Cystic Fibrosis and Frailtyh What's in Common?

Completed

• Conditions: Cystic Fibrosis; Frailty Syndrome

• Registration Number: NCT06020547
• Lead Sponsor: Federico II University

Brief 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.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2023-06-01
• Status Verified: 2023-08
• Study Completion: 2023-08-01
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Study First Posted: 2023-08-31
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• who met the diagnostic criteria for CF,
• over 18 years old,
• pathological sweat chloride levels (chloride >60 mEq/L) and two CFTR mutations

Exclusion Criteria

• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pre-Frail/Frail Status	through study completion, an average of 1 year	Frailty has been assessed by the SOF Index

Trial Locations

Locations (1)

Cystic Fibrosis for the Adults Centre; 🇮🇹 Napoli, Italy