NCT07736976

Brief Summary

Hemophilia is an inherited bleeding disorder characterized by recurrent musculoskeletal bleeding, particularly into joints, leading to impaired physical function and reduced functional performance. The 30-Second Sit-to-Stand Test (30STS) is a simple, reliable, and valid measure of lower extremity functional performance; however, evidence regarding its performance in individuals with hemophilia remains limited. This cross-sectional observational study aims to compare 30STS performance between adults with hemophilia and age-matched healthy controls and to investigate the relationship between 30STS performance, joint health, and activity level in individuals with hemophilia. Fifty-eight participants (29 individuals with hemophilia and 29 healthy controls) aged 18-35 years will be recruited. Participants will complete the 30STS. Individuals with hemophilia will additionally undergo joint health assessment using the Hemophilia Joint Health Score (HJHS) and activity evaluation using the Hemophilia Activities List (HAL).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress1%
Aug 2026Sep 2026

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 27, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

hemophilia Ahemophilia B30-Second Sit-to-Stand TestFunctional PerformanceHemophilic Arthropathy

Outcome Measures

Primary Outcomes (1)

  • 30-Second Sit-to-Stand Test Performance

    The primary outcome of this study is the performance on the 30-Second Sit-to-Stand Test (30STS). The test evaluates lower extremity functional performance by recording the number of correctly completed sit-to-stand repetitions within 30 seconds. The test will be performed once under standardized conditions in both the hemophilia group and healthy control group. Number of complete sit-to-stand repetitions performed from a standard chair within 30 seconds. Scores range from 0 to no fixed maximum, with higher scores indicating better lower extremity functional performance and muscle endurance.

    Baseline assessment (single assessment visit)

Secondary Outcomes (2)

  • Joint Health Status Assessed by Hemophilia Joint Health Score (HJHS)

    Baseline assessment (single assessment visit)

  • Hemophilia Activities List (HAL)

    Baseline assessment (single assessment visit)

Study Arms (2)

Hemophilia Group

Participants aged 18-35 years with a diagnosis of hemophilia A or hemophilia B.

Healthy Control Group

Age-matched healthy participants without hemophilia or other bleeding disorders.

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study will include adult males aged 18-35 years with a diagnosis of hemophilia A or hemophilia B and age-matched healthy male controls. Participants with hemophilia will be recruited from the members of the Turkish Hemophilia Society. Healthy controls without hemophilia or other bleeding disorders will be recruited from the general population. A total of 58 participants, including 29 individuals with hemophilia and 29 healthy controls, are planned to be included in the study.

You may qualify if:

  • Hemophilia Group:
  • Diagnosis of hemophilia A or hemophilia B
  • Age between 18 and 35 years
  • Ability to walk independently
  • Willingness to participate in the study voluntarily
  • Healthy Control Group:
  • Age between 18 and 35 years
  • No history of hemophilia or other bleeding disorders
  • No history of lower extremity surgery or serious lower extremity injury within the previous 6 months
  • No neurological, rheumatological, or severe orthopedic disorders
  • Willingness to participate in the study voluntarily

You may not qualify if:

  • Hemophilia Group:
  • \- Acute joint bleeding episode within the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir university

Istanbul, Istanbul, 34353, Turkey (Türkiye)

Location

Related Publications (7)

  • van Genderen FR, van Meeteren NL, van der Bom JG, Heijnen L, de Kleijn P, van den Berg HM, Helders PJ. Functional consequences of haemophilia in adults: the development of the Haemophilia Activities List. Haemophilia. 2004 Sep;10(5):565-71. doi: 10.1111/j.1365-2516.2004.01016.x.

    PMID: 15357785BACKGROUND
  • Kuijlaars IAR, van der Net J, Feldman BM, Aspdahl M, Bladen M, de Boer W, Cuesta-Barriuso R, Matlary RED, Funk SM, Hilliard P, John JA, Kempton CL, de Kleijn P, Manco-Johnson M, Petrini P, Poonnoose P, St-Louis J, Thomas S, Timmer MA, Trakymiene SS, van Vlimmeren L, Fischer K. Evaluating international Haemophilia Joint Health Score (HJHS) results combined with expert opinion: Options for a shorter HJHS. Haemophilia. 2020 Nov;26(6):1072-1080. doi: 10.1111/hae.14180. Epub 2020 Oct 15.

    PMID: 33058441BACKGROUND
  • McKay MJ, Baldwin JN, Ferreira P, Simic M, Vanicek N, Burns J; 1000 Norms Project Consortium. Reference values for developing responsive functional outcome measures across the lifespan. Neurology. 2017 Apr 18;88(16):1512-1519. doi: 10.1212/WNL.0000000000003847. Epub 2017 Mar 22.

    PMID: 28330961BACKGROUND
  • Mannucci PM. Hemophilia therapy: the future has begun. Haematologica. 2020 Mar;105(3):545-553. doi: 10.3324/haematol.2019.232132. Epub 2020 Feb 14.

    PMID: 32060150BACKGROUND
  • Stonebraker JS, Bolton-Maggs PH, Michael Soucie J, Walker I, Brooker M. A study of variations in the reported haemophilia B prevalence around the world. Haemophilia. 2012 May;18(3):e91-4. doi: 10.1111/j.1365-2516.2011.02588.x. Epub 2011 Jun 7.

    PMID: 21649801BACKGROUND
  • Mannucci PM. Hemophilia: treatment options in the twenty-first century. J Thromb Haemost. 2003 Jul;1(7):1349-55. doi: 10.1046/j.1538-7836.2003.00262.x.

    PMID: 12871268BACKGROUND
  • Peyvandi F, Bolton-Maggs PH, Batorova A, De Moerloose P. Rare bleeding disorders. Haemophilia. 2012 Jul;18 Suppl 4:148-53. doi: 10.1111/j.1365-2516.2012.02841.x.

    PMID: 22726099BACKGROUND

MeSH Terms

Conditions

Hemophilia AHemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Officials

  • Tığçe Poyraz İşleyen

    Bahçeşehir University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuğçe Poyraz İşleyen

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because there is no current plan to make individual-level data available to other researchers.

Locations