Cystic FibrosisNCT04892485
Relationship of Skeletal Muscle Thickness, Strength, and Diaphragm Function in Adults With CF
An observational study of Cystic Fibrosis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
31 CF patients and 23 healthy sex and age-matched volunteers were enrolled. All subjects underwent pulmonary function tests, 6-minute walking tests. Body Mass Index and Fat Free Mass Index were measured via a body composition analyser. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 30 Apr 2018
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult CF patients and healty age sex matched controls
Who may be able to join
- CF diagnosed
- Age 18 and above
Who cannot join
- Having a pulmonary flare up within the previous month
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine
Istanbul
About this study
31 CF patients and 23 healthy sex and age-matched volunteers were enrolled. All subjects underwent pulmonary function tests, 6-minute walking tests. Body Mass Index and Fat Free Mass Index were measured via a body composition analyser. Diaphragm ultrasonography (to measure thickening fraction), quadriceps femoris muscle ultrasonography were performed. A dynamometer was used to measure each subjects handgrip strength.
- Conditions
- Cystic Fibrosis
- Keywords
- CF, nutritional status, peripheral muscle thickness, peripheral muscle strength, diaphragm thickening fraction
- Medical subject headings
- Cystic Fibrosis
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 |
|---|---|---|
| CF patients | Not described | |
| Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Thickness, Strength and Diaphragm Thickening Fraction of CF Patients
Measured via USG and handheld dynamometer
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Sep 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
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 Marmara 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berrin Ceyhan, Marmara University
- Investigators
- Berrin Ceyhan, Prof, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892485
- Sponsor's protocol ID
- 09.2016.341
- Status last verified
- May 2021
- First submitted
- 14 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Skeletal Muscle Thickness, Strength, and Diaphragm Function in Adults With CF
- ClinicalTrials.gov ID
- NCT04892485
- Acronym / sponsor ID
- 09.2016.341
- Conditions
- Cystic Fibrosis
- Keywords
- CF, nutritional status, peripheral muscle thickness, peripheral muscle strength, diaphragm thickening fraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 19 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.
31 CF patients and 23 healthy sex and age-matched volunteers were enrolled. All subjects underwent pulmonary function tests, 6-minute walking tests. Body Mass Index and Fat Free Mass Index were measured via a body composition analyser. Diaphragm ultrasonography (to measure thickening fraction), quadriceps femoris muscle ultrasonography were performed. A dynamometer was used to measure each subjects handgrip strength.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF patients | – | – |
| Controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult CF patients and healty age sex matched controls
Key inclusion criteria (2 listed)
- CF diagnosed
- Age 18 and above
Key exclusion criteria (2 listed)
- Having a pulmonary flare up within the previous month
- Pregnancy
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
Muscle Thickness, Strength and Diaphragm Thickening Fraction of CF Patients
Time frame: 2 months
Measured via USG and handheld dynamometer
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 2021.
- 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.
Berrin Ceyhan, Prof study chair
Marmara 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 Marmara 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 2 inclusion and 2 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 2021. 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?
Muscle Thickness, Strength and Diaphragm Thickening Fraction of CF Patients (time frame: 2 months). 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 19 May 2021.