Primary Ciliary DyskinesiaNCT04161313
Respiratory Function, Exercise Capacity and Peripheral Muscle Strength Among Patients With CF, PCD and Healthy Children
An observational study of Primary Ciliary Dyskinesia and Cystic Fibrosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare pulmonary function, respiratory muscle strength, exercise capacity and peripheral muscle strength of patients with CF, PCD and healthy childrens. 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, Cystic Fibrosis
- What is being tested?
- Measurement of functional capacity, pulmonary function test and Functional capacity
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2019to 12 Mar 2020
- 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: Children diagnosed with cystic fibrosis and primary ciliary dyskinesia and age matched healthy volunteers who do not have any diagnosed chronic diseases
Who may be able to join
- Diagnosis of cystic fibrosis or primary ciliary dyskinesia
Who cannot join
- Hospitalization history in past month
- Diagnosis of other chronic pediatric diseases which may impair exercise tolerance such as cerebral palsy or neuromuscular disease
- Candidates for lung transplantation or history of lung transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Respiratory Function, Exercise Capacity and Peripheral Muscle Strength Among Patients With Cystic Fibrosis, Primary Ciliary Dyskinesia and Healthy Children
The aim of this study is to compare pulmonary function, respiratory muscle strength, exercise capacity and peripheral muscle strength of patients with CF, PCD and healthy childrens.
Read the detailed description
The impaired airway clearence and pulmonary functions, exercise intolerance, low physical activity level and decreased peripheral muscle strength make physiotherapy approaches important in the management of CF and PCD.
- Conditions
- Primary Ciliary Dyskinesia, Cystic Fibrosis
- Being tested
- Measurement of functional capacity, pulmonary function test, Functional capacity, Peripheral muscle strength, Respiratory muscle strength
- Keywords
- respiratory functions, exercise capacity, muscle strength
- Medical subject headings
- Ciliary Motility Disorders, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of functional capacityOther
Functional capacity of participants will be measured with six-minute walk test.
pulmonary function testOther
It will be measured using basic spirometry and presented lung volume parameters such as FEV1,FVC,FEV1/FVC,PEF, FEF25-75
Functional capacityOther
Functional capacity of participants will be measured with six-minute walk test and sit-to-stand test
Peripheral muscle strengthOther
Isometric M. Quadriceps strength will be measured using electronic hand held dynamometer in sitting position.
Respiratory muscle strengthOther
Inspiratory and expiratory muscle strength has been assessed by maximal inspiratory and expiratory mouth pressures.
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis | children with cystic fibrosis Receives: Other: Measurement of functional capacity; Other: pulmonary function test; Other: Functional capacity; Other: Peripheral muscle strength; Other: Respiratory muscle strength | |
| primary ciliary dyskinesia | children with primary ciliary dyskinesia Receives: Other: Measurement of functional capacity; Other: pulmonary function test; Other: Functional capacity; Other: Peripheral muscle strength; Other: Respiratory muscle strength | |
| healthy controls | Age-matched healthy volunteers Receives: Other: Measurement of functional capacity; Other: pulmonary function test; Other: Functional capacity; Other: Peripheral muscle strength; Other: Respiratory muscle strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test distance
Distance walked in six minutes will be recorded in meters. Test will be conducted according to the guideline of American Thoracic Society (ATS).
Measured: 15 minutes
Secondary outcomes (4)
Forced Vital Capacity (FVC)
FVC will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
Measured: 5 minutes
Forced Expiratory Volume in 1 second (FEV1)
FEV1 will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
Measured: 5 minutes
Peak Expiratory Flow (PEF)
PEF will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
Measured: 5 minutes
M. Quadriceps strength
Isometric M. Quadriceps strength (kg) will be measured using electronic hand held dynamometer in sitting position.
