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临床试验/NCT06870890
NCT06870890尚未招募不适用

Impact of Sarcopenia on Dyspnea in Patients with Asthma

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Variation in the intensity of dyspnea during exercise mesured with Borg scale (0-10) according to the presence of sarcopenia

研究概览

简要总结

Dyspnea in asthma, is mainly due to airway obstruction but can be caused by several alternative diagnoses.

The impact of sarcopenia on dyspnea in patients with asthma is unknown. Sarcopenic asthma had a reduced physical activity and is associated with airway obstruction compared to non-sarcopenic asthma. In patients with obstructive pulmonary disease, sarcopenia is associated with shallow breathing and diverse sensory and affective components of exertional dyspnea .

The morbidity of sarcopenia is also increased by systemic inflammation and the production of inflammatory cytokines as found in inflammatory airway obstruction.

The investigators will investigate the prevalence and impact of sarcopenia in asthmatics patients. This will enable to better manage sarcopenia in asthmatic patients, understand its origins and personalize treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 18 years
  • •Patient affiliated to a social security scheme.
  • •Patient capable of giving free, informed, written and signed consent.
  • •Asthmatic patients with a diagnosis made by a pulmonologist on GINA level 4 or 5 treatment
  • •ACT asthma control score < 20
  • •Patient judged by the investigator to be able to to perform a maximal exercise test.

排除标准

  • •Patient under guardianship/trusteeship/supervision of justice
  • •Pregnant or breast-feeding women
  • •Unstable heart disease
  • •Patients who have been smoking or have stopped smoking for less than 5 years,

研究组 & 干预措施

All the patient included in the study

Experimental

干预措施: Cardiopulmonary exercise test (Diagnostic Test)

All the patient included in the study

Experimental

干预措施: muscle evaluation (Diagnostic Test)

All the patient included in the study

Experimental

干预措施: Dosage (Biological)

All the patient included in the study

Experimental

干预措施: Questionnaire and Physical Exam (Combination Product)

结局指标

主要结局

Variation in the intensity of dyspnea during exercise mesured with Borg scale (0-10) according to the presence of sarcopenia

时间窗: From baseline (at rest) to the end of the exercise

Recording of Borg's dyspnea score during exercise on a scale of 0 (no dyspnea) to 10 (major dyspnea)

次要结局

  • Variation in exercise-induced release of biomarkers according to the presence of sarcopenia(at rest = baseline / right after the end of exercice / 45 minutes after the end of exercice)
  • Difference in muscle mass (kg) on impedancemetry according to the presence of sarcopenia(Baseline)
  • Difference on maximum aerobic capacity (VO2 max in L/mn) , according to the presence of sarcopenia(immediately after the exercise test)
  • Difference in fat mass (kg) on impedancemetry according to the presence of sarcopenia(At baseline)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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