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临床试验/NCT07152015
NCT07152015已完成不适用

Examination of Sarcopenia and Respiratory Functions in Multiple Sclerosis

Uskudar University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Forced Vital Capacity

研究概览

简要总结

The goal of this observational study is to evaluate the relationship between respiratory function and sarcopenia in people with multiple sclerosis.

The main questions it aims to answer are:

Is there a relationship between muscle structure and respiratory muscle strength/pulmonary function in MS patients?

Undergo a single session of respiratory muscle strength measurement (e.g., maximal inspiratory pressure [MIP], maximal expiratory pressure [MEP]) Perform spirometry to assess pulmonary function

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being diagnosed with MS by a neurologist
  • Being diagnosed with Sarcopenia
  • No history of attacks in the last 3 months
  • Able to walk with and without support (EDSS<6.5)

排除标准

  • Having concomitant lung and heart disease
  • Mini Mental score below 24
  • Being in pregnancy

结局指标

主要结局

Forced Vital Capacity

时间窗: 1 day (The evaluation will be done one-time)

FVC, defined as the total volume of air that can be forcibly exhaled after full inspiration, will be recorded with spirometry using the Cosmed Pony FX device, following ATS guidelines.

Forced Expiratory Volume in 1 second (FEV1)

时间窗: 1 day (The evaluation will be done one-time)

FEV1, spirometric evaluation of the maximum volume of air exhaled in the first second of a forced breath, will be measured using the Cosmed Pony FX device (Rome, Italy) in accordance with ATS standards.

FEV1/FVC Ratio (%)

时间窗: 1 day (The evaluation will be done one-time)

The ratio of FEV1 to FVC (FEV1/FVC) will be obtained as an index of airflow limitation. This ratio will be calculated from spirometry values measured with the Cosmed Pony FX device under ATS standards.

Maximal Inspiratory Pressure

时间窗: 1 day (The evaluation will be done one-time)

MIP, reflecting inspiratory muscle strength, will be assessed through maximal inspiratory efforts against a closed airway, using the Cosmed Pony FX device according to ATS recommendations.

Maximal Expiratory Pressure

时间窗: 1 day (The evaluation will be done one-time)

MEP, representing expiratory muscle strength, will be determined by maximal expiratory efforts against a closed airway. Measurements will be obtained with the Cosmed Pony FX device (Rome, Italy) according to ATS standards

次要结局

  • and grip strength measurement(1 day (The evaluation will be done one-time))
  • Skeletal Muscle Index (SMI, kg/m²)(1 day (The evaluation will be done one-time))

研究者

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

tuba kolaylı

Lecturer

Uskudar University

研究点 (1)

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