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 posted13 Nov 2019
- Study start20 Dec 2019
- Primary completion24 Feb 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Denizoğlu Külli, Bezmialem Vakif University
- Investigators
- Hilal Denizoglu Kulli, PhD, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161313
- Sponsor's protocol ID
- hdenizkulli2
- Status last verified
- Mar 2020
- First submitted
- 8 Nov 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Respiratory Function, Exercise Capacity and Peripheral Muscle Strength Among Patients With Cystic Fibrosis, Primary Ciliary Dyskinesia and Healthy Children
- ClinicalTrials.gov ID
- NCT04161313
- Acronym / sponsor ID
- hdenizkulli2
- Conditions
- Primary Ciliary Dyskinesia, Cystic Fibrosis
- Keywords
- respiratory functions, exercise capacity, muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 13 Nov 2019 (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 aim of this study is to compare pulmonary function, respiratory muscle strength, exercise capacity and peripheral muscle strength of patients with CF, PCD and healthy childrens.
Detailed description
The impaired airway clearence and pulmonary functions, exercise intolerance, low physical activity level and decreased peripheral muscle strength make physiotherapy approaches important in the management of CF and PCD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis | – | Other: Measurement of functional capacity, Other: pulmonary function test, Other: Functional capacity, Other: Peripheral muscle strength, Other: Respiratory muscle strengthchildren with cystic fibrosis |
| primary ciliary dyskinesia | – | Other: Measurement of functional capacity, Other: pulmonary function test, Other: Functional capacity, Other: Peripheral muscle strength, Other: Respiratory muscle strengthchildren with primary ciliary dyskinesia |
| healthy controls | – | Other: Measurement of functional capacity, Other: pulmonary function test, Other: Functional capacity, Other: Peripheral muscle strength, Other: Respiratory muscle strengthAge-matched healthy volunteers |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed with cystic fibrosis and primary ciliary dyskinesia and age matched healthy volunteers who do not have any diagnosed chronic diseases
Key inclusion criteria (1 listed)
- Diagnosis of cystic fibrosis or primary ciliary dyskinesia
Key exclusion criteria (3 listed)
- Hospitalization history in past month
- Diagnosis of other chronic pediatric diseases which may impair exercise tolerance such as cerebral palsy or neuromuscular disease
- Candidates for lung transplantation or history of lung transplantation
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 |
|---|---|---|
| Measurement of functional capacityFunctional capacity of participants will be measured with six-minute walk test. | Other | Cystic fibrosis, healthy controls, primary ciliary dyskinesia |
| pulmonary function testIt will be measured using basic spirometry and presented lung volume parameters such as FEV1,FVC,FEV1/FVC,PEF, FEF25-75 | Other | Cystic fibrosis, healthy controls, primary ciliary dyskinesia |
| Functional capacityFunctional capacity of participants will be measured with six-minute walk test and sit-to-stand test | Other | Cystic fibrosis, healthy controls, primary ciliary dyskinesia |
| Peripheral muscle strengthIsometric M. Quadriceps strength will be measured using electronic hand held dynamometer in sitting position. | Other | Cystic fibrosis, healthy controls, primary ciliary dyskinesia |
| Respiratory muscle strengthInspiratory and expiratory muscle strength has been assessed by maximal inspiratory and expiratory mouth pressures. | Other | Cystic fibrosis, healthy controls, primary ciliary dyskinesia |
Primary outcome
Six-minute walk test distance
Time frame: 15 minutes
Distance walked in six minutes will be recorded in meters. Test will be conducted according to the guideline of American Thoracic Society (ATS).
4 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: 5 minutes
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 5 minutes
Peak Expiratory Flow (PEF)
Time frame: 5 minutes
M. Quadriceps strength
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 18 Mar 2020.
- 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.
Hilal Denizoglu Kulli, PhD study director
Bezmialem Vakif 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 and Cystic Fibrosis, run by Bezmialem Vakif 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 3 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 18 Mar 2020. 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?
Six-minute walk test distance (time frame: 15 minutes). 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 18 Mar 2020.