Primary Ciliary DyskinesiaNCT04895150
Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance in Patients With Primary Ciliary Dyskinesia
An observational study of Primary Ciliary Dyskinesia, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial summary
The main aim of the study is to evaluate upper extremity exercise capacity and muscle oxygenation in patients with primary ciliary dyskinesia. The secondary aim of the study is to evaluate respiratory function, respiratory muscle strength and endurance, peripheral muscle strength, balance, physical activity level and… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Ciliary Dyskinesia
- How many people
- 54 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 15 May 2022
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: At least 18 patients with primary ciliary dyskinesia will be included in patients group and 18 healthy individuals will be included in control group.
Who may be able to join
- Patients;
- 6-18 years old
- Diagnosed with primary ciliary dyskinesia
- Stability of clinical condition
- Healthy controls;
- 6-18 years old
Who cannot join
- Patients;
- Diagnosed neurological, cognitive problem that can affect evaluations,
- Acute pneumonia or any infection
- History of exacerbation in the last 1 month
- More than 10% change in FEV1 in the last 6 months
- History of coronavirus disease (COVID-19)
Show all 15Show fewer
- History of smoking
- Diagnosed vision, hearing, vestibular, or neurological problems that can affect balance
- Diagnosed orthopedic problems affecting mobility or a history of musculoskeletal surgery
- Healthy controls;
- Diagnosed neurological, cognitive problem that can affect evaluations
- Diagnosed vision, hearing, vestibular, or neurological problems that can affect balance
- History of coronavirus disease (COVID-19)
- History of smoking
- Trouble understanding and following the exercise test instruction
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gazi University, Faculty of Health Science
Ankara
Gazi University
Ankara
About this study
Official title: Investigation of Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance and Physical Activity Levels in Patients With Primary Ciliary Dyskinesia
The main aim of the study is to evaluate upper extremity exercise capacity and muscle oxygenation in patients with primary ciliary dyskinesia. The secondary aim of the study is to evaluate respiratory function, respiratory muscle strength and endurance, peripheral muscle strength, balance, physical activity level and quality of life in patients with primary ciliary dyskinesia and compare all parameters with healthy controls.
Read the detailed description
Primary ciliary dyskinesia (PCD) is a genetic, heterogeneous disease caused by cilia absence or dysfunction. Impaired function of motile cilia leads to impaired mucociliary clearance, recurrent chest infections, and progressive destruction of the lung structure. Clinical features include neonatal respiratory distress syndrome, chronic daily productive cough, chronic nasal congestion, and chronic or recurrent otitis media.
Pulmonary functions, exercise capacity, respiratory muscle strength and endurance, peripheral muscle strength, physical activity level and quality of life were affected in patients. The number of studies on these subjects is limited.
Pulmonary function and extremity muscle strength are determinants of exercise capacity in chronic obstructive pulmonary disease. Decreased strength and endurance in the limb muscles is associated with exercise intolerance. Patients have decreased upper extremity muscle strength. There is no study in the literature evaluating upper extremity exercise capacity in patients with PCD. Measuring the oxygen saturation of cardiorespiratory and peripheral muscles is important for understanding the dynamics of oxygen delivery and consumption during exercise. There are no studies in the literature evaluating muscle oxygenation in this patient population.
The main aim of the study is to evaluate upper extremity exercise capacity and muscle oxygenation in patients with primary ciliary dyskinesia. The secondary aim of the study is to evaluate respiratory function, respiratory muscle strength and endurance, peripheral muscle strength, balance, physical activity level and quality of life in patients with primary ciliary dyskinesia and compare them with healthy controls.
The study was planned cross-sectional. Patients with primary ciliary dyskinesia referred to the Cardiopulmonary Rehabilitation Unit of Gazi University Physiotherapy and Rehabilitation Department by the physicians of the Department of Pediatric Pulmonary Diseases of Gazi University Faculty of Medicine will be included in the study. At least 18 patients with primary ciliary dyskinesia and at least 18 healthy controls of similar age and sex will be evaluated in the study. The assessments will be completed in two days.
