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Cystic Fibrosis and Frailtyh What's in Common?

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ClinicalTrials.gov Identifier: NCT06020547
Recruitment Status : Completed
First Posted : August 31, 2023
Last Update Posted : August 31, 2023
Sponsor:
Information provided by (Responsible Party):
Graziamaria Corbi, Federico II University

Study Description
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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.

Condition or disease
Frailty Syndrome Cystic Fibrosis

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 Design
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Study Type : Observational
Actual Enrollment : 139 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cystic Fibrosis in Adults and Frailty
Actual Study Start Date : May 1, 2022
Actual Primary Completion Date : June 1, 2023
Actual Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Pre-Frail/Frail Status [ Time Frame: through study completion, an average of 1 year ]
    Frailty has been assessed by the SOF Index


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of 139 CF patients referred to the Cystic Fibrosis for the Adults Centre of the University Federico II of Naples.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020547


Locations
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Italy
Cystic Fibrosis for the Adults Centre
Napoli, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Graziamaria Corbi, MD, PhD Federico II University
More Information
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Responsible Party: Graziamaria Corbi, Associate Professor, Federico II University
ClinicalTrials.gov Identifier: NCT06020547    
Other Study ID Numbers: CysFiFRa
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: the data will be treated as pooled

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Graziamaria Corbi, Federico II University:
functional status
frailty
Cystic Fibrosis
geriatric syndrome
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Frailty
Pathologic Processes
Pancreatic Diseases
 Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases