Comparison of 30-Second Sit-to-Stand Test Performance Between Individuals With Hemophilia and Healthy Peers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hemophilia A and B. Basic parameters: 18 years — 35 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of 30-Second Sit-to-Stand Test Performance Between Individuals With Hemophilia and Healthy Peers: A Cross-Sectional Observational Study
Overview
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).
Detailed description
Hemophilia is an inherited bleeding disorder caused by deficiency of coagulation factor VIII (hemophilia A) or factor IX (hemophilia B), resulting in recurrent bleeding episodes. Repeated musculoskeletal bleeding, particularly hemarthrosis, may lead to progressive joint damage, reduced physical activity, muscle weakness, and impaired functional performance. Therefore, objective assessment of physical function is important for monitoring functional limitations and planning appropriate rehabilitation strategies in individuals with hemophilia.
The 30-Second Sit-to-Stand Test (30STS) is a simple, practical, and reliable performance-based assessment used to evaluate lower extremity strength, endurance, and functional mobility. Although the test is widely used in different populations, evidence regarding 30STS performance in individuals with hemophilia is limited. Comparing functional performance between individuals with hemophilia and healthy peers may provide valuable information regarding the functional impact of hemophilia and may contribute to clinical assessment approaches.
The aim of this cross-sectional observational study is to compare 30STS performance between individuals with hemophilia and age-matched healthy controls. Additionally, the study aims to investigate the relationship between 30STS performance, joint health status, and activity level in individuals with hemophilia.
A total of 58 participants aged 18-35 years will be included in the study, consisting of 29 individuals diagnosed with hemophilia A or hemophilia B and 29 age-matched healthy controls. All participants will perform the 30STS. Demographic characteristics, including age, height, and body weight, will be recorded. For participants with hemophilia, additional clinical information including hemophilia type, disease severity, bleeding history, and prophylaxis status will be collected.
Joint health status of individuals with hemophilia will be evaluated using the Hemophilia Joint Health Score (HJHS), and functional activity level will be assessed using the Hemophilia Activities List (HAL). The results of the 30STS will be compared between groups, and associations between functional performance, joint health, and activity level will be analyzed within the hemophilia group.
The findings of this study may contribute to a better understanding of lower extremity functional performance in individuals with hemophilia and may provide clinically relevant information for functional evaluation and rehabilitation planning
Primary outcome measures
- 30-Second Sit-to-Stand Test Performance [Time frame: Baseline assessment (single assessment visit)]
Secondary outcome measures (2)
- Joint Health Status Assessed by Hemophilia Joint Health Score (HJHS) [Time frame: Baseline assessment (single assessment visit)]
- Hemophilia Activities List (HAL) [Time frame: Baseline assessment (single assessment visit)]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
Hemophilia Group:
\- Acute joint bleeding episode within the previous 3 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Bahcesehir university — Istanbul
Publications
- 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 15357785
- 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 PMID 33058441
- 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 28330961
- 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 32060150
- 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 21649801
- 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 12871268
- 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 22726099
Identifiers
NCT: NCT07736976 · E-78097791-020-5767