Upper extremity exercise capacity (6 minutes Pegboard and Ring Test), muscle oxygenation ("Moxy" monitor), functional exercise capacity(6 minutes walk test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), respiratory muscle endurance (incremental threshold loading test), peripheral muscle strength (dynamometer), balance("Biodex Balance System®" and Y balance test), physical activity level (multi-sensor activity monitor) and quality of life (Quality of Life scale for Primary Ciliary Dyskinesia (QOL-PCD scale version 4.3) will be evaluated.
- Conditions
- Primary Ciliary Dyskinesia
- Keywords
- Primary Ciliary Dyskinesia, Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance, Physical Activity
- Medical subject headings
- Ciliary Motility Disorders, Motor Activity
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 |
|---|---|---|
| Patients | Upper extremity exercise capacity (6 minutes Pegboard and Ring Test), muscle oxygenation ("Moxy" monitor), functional exercise capacity(6 minutes walk test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), respiratory muscle endurance (incremental threshold loading test), peripheral muscle strength (dynamometer), balance("Biodex Balance System®" and Y balance test), physical activity level (multi-sensor activity monitor) and quality of life (Quality of Life scale for Primary Ciliary Dyskinesia (QOL-PCD scale version 4.3)) will be evaluated. | |
| Healthy controls; | Upper extremity exercise capacity (6 minutes Pegboard and Ring Test), muscle oxygenation ("Moxy" monitor), functional exercise capacity(6 minutes walk test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), respiratory muscle endurance (incremental threshold loading test), peripheral muscle strength (dynamometer), balance("Biodex Balance System®" and Y balance test), physical activity level (multi-sensor activity monitor) and quality of life (Quality of Life scale for Primary Ciliary Dyskinesia (QOL-PCD scale version 4.3)) will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity exercise capacity
Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT). A pegboard with two upper and lower bars set at participants shoulder level and above the shoulder level will used. Ten rings will placed on both the lower bars. Patients will be asked to move a single ring at a time with both hands from the lower bars to the upper. The score is the total number of rings moved the six-minute period.
Measured: First Day
Muscle Oxygenation
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). The device will be placed on the 1/3 lower motor point of the quadriceps muscle group of the dominant leg and on the dominant arm deltoid muscle. A minimum of 3 minutes will be waited until the resting measurements and skeletal muscle oxygenation (StO2) signal stabilize. The measurements will be repeated during six minute walking test and six minute pegboard and ring test.
Measured: First Day
Secondary outcomes (17)
Functional exercise capacity
Functional exercise capacity will be evaluated with 6-minute walking test according to the American Thoracic Society and European Respiratory Society criteria.
Measured: First Day
Balance
Static balance assessment will be evaluated using the "Biodex Balance System®". The test period will be 20 seconds, and there will be a 10-second break between evaluations. General stability index, anterior / posterior (AP) stability index, medial / lateral (ML) stability index and their standard deviations will be obtained from the system as a result of the test. The tests will first be carried out on the hard ground with open eyes. The tests will second be carried out on the hard ground with closed eyes. The tests will third be carried out on the soft ground with open eyes. Dynamic balance will be evaluated with the Y balance test.
Measured: Second day
Physical activity (Total energy expenditure)
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second day
Physical activity (Active energy expenditure (joule / day)
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second day
Physical activity (Physical activity time (min / day)
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day
Physical activity (Average metabolic equivalent (MET / day)
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day
Physical activity (Number of steps (steps / day)
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day
Physical activity (Time spent lying down (min / day) days)
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day
Physical activity (Sleep time (min / day)
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 3 continuous days. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: Second Day
Respiratory muscle strength
Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be measured with a portable mouth pressure measuring device according to American Thoracic Society and European Respiratory Society criteria.
Measured: First day
Respiratory muscle endurance
Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load. The test will be started with 20% of the maximal inspiratory pressure and the pressure will be increased to 40%, 60%, 80% and 100% every two minutes. Patients will be asked to continue breathing through the device during the test. If the individual cannot breathe 3 consecutive times, the test will be terminated by the physiotherapist. During the test, the number of breaths delivered and the maximal time reached during each 2-minute period will be recorded.The total duration of the test and the maximum pressure value at which it continues to breathe for at least 1 minute will be multiplied. The value found will be recorded as the respiratory muscle endurance value.
Measured: Second Day
Pulmonary function (Forced vital capacity (FVC))
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured.
Measured: First Day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced expiratory volume in the first second (FEV1) will be measured.
