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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Prevalence of Sarcopenia
研究概览
简要总结
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.
详细描述
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Diagnosed with multiple sclerosis (MS) by a neurologist.
- •Standardized Mini-Mental State Examination (SMMSE) score ≥
- •Expanded Disability Status Scale (EDSS) score ≤6.
- •Willing to participate and provide written informed consent.
排除标准
- •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).
研究组 & 干预措施
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.
结局指标
主要结局
Prevalence of Sarcopenia
时间窗: 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.
Prevalence of Dynapenia
时间窗: 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.
次要结局
- Handgrip Strength(Baseline)
- Five-Times Sit-to-Stand Test(Baseline)
- Sonographic Thigh Adjustment Ratio (STAR)(Baseline)
- Sarcopenia Risk (SARC-F)(Baseline)
- Modified Fatigue Impact Scale (MFIS)(Baseline)
- Functional Independence Measure (FIM)(Baseline)
- Barthel Index(Baseline)
研究者
Süleyman Korkusuz
Assist. Prof. Dr
Atılım University