- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06175182
Assessment of Cognitive Function and Exercise Capacity in Cystic Fibrosis
December 8, 2023 updated by: Deniz Inal-Ince, Hacettepe University
A Comparison of Exercise Capacity, Arterial Stiffness, and Cognitive Function Between Adults With Cystic Fibrosis and Healthy Individuals
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zeynep Soyoglu, M.Sc
- Phone Number: 178 +90-312-305 2525
- Email: zzeynep.soyoglu@gmail.com
Study Locations
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Ankara, Turkey, 06430
- Recruiting
- HACETTEPE UNIVERSİTY
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Contact:
- Zeynep Soyoglu, M.Sc
- Phone Number: +903123052525
- Email: zzeynep.soyoglu@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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cystic fibrosis
No intervention
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healthy volunteers
No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise capacity
Time Frame: 6 minutes
|
Exercise capacity is assessed using the 6-minute walk test (6MWT).
The 6MWT is performed according to the criteria of the American Thoracic Society.
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6 minutes
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Arterial Stiffness Assessment
Time Frame: 20 minutes
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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.
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20 minutes
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Cognitive Assessment- MoCA
Time Frame: 10 minutes
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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.
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10 minutes
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Cognitive Assessment-Mini Mental Test
Time Frame: 10 minutes
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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.
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10 minutes
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Muscle Oxygenation Assessment
Time Frame: 10 minutes
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Muscle oxygenation (SmO2) is assessed using a measuring and monitoring device (Moxy Fortiori Desing LLC, Minnesota, USA).
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10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Composition
Time Frame: 5 minutes
|
Body fat is measured using skinfold thickness assessment.
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5 minutes
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Pulmonary Function Test (forced vital capacity (FVC))
Time Frame: 10 minutes
|
Testing procedures is in accordance with the guidelines published by ATS/ERS.
A portable spirometer is used for assessment.
Pulmonary function testing assesses forced vital capacity (FVC).
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10 minutes
|
Pulmonary Function Test (forced expiratory volume in the first second (FEV1))
Time Frame: 10 minutes
|
Testing procedures is in accordance with the guidelines published by ATS/ERS.
A portable spirometer is used for assessment.
Pulmonary function testing assesses forced expiratory volume in the first second (FEV1).
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10 minutes
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Pulmonary Function Test (FEV1/FVC)
Time Frame: 10 minutes
|
Testing procedures is in accordance with the guidelines published by ATS/ERS.
A portable spirometer is used for assessment.
Pulmonary function testing assesses FEV1/FVC.
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10 minutes
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Pulmonary Function Test (peak flow rate (PEF))
Time Frame: 10 minutes
|
Testing procedures is in accordance with the guidelines published by ATS/ERS.
A portable spirometer is used for assessment.
Pulmonary function testing assesses peak flow rate (PEF).
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10 minutes
|
Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))
Time Frame: 10 minutes
|
Testing procedures is in accordance with the guidelines published by ATS/ERS.
A portable spirometer is used for assessment.
Pulmonary function testing assesses forced expiratory flow from 25-75% (FEF25-75%).
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10 minutes
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Respiratory Muscle Strength
Time Frame: 10 minutes
|
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) are measured using a mouth pressure measuring device with personal antibacterial and antiviral disposable filters.
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10 minutes
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Peripheral Muscle Strength
Time Frame: 5 minutes
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Knee extensor muscle strength is measured utilizing a portable device.
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5 minutes
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Anxiety and Depression
Time Frame: 5 minutes
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The Hospital Anxiety and Depression scale (HADS) is used to evaluate anxiety and depression.
Higher scores correspond to more anxiety and depression symptoms.
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5 minutes
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Physical Activity Assessment
Time Frame: 5 minutes
|
Physical activity levels is assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
The IPAQ requires respondents to estimate time spent in various levels of physical activity during the previous week.
Scores for walking and moderate and vigorous activities are calculated as durations and frequencies multiplied by known metabolic equivalents per activity.
The results for all activity-based items are summed for the total physical activity score.
The participants were then categorized as inactive, minimally active and sufficiently active according to the IPAQ categorical classification.
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5 minutes
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Sleep Quality
Time Frame: 5 minutes
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Sleep quality is evaluated using the Pittsburgh Sleep Quality Index (PSQI).
The scale total score is between 0 and 21.
A total score of 5 and above indicates poor sleep quality.
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5 minutes
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Disease Specific Quality of Life
Time Frame: 8 minutes
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Disease-specific quality of life is evaluated using the Cystic Fibrosis Questionnaire-Revised (CFQ-R).
The CFQ-R includes 50 items across 12 domains.
Each domain is standardized on a 0-100 scale; higher scores indicate better quality of life.
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8 minutes
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General Health-Related Quality of Life
Time Frame: 5 minutes
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Health-related quality of life is assessed using the Nottingham Health Profile (NHP).
It is a general QOL questionnaire designed to measure perceived health problems and the extent to which these problems affect normal daily activities.
It consists of 38 items in six dimensions (energy level, pain, physical mobility, emotional reactions, social isolation, and sleep).
The total score for each section is 0-100.
High scores indicate worse quality of life.
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5 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Deniz Inal-Ince, PhD, HACETTEPE UNIVERSİTY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2022
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
November 30, 2023
First Submitted That Met QC Criteria
December 8, 2023
First Posted (Estimated)
December 18, 2023
Study Record Updates
Last Update Posted (Estimated)
December 18, 2023
Last Update Submitted That Met QC Criteria
December 8, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 22/917
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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