Measured: First Day
Pulmonary function (FEV1 / FVC)
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.
Measured: First Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured.
Measured: First Day
Pulmonary function (Peak flow rate (PEF))
Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured.
Measured: First Day
Life quality
Quality of life will be evaluated with the Quality of Life scale for Primary Ciliary Dyskinesia (QOL-PCD scale version 4.3)(Turkish version). The scale have well-established reliability and validity. There are four separate versions of QOL-PCD for three separate age-appropriate.The scale includes questions about physical function, emotional function, social function, respiratory symptoms, treatment burden, hearing symptoms, role, health perceptions, vitality, eating and weight. The scale included sub-groups involving different situations according to the different ages. The total numbers of items in the scale are 37 in the questionnaire for children, 43 in the one for adolescents, 49 in the one for adults, 41 in the parents of the patients in the age group of 6-12 years. Items are rated according to a 4-point scale. Higher scores indicate better quality of life.
Measured: Second day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Jun 2021
- Primary completion30 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Primary Ciliary DyskinesiaStudies of the same condition, open and under way.
- More trials run by Gazi 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Meral Boşnak Güçlü, Prof.Dr., Study director, Gazi UniversityŞeyma Mutlu, Pt., Study chair, Gazi UniversityTuğba ŞİŞMANLAR EYÜBOĞLU, Asc.Prof.Dr., Principal investigator, Gazi UniversityAyşe Tana ARSLAN, Prof.Dr., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895150
- Sponsor's protocol ID
- Gazi University 408
- Status last verified
- May 2022
- First submitted
- 17 May 2021
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valerio G, Giallauria F, Montella S, Vaino N, Vigorito C, Mirra V, Santamaria F. Cardiopulmonary assessment in primary ciliary dyskinesia. Eur J Clin Invest. 2012 Jun;42(6):617-22. doi: 10.1111/j.1365-2362.2011.02626.x. Epub 2011 Nov 29.
PubMed 22121832Ring AM, Buchvald FF, Holgersen MG, Green K, Nielsen KG. Fitness and lung function in children with primary ciliary dyskinesia and cystic fibrosis. Respir Med. 2018 Jun;139:79-85. doi: 10.1016/j.rmed.2018.05.001. Epub 2018 May 3.
PubMed 29858006Madsen A, Green K, Buchvald F, Hanel B, Nielsen KG. Aerobic fitness in children and young adults with primary ciliary dyskinesia. PLoS One. 2013 Aug 19;8(8):e71409. doi: 10.1371/journal.pone.0071409. eCollection 2013.
PubMed 23977038Behan L, Rubbo B, Lucas JS, Dunn Galvin A. The patient's experience of primary ciliary dyskinesia: a systematic review. Qual Life Res. 2017 Sep;26(9):2265-2285. doi: 10.1007/s11136-017-1564-y. Epub 2017 Mar 30.
PubMed 28361274Denizoglu Kulli H, Gurses HN, Zeren M, Ucgun H, Cakir E. Do pulmonary and extrapulmonary features differ among cystic fibrosis, primary ciliary dyskinesia, and healthy children? Pediatr Pulmonol. 2020 Nov;55(11):3067-3073. doi: 10.1002/ppul.25052. Epub 2020 Sep 11.
PubMed 32877003Mutlu Kayaarslan S, Bosnak Guclu M, Sismanlar Eyuboglu T, Aslan AT. Balance Impairment, Muscle Oxygenation, and Functional Exercise Capacity in Patients With Primary Ciliary Dyskinesia. Pediatr Pulmonol. 2026 Apr;61(4):e71605. doi: 10.1002/ppul.71605.
PubMed 41928622
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance and Physical Activity Levels in Patients With Primary Ciliary Dyskinesia
- ClinicalTrials.gov ID
- NCT04895150
- Acronym / sponsor ID
- Gazi University 408
- Conditions
- Primary Ciliary Dyskinesia
- Keywords
- Primary Ciliary Dyskinesia, Upper Extremity Exercise Capacity, Muscle Oxygenation, Balance, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 20 May 2021 (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 main aim of the study is to evaluate upper extremity exercise capacity and muscle oxygenation in patients with primary ciliary dyskinesia. The secondary aim of the study is to evaluate respiratory function, respiratory muscle strength and endurance, peripheral muscle strength, balance, physical activity level and quality of life in patients with primary ciliary dyskinesia and compare all parameters with healthy controls.
