Primary Ciliary DyskinesiaNCT05712798
Physiological Responses to Exercise Tests in Primary Ciliary Dyskinesia Compared With Healthy Individuals
An observational study of Primary Ciliary Dyskinesia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The individuals with primary ciliary dyskinesia (PCD) have lower aerobic fitness and anaerobic performance than healthy individuals. Cardiopulmonary exercise test (CPET) provides an integrated assessment of integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Ciliary Dyskinesia
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2020to 7 Oct 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The children with primary ciliary dyskinesia and healthy children
Who may be able to join
- Having been diagnosed with PCD in the Pediatrics Department, Pediatric Chest Diseases Unit of Hacettepe University Faculty of Medicine and being routinely referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit for physiotherapy applications and pulmonary rehabilitation program,
- Being clinically stable,
- Being between 8-18 years old,
- Having a forced expiratory volume in the first second (FEV1) ≥ 40%,
- The healthy group will be composed of individuals who do not have any known disease and volunteer to participate in the study. For healthy individuals, volunteers from acquaintances and/or relatives of the researchers will be included in the study.
Who cannot join
- Having unstable clinical condition
- Having severe neuromuscular and musculoskeletal problems,
- Having any congenital heart diseases other than situs inversus,
- Unable to cooperate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
Official title: Physiological Responses to Exercise Tests in Primary Ciliary Dyskinesia Compared With Healthy Children and Investigation of the Relationship Between Exercise Capacity and Quality of Life in Primary Ciliary Dyskinesia
The individuals with primary ciliary dyskinesia (PCD) have lower aerobic fitness and anaerobic performance than healthy individuals. Cardiopulmonary exercise test (CPET) provides an integrated assessment of integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems that are not adequately reflected by measurement of the function of organ systems. Maximum oxygen consumption is measured by performing gas exchange analysis with CPET, offering an objective measure of cardiorespiratory fitness. The six-minute walk test (6MWT) and the shuttle walk test (SWT) are field tests that produce oxygen consumption results similar to those during CPET. There is a need to determine the physiological responses to CPET, SWT and 6MWT in individuals with PCD. Additionally, the physiological responses of individuals with PCD to different exercise tests will be compared with the responses of healthy individuals. Low aerobic capacity in individuals with PCD may affect the physical, emotional, and social lives of individuals. This influence may cause a decrease in the quality of life of individuals with PCD. The relationship between exercise capacity and quality of life in individuals with PSD will be investigated with this study.
- Conditions
- Primary Ciliary Dyskinesia
- Being tested
- No intervention
- Medical subject headings
- Ciliary Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| The children with primary ciliary dyskinesia | The children with primary ciliary dyskinesia Receives: Other: No intervention | |
| Healthy controls | Healthy children Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shuttle walk test distance
Shuttle walk test distance will be determined using shuttle walk test
Measured: up to 3 weeks
Quality of life score
Quality of life score will be determined using multidimensional measure to assess health-related quality of life in primary ciliary dyskinesia (QoL-PCD).
Measured: 1st day
Maximal oxygen uptake
Maximal oxygen uptake will be determined using cardiopulmonary exercise test.
Measured: up to 3 weeks
6 minute walk test distance
6 minute walk test distance will be determined using 6 minute walk test
Measured: up to 3 weeks
Secondary outcomes (6)
Pulmonary function test - forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Measured: 1st day
Pulmonary function test - Forced expiratory volume in one second
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Measured: 1st day
Maximal inspiratory pressure
Maximal inspiratory pressure will be measured using a mouthpiece device.
Measured: 1st day
Maximal expiratory pressure
Maximal expiratory pressure will be measured using a mouthpiece device.
Measured: 1st day
Pulmonary function test - Peak expiratory flow
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Measured: 1st day
Pulmonary function test - Forced mid-expiratory flow (FEF25-75)
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Measured: 1stday
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start7 Oct 2020
- Primary completion7 Oct 2023
- Study completion7 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Ciliary DyskinesiaStudies of the same condition, open and under way.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Cakmak, Hacettepe University
- Investigators
- Deniz Inal-Ince, Study chair, Hacettepe UniversityUgur Ozcelik, Principal investigator, Hacettepe UniversityNagehan Emiralioglu, Principal investigator, Hacettepe UniversityMelda Saglam, Principal investigator, Hacettepe UniversityNaciye Vardar-Yagli, Principal investigator, Hacettepe UniversityEbru Calik-Kutukcu, Principal investigator, Hacettepe UniversityBirce Sunman, Principal investigator, Hacettepe UniversityHazal Sonbahar-Ulu, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712798
- Sponsor's protocol ID
- GO 20/647
- Status last verified
- Jun 2024
- First submitted
- 26 Jan 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cakmak-Onal A, Kocaaga E, Sonbahar-Ulu H, Calik E, Vardar-Yagli N, Saglam M, Sunman B, Emiralioglu N, Ozcelik U, Inal-Ince D. Physiological responses to cardiopulmonary and field exercise tests in primary ciliary dyskinesia compared with healthy peers. Eur J Appl Physiol. 2026 Apr;126(4):2051-2061. doi: 10.1007/s00421-025-06019-2. Epub 2025 Nov 4.
