此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Investigation of the Prevalence of Sarcopenia and Dynapenia According to Disease Stage in Patients With Multiple Sclerosis and Evaluation of the Relationship Between Sarcopenia Severity and Clinical and Functional Parameters (MS-Sarcopenia)

2026年9月21日 更新者:Süleyman Korkusuz、Atılım University

This cross-sectional observational study aims to determine the prevalence of sarcopenia and dynapenia across disability stages in patients with multiple sclerosis (MS) and investigate their associations with clinical and functional parameters. Approximately 150 patients will be classified into two groups according to their Expanded Disability Status Scale (EDSS) scores: mild disability (EDSS < 4.0) and moderate disability (EDSS 4.0-6.5). Sarcopenia and dynapenia will be assessed using the ISarcoPRM algorithm. Physical activity, fatigue, and functional independence will also be evaluated.

研究概览

地位

尚未招聘

详细说明

Participants will undergo assessments of handgrip strength, five-times sit-to-stand performance, and ultrasound-based muscle mass using the Sonographic Thigh Adjustment Ratio (STAR). Sarcopenia and dynapenia will be classified according to the ISarcoPRM algorithm. Additional assessments will include the SARC-F questionnaire, smartwatch-derived physical activity, Modified Fatigue Impact Scale (MFIS), Functional Independence Measure (FIM), and Barthel Index. The prevalence of sarcopenia and dynapenia will be compared between disability groups, and associations with clinical and functional parameters will be examined.

研究类型

观察性的

注册 (估计的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Approximately 150 adults diagnosed with multiple sclerosis (MS) receiving care at the Physiotherapy and Rehabilitation Unit of Başkent University Hospital. Participants will be classified into mild (EDSS <4.0) and moderate (EDSS 4.0-6.5) disability groups.

描述

Inclusion Criteria:

  • Aged 18 years or older.
  • Diagnosed with multiple sclerosis (MS) by a neurologist.
  • Standardized Mini-Mental State Examination (SMMSE) score ≥24.
  • Expanded Disability Status Scale (EDSS) score ≤6.5.
  • Willing to participate and provide written informed consent.

Exclusion Criteria:

  • Orthopedic surgery within the previous 3 months.
  • Botulinum toxin injection within the previous 3 months.
  • Severe cognitive impairment affecting the ability to complete assessments.
  • Severe cardiopulmonary disease.
  • Serious orthopedic or additional neurological conditions that may affect the assessments.
  • Severe pain (Visual Analog Scale [VAS] score >7).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:CROSS_SECTIONAL

队列和干预

团体/队列
Mild Disability MS

Patients with multiple sclerosis with an Expanded Disability Status Scale (EDSS) score below 4.0.

Moderate Disability MS

Patients with multiple sclerosis with an Expanded Disability Status Scale (EDSS) score between 4.0 and 6.5.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Prevalence of Sarcopenia
大体时间:Baseline

Sarcopenia will be classified using the ISarcoPRM algorithm based on low muscle mass (STAR) combined with reduced handgrip strength and/or physical performance. Prevalence will be calculated as the percentage of participants meeting the criteria in each EDSS group.

Baseline
Prevalence of Dynapenia
大体时间:Baseline

Dynapenia will be defined as reduced muscle strength, independently of muscle mass, based on low handgrip strength (<32 kg for men; <19 kg for women) and/or prolonged five-times sit-to-stand time (≥12 seconds). Prevalence will be calculated as the percentage of participants meeting the criteria in each EDSS group.

Baseline

次要结果测量

结果测量
措施说明
大体时间
Handgrip Strength
大体时间:Baseline

Handgrip strength will be measured using a calibrated hand dynamometer. The highest value from at least two trials will be recorded in kilograms (kg).

Baseline
Five-Times Sit-to-Stand Test
大体时间:Baseline

Participants will be asked to stand up and sit down five times without using their arms. Completion time will be recorded in seconds. A duration of 12 seconds or longer will indicate reduced physical performance.

Baseline
Sonographic Thigh Adjustment Ratio (STAR)
大体时间:Baseline

Anterior thigh muscle thickness will be assessed using ultrasonography and adjusted for body mass index to calculate STAR. Low muscle mass will be defined as STAR <1.0 in women and <1.4 in men.

Baseline
Sarcopenia Risk (SARC-F)
大体时间:Baseline

Sarcopenia risk will be assessed using the five-item SARC-F questionnaire. Total scores range from 0 to 10, with higher scores indicating greater risk. A score of 4 or higher indicates sarcopenia risk.

Baseline
Modified Fatigue Impact Scale (MFIS)
大体时间:Baseline

Fatigue will be assessed using the 21-item MFIS. Total scores range from 0 to 84, with higher scores indicating a greater impact of fatigue on daily functioning.

Baseline
Functional Independence Measure (FIM)
大体时间:Baseline

Functional independence will be assessed using the 18-item FIM. Total scores range from 18 to 126, with higher scores indicating greater independence in daily activities.

Baseline
Barthel Index
大体时间:Baseline

Independence in activities of daily living will be assessed using the Barthel Index. Total scores range from 0 to 100, with higher scores indicating greater functional independence.

Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Ayşenur Özcan、Çankırı Karatekin University
  • 首席研究员:Büşra Seçkinoğulları Korkusuz, PhD、Ankara University
  • 学习椅:Süleyman Korkusuz、Atılım University
  • 学习椅:Ali M Özcan、Baskent University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月10日

初级完成 (估计的)

2026年12月10日

研究完成 (估计的)

2026年12月20日

研究注册日期

首次提交

2026年9月21日

首先提交符合 QC 标准的

2026年9月21日

首次发布 (实际的)

2026年9月25日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