Cystic FibrosisNCT06088485
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
An observational study of Cystic Fibrosis and Postural Defect, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted in the age range of 18-45 December, who were diagnosed with Cystic fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Postural Defect, Pulmonary Disease
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2023to 16 Feb 2024
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients referred by the department of chest diseases of Hacettepe University will be taken
Who may be able to join
- Patients aged between 18-45 who were diagnosed with Cystic Fibrosis
Who cannot join
- In the last year, patients;
- who had a fracture in any part of the patient's body
- who had undergone spine surgery
- who had an orthopedic, neurological or metastatic history in addition to Cystic Fibrosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University, Health Sciences Faculty
Ankara, 06100
Aynur demirel, PhD, +903052525 ext. 168, aynur.demirel@hacettepe.edu.tr
Aysu Yalman
About this study
Official title: Erişkin Kistik Fibrozisli Bireylerde Kemik Mineral Yoğunluğunun Postür, Solunum Fonksiyonları ve Fonksiyonel Egzersiz Kapasitesi Üzerine Etkisi
The study was conducted in the age range of 18-45 December, who were diagnosed with Cystic fibrosis.
Read the detailed description
60 voluntary patients who have signed the consent form will be included. Within the scope of the research the demographic information of the individuals will be recorded. Functional capacities of individuals With the Shuttle Walking Test at Increasing Speed, respiratory functions respiratory function test, with measurements of respiratory November muscle strength and endurance, the level of dyspnea was Modified Medical Peripheral November muscle strength hand dynamometers with Research Council (mMRC) Dyspnea Scale posture assessment with the Corbin Posture Analysis Scale, trunk mobility with the Trunk Pelvis-Hip Angle Test, core stabilization with Sahrmann's Core Stability Test, individuals' perception of cosmetic deformity Walter Reed visual assessment questionnaires
- Medical subject headings
- Cystic Fibrosis, Lung Diseases, Sedentary Behavior
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 |
|---|---|---|
| low bone mineral density | bone mineral density according to t and z score. | |
| normal bone mineral density | bone mineral density according to t and z score. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Exercise Capacity
Functional exercise capacity by incremental shuttle walk test in patients with adult Cystic Fibrosis
Measured: 1 day
Secondary outcomes (1)
Posture
posture by Corbin Posture Analysis Form in patients with adult Cystic Fibrosis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start5 Sep 2023
- Primary completion22 Jan 2024 (estimated)
- Study completion16 Feb 2024 (estimated)
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 Hacettepe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Demirel, Hacettepe University
- Investigators
- Aynur Demirel, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088485
- Sponsor's protocol ID
- GO22/126
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erişkin Kistik Fibrozisli Bireylerde Kemik Mineral Yoğunluğunun Postür, Solunum Fonksiyonları ve Fonksiyonel Egzersiz Kapasitesi Üzerine Etkisi
- ClinicalTrials.gov ID
- NCT06088485
- Acronym / sponsor ID
- GO22/126
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 22 Jan 2024 (estimated)
- Study completion
- 16 Feb 2024 (estimated)
- First posted
- 18 Oct 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 study was conducted in the age range of 18-45 December, who were diagnosed with Cystic fibrosis.
Detailed description
60 voluntary patients who have signed the consent form will be included. Within the scope of the research the demographic information of the individuals will be recorded. Functional capacities of individuals With the Shuttle Walking Test at Increasing Speed, respiratory functions respiratory function test, with measurements of respiratory November muscle strength and endurance, the level of dyspnea was Modified Medical Peripheral November muscle strength hand dynamometers with Research Council (mMRC) Dyspnea Scale posture assessment with the Corbin Posture Analysis Scale, trunk mobility with the Trunk Pelvis-Hip Angle Test, core stabilization with Sahrmann's Core Stability Test, individuals' perception of cosmetic deformity Walter Reed visual assessment questionnaires
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low bone mineral density | – | –bone mineral density according to t and z score. |
| normal bone mineral density | – | –bone mineral density according to t and z score. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients referred by the department of chest diseases of Hacettepe University will be taken
Key inclusion criteria (1 listed)
- Patients aged between 18-45 who were diagnosed with Cystic Fibrosis
Key exclusion criteria (4 listed)
- In the last year, patients;
- who had a fracture in any part of the patient's body
- who had undergone spine surgery
- who had an orthopedic, neurological or metastatic history in addition to Cystic Fibrosis
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
Functional Exercise Capacity
Time frame: 1 day
Functional exercise capacity by incremental shuttle walk test in patients with adult Cystic Fibrosis
1 secondary outcome
Posture
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
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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.
Aynur Demirel 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 Cystic Fibrosis and Postural Defect, 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 1 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aynur Demirel, PhD (05545295057, aynurdemirel629@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Exercise Capacity (time frame: 1 day). 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 14 Nov 2023.