Cystic Fibrosis in Adults and Frailty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Pre-Frail/Frail Status
研究概览
简要总结
The goal of this observational study is to assess the main clinical and anamnestic characteristics, and frailty syndrome in an adult Cystic Fibrosis population. The main question it aims to answer is the possible association of the frailty status with the main clinical, therapeutical characteristics, including the genotyping classification of Cystic Fibrosis patients.
详细描述
Participants will be assessed for the pulmonary status by spirometry (for Forced Expiratory Volume in 1 second [FEV1 - L]; Forced Expiratory Volume in 1 second percent predicted [ppFEV1%]; Forced Vital Capacity [FVC - L]; Forced Vital Capacity percent predicted [FVC %]; Maximal Mid-Expiratory Flow [MMEF]); for the functional status by evaluating the activities of daily living [ADLs], and the instrumental ADLs [IADLs]; and for frailty by the Study of Osteoporotic Fractures [SOF] Index. The height and weight will be also recorded, and Body Mass Index [BMI] calculated as body weight divided by height squared [Kg/m2]. Body weight will be measured in a fasting state in the morning with a mechanical balance.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who met the diagnostic criteria for CF,
- •over 18 years old,
- •pathological sweat chloride levels (chloride >60 mEq/L) and two CFTR mutations
排除标准
- •who did not meet the diagnostic criteria for CF
- •under 18 years old
- •over 18 years old with normal sweat chloride levels (chloride >60 mEq/L)
结局指标
主要结局
Pre-Frail/Frail Status
时间窗: through study completion, an average of 1 year
Frailty has been assessed by the SOF Index
次要结局
未报告次要终点
研究者
Graziamaria Corbi
Associate Professor
Federico II University