Cystic FibrosisNCT06812793
Muscle Endurance in Children With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Cystic fibrosis (CF) is a genetic disorder affecting exocrine glands, leading to thick, viscous secretions that damage organs such as the lungs, pancreas, and reproductive system. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Measurement of Core Muscle Endurance, Respiratory Muscle Strength and Respiratory Muscle Endurance
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2025to 29 Dec 2025
- How long will I take part?
- 1 Day
- 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 age matched healthy volunteers who do not have any diagnosed chronic diseases
Who may be able to join
- Being between the ages of 6-18,
- Being diagnosed with Cystic Fibrosis according to the American Cystic Fibrosis Association consensus guideline,
- Having a forced expiratory volume in one second (FEV1) above 40% of the predicted value
- Being between the ages of 6-18
Who cannot join
- Not being able to cooperate with the assessment methods performed in the study
- Having an orthopedic, neurological, vestibular, etc. problem that may negatively affect the assessment methods performed in the study
- Having a history of exacerbation in the last month
- Having an organ transplantation history
- Using systemic corticosteroids
- Not being able to cooperate with the assessment methods performed in the study
- Having an orthopedic, neurological, vestibular, etc. problem that may negatively affect the assessment methods performed in the study
- Having had a respiratory tract infection in the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Children With Cystic Fibrosis Differ in Muscle Endurance? A Comparative Study
Cystic fibrosis (CF) is a genetic disorder affecting exocrine glands, leading to thick, viscous secretions that damage organs such as the lungs, pancreas, and reproductive system. Respiratory failure from CF lung disease is a major cause of morbidity and mortality, with chronic inflammation and infections disrupting mucociliary clearance. This results in declining respiratory functions, muscle strength, physical inactivity, and quality of life. While some studies compare respiratory and lower extremity muscle endurance in children with CF, none have evaluated core muscle endurance. This study aims to compare respiratory muscle strength, endurance, and muscle endurance in the core and lower extremities between children with CF and healthy peers.
Read the detailed description
Cystic fibrosis (CF) is an autosomal recessive genetic disease characterized by the involvement of exocrine glands, resulting from a disorder in the synthesis or function of the Cystic Fibrosis Transmembrane Regulator (CFTR) protein. The CFTR protein is responsible for ion and water transport in the cell epithelium. Dysfunction of this protein causes the secretion produced to be deficient in water. Viscous secretion, which is difficult to remove from its environment, causes permanent damage to many organs and systems such as the lungs, pancreas, hepatobiliary system and reproductive system. Respiratory failure due to CF lung disease is the most important cause of morbidity and mortality. The basic mechanism in the pathophysiology of CF lung disease is chronic inflammation and recurrent infections that occur as a result of the disruption of mucociliary clearance by sticky secretions. This vicious cycle causes obstruction in the airways and leads to progressive losses in respiratory functions. The decrease in respiratory functions; loss of muscle strength, reduced functional capacity, physical inactivity and reduced quality of life. There are limited studies in the literature comparing the respiratory muscle strength, respiratory muscle endurance and lower extremity muscle endurance of children with CF with their healthy peers. However, there is no study evaluating the core muscle endurance of children with CF. This study aims to compare the respiratory muscle strength, respiratory muscle endurance, core muscle endurance and lower extremity muscle endurance in children with CF and their healthy peers.
- Conditions
- Cystic Fibrosis
- Being tested
- Measurement of Core Muscle Endurance, Respiratory Muscle Strength, Respiratory Muscle Endurance, Peripheral Muscle Endurance
- Keywords
- Pediatric chest diseases, core muscle endurance, respiratory muscles, sit-to-stand test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Core Muscle EnduranceOther
Endurance of the flexor, extensor and lateral trunk muscles will be assessed using the McGill Trunk Endurance Tests.
Respiratory Muscle StrengthOther
Inspiratory and expiratory muscle strength will be made with a portable, electronic intra-oral pressure measuring device.
Respiratory Muscle EnduranceOther
Respiratory muscle endurance testing will be measured using an inspiratory muscle training device at increasing threshold load.
Peripheral Muscle EnduranceOther
Peripheral muscle endurance will be assessed by performing 30 and 60 second sit-to-stand tests.
| Study group | Role | What they receive |
|---|---|---|
| Children with cystic fibrosis | Children diagnosed cystic fibrosis Receives: Other: Measurement of Core Muscle Endurance; Other: Respiratory Muscle Strength; Other: Respiratory Muscle Endurance; Other: Peripheral Muscle Endurance | |
| Healthy children | Age-matched healthy volunteers Receives: Other: Measurement of Core Muscle Endurance; Other: Respiratory Muscle Strength; Other: Respiratory Muscle Endurance; Other: Peripheral Muscle Endurance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core muscles endurance
Endurance of the flexor, extensor and lateral trunk muscles will be assessed using the McGill Trunk Endurance Tests.
Measured: Baseline
Secondary outcomes (3)
Respiratory Muscle Strength
Inspiratory and expiratory muscle strength will be made with a portable, electronic intra-oral pressure measuring device.
Measured: Baseline
Respiratory muscle endurance
Respiratory muscle endurance testing will be measured using an inspiratory muscle training device at increasing threshold load.