Detailed description
Primary ciliary dyskinesia (PCD) is a genetic, heterogeneous disease caused by cilia absence or dysfunction. Impaired function of motile cilia leads to impaired mucociliary clearance, recurrent chest infections, and progressive destruction of the lung structure. Clinical features include neonatal respiratory distress syndrome, chronic daily productive cough, chronic nasal congestion, and chronic or recurrent otitis media.
Pulmonary functions, exercise capacity, respiratory muscle strength and endurance, peripheral muscle strength, physical activity level and quality of life were affected in patients. The number of studies on these subjects is limited.
Pulmonary function and extremity muscle strength are determinants of exercise capacity in chronic obstructive pulmonary disease. Decreased strength and endurance in the limb muscles is associated with exercise intolerance. Patients have decreased upper extremity muscle strength. There is no study in the literature evaluating upper extremity exercise capacity in patients with PCD. Measuring the oxygen saturation of cardiorespiratory and peripheral muscles is important for understanding the dynamics of oxygen delivery and consumption during exercise. There are no studies in the literature evaluating muscle oxygenation in this patient population.
The main aim of the study is to evaluate upper extremity exercise capacity and muscle oxygenation in patients with primary ciliary dyskinesia. The secondary aim of the study is to evaluate respiratory function, respiratory muscle strength and endurance, peripheral muscle strength, balance, physical activity level and quality of life in patients with primary ciliary dyskinesia and compare them with healthy controls.
The study was planned cross-sectional. Patients with primary ciliary dyskinesia referred to the Cardiopulmonary Rehabilitation Unit of Gazi University Physiotherapy and Rehabilitation Department by the physicians of the Department of Pediatric Pulmonary Diseases of Gazi University Faculty of Medicine will be included in the study. At least 18 patients with primary ciliary dyskinesia and at least 18 healthy controls of similar age and sex will be evaluated in the study. The assessments will be completed in two days.
Upper extremity exercise capacity (6 minutes Pegboard and Ring Test), muscle oxygenation ("Moxy" monitor), functional exercise capacity(6 minutes walk test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), respiratory muscle endurance (incremental threshold loading test), peripheral muscle strength (dynamometer), balance("Biodex Balance System®" and Y balance test), physical activity level (multi-sensor activity monitor) and quality of life (Quality of Life scale for Primary Ciliary Dyskinesia (QOL-PCD scale version 4.3) will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Upper extremity exercise capacity (6 minutes Pegboard and Ring Test), muscle oxygenation ("Moxy" monitor), functional exercise capacity(6 minutes walk test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), respiratory muscle endurance (incremental threshold loading test), peripheral muscle strength (dynamometer), balance("Biodex Balance System®" and Y balance test), physical activity level (multi-sensor activity monitor) and quality of life (Quality of Life scale for Primary Ciliary Dyskinesia (QOL-PCD scale version 4.3)) will be evaluated. |
| Healthy controls; | – | –Upper extremity exercise capacity (6 minutes Pegboard and Ring Test), muscle oxygenation ("Moxy" monitor), functional exercise capacity(6 minutes walk test), respiratory functions (spirometer), respiratory muscle strength (mouth pressure measurement), respiratory muscle endurance (incremental threshold loading test), peripheral muscle strength (dynamometer), balance("Biodex Balance System®" and Y balance test), physical activity level (multi-sensor activity monitor) and quality of life (Quality of Life scale for Primary Ciliary Dyskinesia (QOL-PCD scale version 4.3)) will be evaluated. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- At least 18 patients with primary ciliary dyskinesia will be included in patients group and 18 healthy individuals will be included in control group.
Key inclusion criteria (6 listed)
- Patients;
- 6-18 years old
- Diagnosed with primary ciliary dyskinesia
- Stability of clinical condition
- Healthy controls;
Key exclusion criteria (15 listed)
- Patients;
- Diagnosed neurological, cognitive problem that can affect evaluations,
- Acute pneumonia or any infection
- History of exacerbation in the last 1 month
- More than 10% change in FEV1 in the last 6 months
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
Upper extremity exercise capacity
Time frame: First Day
Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT). A pegboard with two upper and lower bars set at participants shoulder level and above the shoulder level will used. Ten rings will placed on both the lower bars. Patients will be asked to move a single ring at a time with both hands from the lower bars to the upper. The score is the total number of rings moved the six-minute period.
