Cystic Fibrosis and Frailtyh What's in Common?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-08-01

Brief Summary

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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

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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

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Frailty Syndrome Cystic Fibrosis

Keywords

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functional status frailty Cystic Fibrosis geriatric syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Adults with Cystic Fibrosis

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.

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Graziamaria Corbi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Graziamaria Corbi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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Cystic Fibrosis for the Adults Centre

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CysFiFRa

Identifier Type: -

Identifier Source: org_study_id