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临床试验/NCT06554132
NCT06554132招募中不适用

Investigation of Respiratory Muscle Strength and Aerobic Capacity in Patients With Scleroderma

Firat University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
1
主要终点
Respiratory muscle strength assessment

研究概览

简要总结

Primary aim of this study was to compare respiratory muscle strength, aerobic capacity, dyspnea, pulmonary function tests and fatigue values with healthy controls. The secondary aim was to evaluate the relationship between respiratory muscle strength and other parameters in these patients and to examine the factors that may affect respiratory muscle strength. Respiratory muscle strength, aerobic capacity, respiratory function tests and fatigue will be evaluated

详细描述

Scleroderma is a systemic connective tissue disease characterized by progressive thickening of the skin, the etiology of which has not been fully elucidated, in which microvascular damage, immune activation and fibrosis play a role. Primary aim of this study was to compare respiratory muscle strength, aerobic capacity, dyspnea, pulmonary function tests and fatigue values with healthy controls. The secondary aim was to evaluate the relationship between respiratory muscle strength and other parameters in these patients and to examine the factors that may affect respiratory muscle strength. The study will include 15 patients and 15 healthy individuals of the same age and gender. Respiratory muscle strength, aerobic capacity, respiratory function tests and fatigue will be evaluated

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being diagnosed with Ssk according to ACR/EULAR criteria
  • Stable medical treatment for 3 months

排除标准

  • Having a regular exercise habit (doing regular exercise at least once a week for the last 3 months)
  • Comorbidity with another chronic disease that may affect aerobic capacity or respiratory muscle strength
  • Having concomitant acute respiratory diseases
  • Having a smoking habit
  • History of orthopedic or neurologic disease in the lower extremities that may prevent cycling

结局指标

主要结局

Respiratory muscle strength assessment

时间窗: 5 minutes

Respiratory muscle strength will be assessed with an intraoral pressure gauge. These are the intraoral pressures measured at maximal respiration against a valve that closes the airways. When applying MIP, the patient is asked to perform maximal expiration. As a result, the patient is asked to maximally inspire against the closed airway and maintain this for 1-3 seconds. MEP, on the other hand, after maximal inspiration, the patient is asked to perform maximal expiration against the closed airway for 1-3 seconds.

次要结局

  • Aerobic capacity assessment(10 minutes)
  • Fatigue assessment(2 minutes)
  • Pulmonary function test(5 minutes)

研究者

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

Songül Bağlan Yentür

Firat University

Firat University

研究点 (1)

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