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Cystic Fibrosis and Frailtyh What's in Common?

Cystic Fibrosis in Adults and Frailty

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06020547
Enrollment
139
Registered
2023-08-31
Start date
2022-05-01
Completion date
2023-08-01
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Frailty Syndrome

Keywords

functional status, frailty, Cystic Fibrosis, geriatric syndrome

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.

Interventions

None listed

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Pre-Frail/Frail Statusthrough study completion, an average of 1 yearFrailty has been assessed by the SOF Index

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026