Muscle Oxygenation
Time frame: First Day
Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA). The device will be placed on the 1/3 lower motor point of the quadriceps muscle group of the dominant leg and on the dominant arm deltoid muscle. A minimum of 3 minutes will be waited until the resting measurements and skeletal muscle oxygenation (StO2) signal stabilize. The measurements will be repeated during six minute walking test and six minute pegboard and ring test.
17 secondary outcomes
Functional exercise capacity
Time frame: First Day
Balance
Time frame: Second day
Physical activity (Total energy expenditure)
Time frame: Second day
Physical activity (Active energy expenditure (joule / day)
Time frame: Second day
Physical activity (Physical activity time (min / day)
Time frame: Second Day
Physical activity (Average metabolic equivalent (MET / day)
Time frame: Second Day
Physical activity (Number of steps (steps / day)
Time frame: Second Day
Physical activity (Time spent lying down (min / day) days)
Time frame: Second Day
Physical activity (Sleep time (min / day)
Time frame: Second Day
Respiratory muscle strength
Time frame: First day
Respiratory muscle endurance
Time frame: Second Day
Pulmonary function (Forced vital capacity (FVC))
Time frame: First Day
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time frame: First Day
Pulmonary function (FEV1 / FVC)
Time frame: First Day
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time frame: First Day
Pulmonary function (Peak flow rate (PEF))
Time frame: First Day
Life quality
Time frame: Second day
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 19 May 2022.
- Background: PubMed 22121832Valerio G, Giallauria F, Montella S, Vaino N, Vigorito C, Mirra V, Santamaria F. Cardiopulmonary assessment in primary ciliary dyskinesia. Eur J Clin Invest. 2012 Jun;42(6):617-22. doi: 10.1111/j.1365-2362.2011.02626.x. Epub 2011 Nov 29.
- Background: PubMed 29858006Ring AM, Buchvald FF, Holgersen MG, Green K, Nielsen KG. Fitness and lung function in children with primary ciliary dyskinesia and cystic fibrosis. Respir Med. 2018 Jun;139:79-85. doi: 10.1016/j.rmed.2018.05.001. Epub 2018 May 3.
- Background: PubMed 23977038Madsen A, Green K, Buchvald F, Hanel B, Nielsen KG. Aerobic fitness in children and young adults with primary ciliary dyskinesia. PLoS One. 2013 Aug 19;8(8):e71409. doi: 10.1371/journal.pone.0071409. eCollection 2013.
- Background: PubMed 28361274Behan L, Rubbo B, Lucas JS, Dunn Galvin A. The patient's experience of primary ciliary dyskinesia: a systematic review. Qual Life Res. 2017 Sep;26(9):2265-2285. doi: 10.1007/s11136-017-1564-y. Epub 2017 Mar 30.
- Background: PubMed 32877003Denizoglu Kulli H, Gurses HN, Zeren M, Ucgun H, Cakir E. Do pulmonary and extrapulmonary features differ among cystic fibrosis, primary ciliary dyskinesia, and healthy children? Pediatr Pulmonol. 2020 Nov;55(11):3067-3073. doi: 10.1002/ppul.25052. Epub 2020 Sep 11.
- Derived from this study: PubMed 41928622Mutlu Kayaarslan S, Bosnak Guclu M, Sismanlar Eyuboglu T, Aslan AT. Balance Impairment, Muscle Oxygenation, and Functional Exercise Capacity in Patients With Primary Ciliary Dyskinesia. Pediatr Pulmonol. 2026 Apr;61(4):e71605. doi: 10.1002/ppul.71605.
- 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.
Meral Boşnak Güçlü, Prof.Dr. study director
Gazi University
Şeyma Mutlu, Pt. study chair
Gazi University
Tuğba ŞİŞMANLAR EYÜBOĞLU, Asc.Prof.Dr. principal investigator
Gazi University
2 sites 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 Gazi University at 2 sites 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 6 inclusion and 15 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Upper extremity exercise capacity (time frame: First Day). The study lists 2 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 NCT04895150, which also lists 6 linked publications.
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 19 May 2022.