Idiopathic Pulmonary Fibrosis (IPF)NCT07178197
Sarcopenia in Patients With Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis (IPF) and Sarcopenia, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Sarcopenia negatively affects the prognosis of chronic diseases. However, the importance of sarcopenia in patients with idiopathic pulmonary fibrosis (IPF) has been less emphasized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF), Sarcopenia
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 31 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients included in the study were those diagnosed with IPF according to the ATS/ERS/JRS/ALAT 2022 guidelines and who applied to the Department of Pulmonary Diseases at Mersin University Faculty of Medicine.
Who may be able to join
- Being over 18 years of age
- Signing the informed consent form
- Having a diagnosis of IPF for at least one month
Who cannot join
- Pregnancy
- History of cancer within the last 5 years
- History of lung surgery
- History of neuromuscular disease
- Active pulmonary tuberculosis
- Active respiratory tract infection
Show all 10Show fewer
- Inability to perform pulmonary function tests
- Presence of a pacemaker
- History of systemic steroid use within the past 3 months
- Inability to use a hand dynamometer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Faculty of Medicine
Mersin, Mersin
About this study
Official title: Association of Sarcopenia With Quality of Life and Progression of Disease in Patients With Idiopathic Pulmonary Fibrosis
Sarcopenia negatively affects the prognosis of chronic diseases. However, the importance of sarcopenia in patients with idiopathic pulmonary fibrosis (IPF) has been less emphasized. The aim of the study is to determine the prevalence of sarcopenia in patients with IPF and to evaluate the impact of sarcopenia on quality of life and disease progression.
This study was designed as a descriptive cross-sectional. The study included patients diagnosed with IPF. Hand dynamometry and bioelectrical impedance analysis (BIA) were used to for diagnose of sarcopenia. Pulmonary function tests, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) measurements were examined. The 6-minute walk distance (6MWD) and 4-meter walking speed were recorded. The St. George Respiratory Questionnaire (SGRQ) was used to assess quality of life. All patients were evaluated for progressive disease.
Read the detailed description
The study was designed as a cross-sectional study.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF), Sarcopenia
- Keywords
- idiopathic pulmonary fibrosis, sarcopenia, skeletal muscle mass index, bioelectrical impedance analysis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Sarcopenia
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 |
|---|---|---|
| idiopathic pulmonary fibrosis (IPF) | The prevalence of sarcopenia was investigated in patients with IPF who met the inclusion and exclusion criteria. The relationship between sarcopenia and quality of life and disease progression in patients with IPF was evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Grip Strength
Hand Grip Strength (kg)- Grip strength measurement using a hand dynamometer
Measured: through study completion, an average of 1 year
SMI (skeletal muscle mass index)
SMI (skeletal muscle mass index) (kg/m2) - SMI measurement using the Bioelectrical Impedance Analysis (BIA) device
Measured: through study completion, an average of 1 year
Forced Expiratory Volume in 1 second (FEV1)
Measurement of FEV1 for the assessment of pulmonary function
Measured: through study completion, an average of 1 year
Forced Vital Capacity (FVC)
Measurement of FVC for the assessment of pulmonary function
Measured: through study completion, an average of 1 year
Diffusing Capacity of The Lungs for Carbon Monoxide (DLCO)
Measurement of DLCO for the assessment of pulmonary function.
Measured: through study completion, an average of 1 year
Total Lung Capacity (TLC)
Measurement of TLC for the assessment of pulmonary function.
Measured: through study completion, an average of 1 year
Respiratory Muscle Strength
Measurement of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) for assessment of respiratory muscle strength
Measured: through study completion, an average of 1 year
Six Minute Walk Test (6MWT)
Distance walked in six minutes (m)
Measured: through study completion, an average of 1 year
Gait speed
4-meter walking speed (m/s)
Measured: through study completion, an average of 1 year
St. George's Respiratory Questionnaire (SGRQ)
The questionnaire is designed to measure quality of life. It consists of symptom, activity, impact, and total scores. Each score ranges from 0 to 100. High scores indicate lower quality of life.
