Cystic Fibrosis and Frailtyh What's in Common?

Federico II University

Status: Completed

Conditions: Frailty Syndrome; Cystic Fibrosis

Study type: Observational

Funder types: Other

Identifiers

NCT06020547

CysFiFRa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

139 participants in 1 patient group

Adults with Cystic Fibrosis

Description:

All patients who met the diagnostic criteria for CF, over 18 years old, with pathological sweat chloride levels (chloride \>60 mEq/L) and two CFTR mutations were recruited. Sweat chloride levels have been tested, and a panel of CFTR mutations screened. The CFTR genotype has been defined through the screening of the most frequent mutations and rearrangements.