Hemophilia A and BNCT07736976
Comparison of 30-Second Sit-to-Stand Test Performance Between Individuals With Hemophilia and Healthy Peers
An observational study of Hemophilia A and B, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Hemophilia is an inherited bleeding disorder characterized by recurrent musculoskeletal bleeding, particularly into joints, leading to impaired physical function and reduced functional performance. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia A and B
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 15 Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- Hemophilia Group:
- Acute joint bleeding episode within the previous 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir university
Istanbul, Istanbul, 34353
About this study
Official title: Comparison of 30-Second Sit-to-Stand Test Performance Between Individuals With Hemophilia and Healthy Peers: A Cross-Sectional Observational Study
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).
Read the 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
- Conditions
- Hemophilia A and B
- Keywords
- hemophilia A, hemophilia B, 30-Second Sit-to-Stand Test, Functional Performance, Hemophilic Arthropathy
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment (single assessment visit)
Secondary outcomes (2)
Joint Health Status Assessed by Hemophilia Joint Health Score (HJHS)
Joint health status will be assessed in participants with hemophilia using the Hemophilia Joint Health Score (HJHS). The HJHS evaluates hemophilic arthropathy-related findings including swelling, muscle atrophy, crepitus, range of motion loss, and pain in target joints. Total HJHS score ranges from 0 to 124; lower scores indicate better joint health and higher scores indicate greater joint impairment.
Measured: Baseline assessment (single assessment visit)
Hemophilia Activities List (HAL)
Functional activity level in participants with hemophilia will be assessed using the Hemophilia Activities List (HAL), a patient-reported outcome measure evaluating limitations in daily activities and participation. The total score ranges from 0 to 100, with higher scores indicating better functional ability and fewer activity limitations.
Measured: Baseline assessment (single assessment visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Aug 2026
- Primary completion15 Sep 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hemophilia A and BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Poyraz İşleyen, Bahçeşehir University
- Investigators
- Tığçe Poyraz İşleyen, Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736976
- Sponsor's protocol ID
- E-78097791-020-5767
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because there is no current plan to make individual-level data available to other researchers.
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.
PubMed 15357785Kuijlaars 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.
PubMed 33058441McKay 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.
PubMed 28330961Mannucci PM. Hemophilia therapy: the future has begun. Haematologica. 2020 Mar;105(3):545-553. doi: 10.3324/haematol.2019.232132. Epub 2020 Feb 14.
PubMed 32060150Stonebraker 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.
PubMed 21649801Mannucci 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.
PubMed 12871268Peyvandi 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.
PubMed 22726099
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 30-Second Sit-to-Stand Test Performance Between Individuals With Hemophilia and Healthy Peers: A Cross-Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07736976
- Acronym / sponsor ID
- E-78097791-020-5767
- Conditions
- Hemophilia A and B
- Keywords
- hemophilia A, hemophilia B, 30-Second Sit-to-Stand Test, Functional Performance, Hemophilic Arthropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (11 listed)
- Diagnosis of hemophilia A or hemophilia B
- Age between 18 and 35 years
- Ability to walk independently
- Willingness to participate in the study voluntarily
- Age between 18 and 35 years
Key exclusion criteria (2 listed)
- Acute joint bleeding episode within the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-Second Sit-to-Stand Test Performance
Time frame: Baseline assessment (single assessment visit)
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.
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 15357785van 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.
- Background: PubMed 33058441Kuijlaars 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.
- Background: PubMed 28330961McKay 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.
- Background: PubMed 32060150Mannucci PM. Hemophilia therapy: the future has begun. Haematologica. 2020 Mar;105(3):545-553. doi: 10.3324/haematol.2019.232132. Epub 2020 Feb 14.
- Background: PubMed 21649801Stonebraker 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.
- Background: PubMed 12871268Mannucci 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.
- Background: PubMed 22726099Peyvandi 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because there is no current plan to make individual-level data available to other researchers.
Related trials for Hemophilia A and B
RecruitingPhase 1/2
A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
Hemophilia A, Healthy Adult Participants
RecruitingPhase 3
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Haemophilia A
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia
RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
RecruitingObservational study
An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
Hemophilia A
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tığçe Poyraz İşleyen principal investigator
Bahçeşehir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A and B, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Second Sit-to-Stand Test Performance (time frame: Baseline assessment (single assessment visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07736976, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.