Measured: through study completion, an average of 1 year
Progressive Disease
Examination of all participants from clinical, physiological, and radiological perspectives
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Body Mass Index ( BMI)
kg/m2
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Dec 2022
- Primary completion1 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by Mersin 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Naycı, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178197
- Sponsor's protocol ID
- 2022/736
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 17 Sep 2025
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Sarcopenia With Quality of Life and Progression of Disease in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07178197
- Acronym / sponsor ID
- 2022/736
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF), Sarcopenia
- Keywords
- idiopathic pulmonary fibrosis, sarcopenia, skeletal muscle mass index, bioelectrical impedance analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Sep 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.
Sarcopenia negatively affects the prognosis of chronic diseases. However, the importance of sarcopenia in patients with idiopathic pulmonary fibrosis (IPF) has been less emphasized. The aim of the study is to determine the prevalence of sarcopenia in patients with IPF and to evaluate the impact of sarcopenia on quality of life and disease progression.
This study was designed as a descriptive cross-sectional. The study included patients diagnosed with IPF. Hand dynamometry and bioelectrical impedance analysis (BIA) were used to for diagnose of sarcopenia. Pulmonary function tests, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) measurements were examined. The 6-minute walk distance (6MWD) and 4-meter walking speed were recorded. The St. George Respiratory Questionnaire (SGRQ) was used to assess quality of life. All patients were evaluated for progressive disease.
Detailed description
The study was designed as a cross-sectional study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| idiopathic pulmonary fibrosis (IPF) | – | –The prevalence of sarcopenia was investigated in patients with IPF who met the inclusion and exclusion criteria. The relationship between sarcopenia and quality of life and disease progression in patients with IPF was evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the study were those diagnosed with IPF according to the ATS/ERS/JRS/ALAT 2022 guidelines and who applied to the Department of Pulmonary Diseases at Mersin University Faculty of Medicine.
Key inclusion criteria (3 listed)
- Being over 18 years of age
- Signing the informed consent form
- Having a diagnosis of IPF for at least one month
Key exclusion criteria (10 listed)
- Pregnancy
- History of cancer within the last 5 years
- History of lung surgery
- History of neuromuscular disease
- Active pulmonary tuberculosis
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
Hand Grip Strength
Time frame: through study completion, an average of 1 year
Hand Grip Strength (kg)- Grip strength measurement using a hand dynamometer
SMI (skeletal muscle mass index)
Time frame: through study completion, an average of 1 year
SMI (skeletal muscle mass index) (kg/m2) - SMI measurement using the Bioelectrical Impedance Analysis (BIA) device
Forced Expiratory Volume in 1 second (FEV1)
Time frame: through study completion, an average of 1 year
Measurement of FEV1 for the assessment of pulmonary function
Forced Vital Capacity (FVC)
Time frame: through study completion, an average of 1 year
Measurement of FVC for the assessment of pulmonary function
Diffusing Capacity of The Lungs for Carbon Monoxide (DLCO)
Time frame: through study completion, an average of 1 year
Measurement of DLCO for the assessment of pulmonary function.
Total Lung Capacity (TLC)
Time frame: through study completion, an average of 1 year
Measurement of TLC for the assessment of pulmonary function.
Respiratory Muscle Strength
Time frame: through study completion, an average of 1 year
Measurement of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) for assessment of respiratory muscle strength
Six Minute Walk Test (6MWT)
Time frame: through study completion, an average of 1 year
Distance walked in six minutes (m)
Gait speed
Time frame: through study completion, an average of 1 year
4-meter walking speed (m/s)
St. George's Respiratory Questionnaire (SGRQ)
Time frame: through study completion, an average of 1 year
The questionnaire is designed to measure quality of life. It consists of symptom, activity, impact, and total scores. Each score ranges from 0 to 100. High scores indicate lower quality of life.
Progressive Disease
Time frame: through study completion, an average of 1 year
Examination of all participants from clinical, physiological, and radiological perspectives
1 secondary outcome
Body Mass Index ( BMI)
Time frame: through study completion, an average of 1 year
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 17 Sep 2025.
- 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 Idiopathic Pulmonary Fibrosis (IPF) and Sarcopenia, run by Mersin 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 3 inclusion and 10 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 17 Sep 2025. 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?
Hand Grip Strength (time frame: through study completion, an average of 1 year). The study lists 11 primary outcomes in all. 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 17 Sep 2025.