Cystic FibrosisNCT04673331
Comparison of Physical Activity, Exercise Capacity, Quality of Life, Cognitive Function and Coronavirus Phobia Levels of Adult Cystic Fibrosis Patients With Healthy Individuals With Telerehabilitation
An observational study of Cystic Fibrosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to evaluate physical activity, exercise capacity, quality of life, cognitive status level and coronavirus phobia level of adult cystic fibrosis patients and compare with the findings of healthy subjects with teleconference during COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- exercise capacity
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2021to 5 Aug 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and healthy individuals between 18-65 years old, who are diagnosed with cystic fibrosis will be included in the study.
Who may be able to join
- Being over 18 years old Having the ability to access the internet through a device (computer or mobile device) that enables video conferencing Giving consent on a voluntary basis
Who cannot join
- Severe comorbidity that limits mobilization or physical activity(orthopedic, cardiac or neurological condition) Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to evaluate physical activity, exercise capacity, quality of life, cognitive status level and coronavirus phobia level of adult cystic fibrosis patients and compare with the findings of healthy subjects with teleconference during COVID-19 pandemic.
Read the detailed description
This study will be participated adult with cystic fibrosis and healthy individuals. Demographic information of individuals will be recorded in online video conference. Physical activity, exercise capacity and cognitive function levels will be measured during video conferencing.Then, the physical activity level, coronavirus phobia and quality of life of the participants will be evaluated subjectively with questionnaires through the Google forms.
- Conditions
- Cystic Fibrosis
- Being tested
- exercise capacity
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise capacityOther
3minute step test and 1minute sit to stand test used assessment of exercise capacity.
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis | Inclusion Criteria:
Having been diagnosed with cystic fibrosis Being over 18 years old The clinical condition is stable Having the ability to access the internet through a device (computer or mobile device) that enables video conferencing Giving consent on a voluntary basis
Exclusion Criteria:
Severe comorbidity that limits mobilization or physical activity(orthopedic, cardiac or neurological condition) Pregnancy Receives: Other: exercise capacity | |
| Healthy individuals | Inclusion Criteria:
Being over 18 years old Having the ability to access the internet through a device (computer or mobile device) that enables video conferencing Giving consent on a voluntary basis
Exclusion Criteria:
Severe comorbidity that limits mobilization or physical activity(orthopedic, cardiac or neurological condition) Pregnancy Receives: Other: exercise capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level-International Physical Activity Questionnaire
Physical activity level will be evaluated International Physical Activity Questionnaire- Short Form (IPAQ-SF). IPAQ short version asks spended time during sitting, walking, moderate and vigorous physical activities. The score is obtained by multiplying the minutes, days and metabolic equivalent values. According to these scores, physical activity levels are classified as "inactive", "minimally active" and "very active".
Measured: 8 minutes
Coronavirus Phobia-Coronavirus-19 Phobia Scale
COVID-19 phobia will be evaluated with Coronavirus-19 Phobia Scale (C19P-S) and total score ranges from 20-100. Lower scores mean better outcome.
Measured: 5 minutes
Exercise Capacity
Exercise capacity will be evaluated with 1-minute sit to stand test and 3-minute step test. Maximum heart rate, minimum saturation, count of step are record during the 3 minute step test. Number of sit to stand for 1 minute is recorded end of the 1 minute sit to stand test.
Measured: 15 minutes
Weekly Average Steps
The number of steps in the last week was recorded and averaged using the pedometer applications from the participants own smartphones.
<5000 steps/day sedentary 5000-7499 steps/day low active 7500-9999 steps/day somewhat active
≥10 000 steps/day active >12 500 steps/day highly active
Measured: 2 minutes
Secondary outcomes (2)
Cognitive Function-Standardized Mini Mental State Examination
Cognitive function evaluation will be Standardized Mini Mental State Examination (SMMSE). Scores less than 23 mean cognitive impairment.
