Cystic FibrosisNCT06175182
Assessment of Cognitive Function and Exercise Capacity in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Dec 2022to 14 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 24 patients with cystic fibrosis will be included in patients group and 24 healthy individuals will be included in control group.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, exercise test, cognitive impairment, arterial stiffness
- Medical subject headings
- Cystic Fibrosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cystic fibrosis | No intervention | |
| healthy volunteers | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 minutes
Muscle Oxygenation Assessment
Muscle oxygenation (SmO2) is assessed using a measuring and monitoring device (Moxy Fortiori Desing LLC, Minnesota, USA).
Measured: 10 minutes
Secondary outcomes (13)
Body Composition
Body fat is measured using skinfold thickness assessment.
Measured: 5 minutes
Pulmonary Function Test (forced vital capacity (FVC))
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).
Measured: 10 minutes
Pulmonary Function Test (forced expiratory volume in the first second (FEV1))
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).
Measured: 10 minutes
Pulmonary Function Test (FEV1/FVC)
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.
Measured: 10 minutes
Pulmonary Function Test (peak flow rate (PEF))
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).
Measured: 10 minutes
Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))
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%).
Measured: 10 minutes
Respiratory Muscle Strength
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) are measured using a mouth pressure measuring device with personal antibacterial and antiviral disposable filters.
Measured: 10 minutes
Peripheral Muscle Strength
Knee extensor muscle strength is measured utilizing a portable device.
Measured: 5 minutes
Anxiety and Depression
The Hospital Anxiety and Depression scale (HADS) is used to evaluate anxiety and depression. Higher scores correspond to more anxiety and depression symptoms.
Measured: 5 minutes
Physical Activity Assessment
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.
Measured: 5 minutes
Sleep Quality
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.
Measured: 5 minutes
Disease Specific Quality of Life
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.
Measured: 8 minutes
General Health-Related Quality of Life
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start14 Dec 2022
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Inal-Ince, Hacettepe University
- Investigators
- Deniz Inal-Ince, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175182
- Sponsor's protocol ID
- GO 22/917
- Status last verified
- Oct 2024
- First submitted
- 30 Nov 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Exercise Capacity, Arterial Stiffness, and Cognitive Function Between Adults With Cystic Fibrosis and Healthy Individuals
- ClinicalTrials.gov ID
- NCT06175182
- Acronym / sponsor ID
- GO 22/917
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, exercise test, cognitive impairment, arterial stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cystic fibrosis | – | –No intervention |
| healthy volunteers | – | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 24 patients with cystic fibrosis will be included in patients group and 24 healthy individuals will be included in control group.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Arterial Stiffness Assessment
Time frame: 20 minutes
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.
Cognitive Assessment- MoCA
Time frame: 10 minutes
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.
Cognitive Assessment-Mini Mental Test
Time frame: 10 minutes
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.
Muscle Oxygenation Assessment
Time frame: 10 minutes
Muscle oxygenation (SmO2) is assessed using a measuring and monitoring device (Moxy Fortiori Desing LLC, Minnesota, USA).
13 secondary outcomes
Body Composition
Time frame: 5 minutes
Pulmonary Function Test (forced vital capacity (FVC))
Time frame: 10 minutes
Pulmonary Function Test (forced expiratory volume in the first second (FEV1))
Time frame: 10 minutes
Pulmonary Function Test (FEV1/FVC)
Time frame: 10 minutes
Pulmonary Function Test (peak flow rate (PEF))
Time frame: 10 minutes
Pulmonary Function Test (forced expiratory flow from 25-75% (FEF25-75%))
Time frame: 10 minutes
Respiratory Muscle Strength
Time frame: 10 minutes
Peripheral Muscle Strength
Time frame: 5 minutes
Anxiety and Depression
Time frame: 5 minutes
Physical Activity Assessment
Time frame: 5 minutes
Sleep Quality
Time frame: 5 minutes
Disease Specific Quality of Life
Time frame: 8 minutes
General Health-Related Quality of Life
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deniz Inal-Ince, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: 6 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.