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NCT06020547 Clinical Trial

Cystic Fibrosis and Frailtyh What's in Common?

Cystic Fibrosis Clinical Trial

Official title:
Cystic Fibrosis in Adults and Frailty

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06020547
Other study ID # CysFiFRa
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date August 1, 2023

Study information
Verified date August 2023
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 139
Est. completion date August 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Cystic Fibrosis for the Adults Centre Napoli

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pre-Frail/Frail Status Frailty has been assessed by the SOF Index through study completion, an average of 1 year
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