NCT06020547

Cystic Fibrosis and Frailtyh What's in Common?

Cystic Fibrosis in Adults and Frailty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 139 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Frailty Syndrome
• Cystic Fibrosis

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-06-01
• Completion: 2023-08-01
• First posted: 2023-08-31
• Last updated: 2023-08-31

Locations

1 site across 1 country: Italy