PubMed 41186743
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Responses to Exercise Tests in Primary Ciliary Dyskinesia Compared With Healthy Children and Investigation of the Relationship Between Exercise Capacity and Quality of Life in Primary Ciliary Dyskinesia
- ClinicalTrials.gov ID
- NCT05712798
- Acronym / sponsor ID
- GO 20/647
- Conditions
- Primary Ciliary Dyskinesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 7 Oct 2023 (actual)
- Study completion
- 7 Oct 2023 (actual)
- First posted
- 3 Feb 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.
The individuals with primary ciliary dyskinesia (PCD) have lower aerobic fitness and anaerobic performance than healthy individuals. Cardiopulmonary exercise test (CPET) provides an integrated assessment of integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems that are not adequately reflected by measurement of the function of organ systems. Maximum oxygen consumption is measured by performing gas exchange analysis with CPET, offering an objective measure of cardiorespiratory fitness. The six-minute walk test (6MWT) and the shuttle walk test (SWT) are field tests that produce oxygen consumption results similar to those during CPET. There is a need to determine the physiological responses to CPET, SWT and 6MWT in individuals with PCD. Additionally, the physiological responses of individuals with PCD to different exercise tests will be compared with the responses of healthy individuals. Low aerobic capacity in individuals with PCD may affect the physical, emotional, and social lives of individuals. This influence may cause a decrease in the quality of life of individuals with PCD. The relationship between exercise capacity and quality of life in individuals with PSD will be investigated with this study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The children with primary ciliary dyskinesia | – | Other: No interventionThe children with primary ciliary dyskinesia |
| Healthy controls | – | Other: No interventionHealthy children |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The children with primary ciliary dyskinesia and healthy children
Key inclusion criteria (5 listed)
- Having been diagnosed with PCD in the Pediatrics Department, Pediatric Chest Diseases Unit of Hacettepe University Faculty of Medicine and being routinely referred to Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit for physiotherapy applications and pulmonary rehabilitation program,
- Being clinically stable,
- Being between 8-18 years old,
- Having a forced expiratory volume in the first second (FEV1) ≥ 40%,
- The healthy group will be composed of individuals who do not have any known disease and volunteer to participate in the study. For healthy individuals, volunteers from acquaintances and/or relatives of the researchers will be included in the study.
Key exclusion criteria (4 listed)
- Having unstable clinical condition
- Having severe neuromuscular and musculoskeletal problems,
- Having any congenital heart diseases other than situs inversus,
- Unable to cooperate
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 |
|---|---|---|
| No interventionNo intervention | Other | Healthy controls, The children with primary ciliary dyskinesia |
Primary outcome
Shuttle walk test distance
Time frame: up to 3 weeks
Shuttle walk test distance will be determined using shuttle walk test
Quality of life score
Time frame: 1st day
Quality of life score will be determined using multidimensional measure to assess health-related quality of life in primary ciliary dyskinesia (QoL-PCD).
Maximal oxygen uptake
Time frame: up to 3 weeks
Maximal oxygen uptake will be determined using cardiopulmonary exercise test.
6 minute walk test distance
Time frame: up to 3 weeks
6 minute walk test distance will be determined using 6 minute walk test
6 secondary outcomes
Pulmonary function test - forced vital capacity
Time frame: 1st day
Pulmonary function test - Forced expiratory volume in one second
Time frame: 1st day
Maximal inspiratory pressure
Time frame: 1st day
Maximal expiratory pressure
Time frame: 1st day
Pulmonary function test - Peak expiratory flow
Time frame: 1st day
Pulmonary function test - Forced mid-expiratory flow (FEF25-75)
Time frame: 1stday
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 1 Jul 2024.
- Derived from this study: PubMed 41186743Cakmak-Onal A, Kocaaga E, Sonbahar-Ulu H, Calik E, Vardar-Yagli N, Saglam M, Sunman B, Emiralioglu N, Ozcelik U, Inal-Ince D. Physiological responses to cardiopulmonary and field exercise tests in primary ciliary dyskinesia compared with healthy peers. Eur J Appl Physiol. 2026 Apr;126(4):2051-2061. doi: 10.1007/s00421-025-06019-2. Epub 2025 Nov 4.
- Individual participant dataSharing planned: No
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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 study chair
Hacettepe University
Ugur Ozcelik principal investigator
Hacettepe University
Nagehan Emiralioglu 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 Primary Ciliary Dyskinesia, 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 5 inclusion and 4 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 1 Jul 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?
Shuttle walk test distance (time frame: up to 3 weeks). 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?
On the ClinicalTrials.gov record for NCT05712798, which also lists 1 linked publication.
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 1 Jul 2024.