint Health Score (HJHS)

You may not qualify if:

  • Use of walking aids (e.g., crutches)
  • Presence of neurological or psychiatric disorders, chronic inflammatory disease, -Regular use of medications that could affect balance,
  • History of major lower extremity surgery within the previous six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yil University

Van, 65080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemophilia AJoint DiseasesMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMusculoskeletal DiseasesMuscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ayse Merve Tat, Assistant Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start

February 21, 2026

Primary Completion

April 21, 2026

Study Completion (Estimated)

May 21, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations