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临床试验/NCT07736976
NCT07736976尚未招募不适用

Comparison of 30-Second Sit-to-Stand Test Performance Between Individuals With Hemophilia and Healthy Peers: A Cross-Sectional Observational Study

Bahçeşehir University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
58
试验地点
1
主要终点
30-Second Sit-to-Stand Test Performance

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

结局指标

主要结局

30-Second Sit-to-Stand Test Performance

时间窗: 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.

次要结局

  • Joint Health Status Assessed by Hemophilia Joint Health Score (HJHS)(Baseline assessment (single assessment visit))
  • Hemophilia Activities List (HAL)(Baseline assessment (single assessment visit))

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuğçe Poyraz İşleyen

Principle investigator

Bahçeşehir University

研究点 (1)

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