Measured: Baseline
Peripheral muscle endurance
Peripheral muscle endurance will be assessed by performing 30 and 60 second sit-to-stand tests.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start5 Feb 2025
- Primary completion3 Nov 2025
- Study completion29 Dec 2025
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 Bezmialem Vakif 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
- 48 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Çınar, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812793
- Sponsor's protocol ID
- bvubcinar02
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Children With Cystic Fibrosis Differ in Muscle Endurance? A Comparative Study
- ClinicalTrials.gov ID
- NCT06812793
- Acronym / sponsor ID
- bvubcinar02
- Conditions
- Cystic Fibrosis
- Keywords
- Pediatric chest diseases, core muscle endurance, respiratory muscles, sit-to-stand test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 6 Feb 2025 (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.
Cystic fibrosis (CF) is a genetic disorder affecting exocrine glands, leading to thick, viscous secretions that damage organs such as the lungs, pancreas, and reproductive system. Respiratory failure from CF lung disease is a major cause of morbidity and mortality, with chronic inflammation and infections disrupting mucociliary clearance. This results in declining respiratory functions, muscle strength, physical inactivity, and quality of life. While some studies compare respiratory and lower extremity muscle endurance in children with CF, none have evaluated core muscle endurance. This study aims to compare respiratory muscle strength, endurance, and muscle endurance in the core and lower extremities between children with CF and healthy peers.
Detailed description
Cystic fibrosis (CF) is an autosomal recessive genetic disease characterized by the involvement of exocrine glands, resulting from a disorder in the synthesis or function of the Cystic Fibrosis Transmembrane Regulator (CFTR) protein. The CFTR protein is responsible for ion and water transport in the cell epithelium. Dysfunction of this protein causes the secretion produced to be deficient in water. Viscous secretion, which is difficult to remove from its environment, causes permanent damage to many organs and systems such as the lungs, pancreas, hepatobiliary system and reproductive system. Respiratory failure due to CF lung disease is the most important cause of morbidity and mortality. The basic mechanism in the pathophysiology of CF lung disease is chronic inflammation and recurrent infections that occur as a result of the disruption of mucociliary clearance by sticky secretions. This vicious cycle causes obstruction in the airways and leads to progressive losses in respiratory functions. The decrease in respiratory functions; loss of muscle strength, reduced functional capacity, physical inactivity and reduced quality of life. There are limited studies in the literature comparing the respiratory muscle strength, respiratory muscle endurance and lower extremity muscle endurance of children with CF with their healthy peers. However, there is no study evaluating the core muscle endurance of children with CF. This study aims to compare the respiratory muscle strength, respiratory muscle endurance, core muscle endurance and lower extremity muscle endurance in children with CF and their healthy peers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with cystic fibrosis | – | Other: Measurement of Core Muscle Endurance, Other: Respiratory Muscle Strength, Other: Respiratory Muscle Endurance, Other: Peripheral Muscle EnduranceChildren diagnosed cystic fibrosis |
| Healthy children | – | Other: Measurement of Core Muscle Endurance, Other: Respiratory Muscle Strength, Other: Respiratory Muscle Endurance, Other: Peripheral Muscle EnduranceAge-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 age matched healthy volunteers who do not have any diagnosed chronic diseases
Key inclusion criteria (4 listed)
- Being between the ages of 6-18,
- Being diagnosed with Cystic Fibrosis according to the American Cystic Fibrosis Association consensus guideline,
- Having a forced expiratory volume in one second (FEV1) above 40% of the predicted value
- Being between the ages of 6-18
Key exclusion criteria (8 listed)
- Not being able to cooperate with the assessment methods performed in the study
- Having an orthopedic, neurological, vestibular, etc. problem that may negatively affect the assessment methods performed in the study
- Having a history of exacerbation in the last month
- Having an organ transplantation history
- Using systemic corticosteroids
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 Core Muscle EnduranceEndurance of the flexor, extensor and lateral trunk muscles will be assessed using the McGill Trunk Endurance Tests. | Other | Children with cystic fibrosis, Healthy children |
| Respiratory Muscle StrengthInspiratory and expiratory muscle strength will be made with a portable, electronic intra-oral pressure measuring device. | Other | Children with cystic fibrosis, Healthy children |
| Respiratory Muscle EnduranceRespiratory muscle endurance testing will be measured using an inspiratory muscle training device at increasing threshold load. | Other | Children with cystic fibrosis, Healthy children |
| Peripheral Muscle EndurancePeripheral muscle endurance will be assessed by performing 30 and 60 second sit-to-stand tests. | Other | Children with cystic fibrosis, Healthy children |
Primary outcome
Core muscles endurance
Time frame: Baseline
Endurance of the flexor, extensor and lateral trunk muscles will be assessed using the McGill Trunk Endurance Tests.
3 secondary outcomes
Respiratory Muscle Strength
Time frame: Baseline
Respiratory muscle endurance
Time frame: Baseline
Peripheral muscle endurance
Time frame: Baseline
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 6 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 4 inclusion and 8 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 6 Jan 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?
Core muscles endurance (time frame: Baseline). 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 6 Jan 2026.