Measured: 5 minutes
Quality Of Life-Nottingham Health Profile
Quality of life will be evaluated with Nottingham Health Profile (NHP). This questionnaire categorizes are energy, pain, emotional reactions, sleep, social isolation, physical mobility, depression and anxiety. Lower scores mean better outcome.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start5 Jan 2021
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydan Aslı Aksel Uylar, Hacettepe University
- Investigators
- Naciye Vardar Yağlı, PhD, Study director, Hacettepe UniversityAydan Aslı Aksel, Principal investigator, Hacettepe UniversityEbru Damadoğlu, PhD, Study chair, Hacettepe UniversityMerve Fırat, MSc, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673331
- Sponsor's protocol ID
- GO 20/794
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2020
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physical Activity, Exercise Capacity, Quality of Life, Cognitive Function and Coronavirus Phobia Levels of Adult Cystic Fibrosis Patients With Healthy Individuals With Telerehabilitation
- ClinicalTrials.gov ID
- NCT04673331
- Acronym / sponsor ID
- GO 20/794
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 17 Dec 2020 (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.
The purpose of this study was to evaluate physical activity, exercise capacity, quality of life, cognitive status level and coronavirus phobia level of adult cystic fibrosis patients and compare with the findings of healthy subjects with teleconference during COVID-19 pandemic.
Detailed description
This study will be participated adult with cystic fibrosis and healthy individuals. Demographic information of individuals will be recorded in online video conference. Physical activity, exercise capacity and cognitive function levels will be measured during video conferencing.Then, the physical activity level, coronavirus phobia and quality of life of the participants will be evaluated subjectively with questionnaires through the Google forms.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis | – | Other: exercise capacityInclusion Criteria: Having been diagnosed with cystic fibrosis Being over 18 years old The clinical condition is stable Having the ability to access the internet through a device (computer or mobile device) that enables video conferencing Giving consent on a voluntary basis Exclusion Criteria: Severe comorbidity that limits mobilization or physical activity(orthopedic, cardiac or neurological condition) Pregnancy |
| Healthy individuals | – | Other: exercise capacityInclusion Criteria: Being over 18 years old Having the ability to access the internet through a device (computer or mobile device) that enables video conferencing Giving consent on a voluntary basis Exclusion Criteria: Severe comorbidity that limits mobilization or physical activity(orthopedic, cardiac or neurological condition) Pregnancy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and healthy individuals between 18-65 years old, who are diagnosed with cystic fibrosis will be included in the study.
Key inclusion criteria (1 listed)
- Being over 18 years old Having the ability to access the internet through a device (computer or mobile device) that enables video conferencing Giving consent on a voluntary basis
Key exclusion criteria (1 listed)
- Severe comorbidity that limits mobilization or physical activity(orthopedic, cardiac or neurological condition) Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise capacity3minute step test and 1minute sit to stand test used assessment of exercise capacity. | Other | Cystic fibrosis, Healthy individuals |
Primary outcome
Physical Activity Level-International Physical Activity Questionnaire
Time frame: 8 minutes
Physical activity level will be evaluated International Physical Activity Questionnaire- Short Form (IPAQ-SF). IPAQ short version asks spended time during sitting, walking, moderate and vigorous physical activities. The score is obtained by multiplying the minutes, days and metabolic equivalent values. According to these scores, physical activity levels are classified as "inactive", "minimally active" and "very active".
Coronavirus Phobia-Coronavirus-19 Phobia Scale
Time frame: 5 minutes
COVID-19 phobia will be evaluated with Coronavirus-19 Phobia Scale (C19P-S) and total score ranges from 20-100. Lower scores mean better outcome.
Exercise Capacity
Time frame: 15 minutes
Exercise capacity will be evaluated with 1-minute sit to stand test and 3-minute step test. Maximum heart rate, minimum saturation, count of step are record during the 3 minute step test. Number of sit to stand for 1 minute is recorded end of the 1 minute sit to stand test.
Weekly Average Steps
Time frame: 2 minutes
The number of steps in the last week was recorded and averaged using the pedometer applications from the participants own smartphones. <5000 steps/day sedentary 5000-7499 steps/day low active 7500-9999 steps/day somewhat active ≥10 000 steps/day active >12 500 steps/day highly active
2 secondary outcomes
Cognitive Function-Standardized Mini Mental State Examination
Time frame: 5 minutes
Quality Of Life-Nottingham Health Profile
Time frame: 10 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 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Naciye Vardar Yağlı, PhD study director
Hacettepe University
Aydan Aslı Aksel principal investigator
Hacettepe University
Ebru Damadoğlu, PhD study chair
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 1 inclusion and 1 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 31 Aug 2026. 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?
Physical Activity Level-International Physical Activity Questionnaire (time frame: 8 minutes). The study lists 4 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 31 Aug 2026.