Assessment of Cognitive Function and Exercise Capacity in Cystic Fibrosis

NCT06175182 | Completed

• 1 other identifier: GO 22/917
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

No studies in the literature have investigated the simultaneous effects of cognitive function, exercise capacity and arterial stiffness in adult patients with CF. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation, and arterial stiffness of adult patients with CF and healthy subjects.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; exercise test; cognitive impairment; arterial stiffness

Outcome Measures

Primary Outcomes (5)

• Exercise capacity

  Exercise capacity is assessed using the 6-minute walk test (6MWT). The 6MWT is performed according to the criteria of the American Thoracic Society.

  6 minutes

• Arterial Stiffness Assessment

  Arterial stiffness is determined using a oscillometric cuff device (Tel-O-Graph BT, I.E.M., Stolberg, Germany). Pulse wave velocity (PWV) and augmentation index (AIx) are measured by brachial pulse waves.

  20 minutes

• Cognitive Assessment- MoCA

  Cognitive function is measured using the Montreal Cognitive Assessment (MoCA) test. The MoCA test is a questionnaire developed to evaluate different cognitive functions and mild cognitive impairment. The maximum score that an individual can obtain from the test is 30, and a score of 26 above is considered as mild cognitive impairment.

  10 minutes

• Cognitive Assessment-Mini Mental Test

  Cognitive function is measured using the Mini Mental Test. A higher score indicates better cognitive function. The maximum score that an individual can obtain from the test is 30, and a score of 23 and above is considered as cognitive impairment.

  10 minutes

• Muscle Oxygenation Assessment

  Muscle oxygenation (SmO2) is assessed using a measuring and monitoring device (Moxy Fortiori Desing LLC, Minnesota, USA).

  10 minutes

Secondary Outcomes (13)

• Body Composition

  5 minutes

• Pulmonary Function Test (forced vital capacity (FVC))

  10 minutes

• Pulmonary Function Test (forced expiratory volume in the first second (FEV1))

  10 minutes

• Pulmonary Function Test (FEV1/FVC)

  10 minutes

• Pulmonary Function Test (peak flow rate (PEF))

  10 minutes

Study Arms (2)

cystic fibrosis

No intervention

healthy volunteers

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

24 patients with cystic fibrosis will be included in patients group and 24 healthy individuals will be included in control group.

You may qualify if:

• Having been diagnosed with cystic fibrosis
• Being 18 years old and older
• Clinically stable condition
• Able to cooperate with the tests performed
• Volunteered to participate in the study
• For the control group:
• Being 18 years old and older
• Volunteered to participate in the study

You may not qualify if:

• History of hospitalization or exacerbation in the last month.
• Chronic respiratory failure and long-term use of oxygen therapy
• Using noninvasive mechanical ventilator therapy
• Indication for lung transplantation
• Who had a lung transplant
• Forced expiratory volume in the first second (FEV1) value 30% and below
• CF-related diabetes
• Chronic liver disease
• Allergic bronchopulmonary aspergillosis
• Systemic steroid use
• History of diagnosed orthopedic or musculoskeletal problems affecting mobility
• Cardiovascular instability
• Serious psychiatric illness
• For the control group:
• Known chronic or systemic disease

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06430, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Deniz Inal-Ince, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 18, 2023
• Study Start: December 14, 2022
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

TU (1)