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NCT Number: NCT06020547

Cystic Fibrosis and Frailtyh What's in Common?

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.

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Key information

Conditions

Frailty Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Frailty Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cystic Fibrosis for the Adults Centre

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Pre-Frail/Frail Status

    Time frame: through study completion, an average of 1 year

    Frailty has been assessed by the SOF Index

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Cystic Fibrosis in Adults and Frailty

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2023
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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