Assessment of Cognitive Function and Exercise Capacity in Cystic Fibrosis

NCT ID: NCT06175182

Last Updated: 2024-10-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-14

Study Completion Date

2023-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cystic fibrosis (CF) affects other body systems as well as the respiratory system. Patients with CF seem to have reduced exercise capacity, which is a major contributor to mortality rates. Changes in lung function, ventilatory dysfunction, and respiratory muscle function potentially contribute to exercise intolerance in CF. Both children and adults with CF exhibit neurocognitive dysfunction. Arterial stiffness is a predictor of cardiovascular events, including myocardial infarction, heart failure, and mortality. Individuals with CF exhibit an increase in arterial stiffness. However, no studies in the literature have investigated cognitive function, exercise capacity, and arterial stiffness coexistence in adult CF patients. The study aims to compare the cognitive function, exercise capacity, exercise muscle oxygenation and arterial stiffness in adult patients with CF and healthy subjects. Additionally, it will determine the relationship between cognitive function and arterial stiffness with exercise capacity and muscle oxygenation during exercise in adult patients with CF.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cystic fibrosis

No intervention

No interventions assigned to this group

healthy volunteers

No intervention

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Who did not volunteer to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Deniz Inal-Ince

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deniz Inal-Ince, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hacettepe University

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GO 22/917

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.