Diffuse Parenchymal Lung DiseaseNCT06171425
Evaluation of Patients With Diffuse Parenchymal Lung Diseases Regarding Frailty
An observational study of Diffuse Parenchymal Lung Disease and Frailty, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
There are very few studies in the literature examining the frailty levels of diffuse parenchymal lung disease (DPLD) patients and its effect on their functional status despite the high prevalance of frailty in patients with DPLD This observational study aims to learn about the relationship between frailty and… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diffuse Parenchymal Lung Disease, Frailty, Physical Inactivity
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2023to 22 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients referred by the department of chest diseases of Hacettepe university will be taken
Who may be able to join
- Being diagnosed with Diffuse parenchymal lung according to the American Thoracic Society/European Respiratory Society (ATS/ERS) criteria,
- Being between the ages of 30-65,
- Being literate,
- Being willing to participate in the research,
- Being clinically stable and having any accompanying comorbid conditions (such as hypertension, diabetes) under control,
- Not having any orthopedic, metabolic or neurological problems that may prevent evaluation of peripheral muscle strength, balance and exercise capacity.
Who cannot join
- Having recently experienced syncope,
- Having a history of unstable cardiovascular disease,
- Having been hospitalized due to exacerbation in the last 3 months,
- Having received pulmonary rehabilitation in the last 12 months,
- Having a neurological disease,
- Being dependent and using a walking aid while performing the person's daily life activities,
- Having a pacemaker,
- Having a diagnosis of lung cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Health Sciences Faculty
Ankara, 06100
About this study
Official title: Diffüz Parankimal Akciğer Hastalarında Kırılganlık Düzeyi, Egzersiz Kapasitesi ve Denge Değerlendirilmesi
There are very few studies in the literature examining the frailty levels of diffuse parenchymal lung disease (DPLD) patients and its effect on their functional status despite the high prevalance of frailty in patients with DPLD This observational study aims to learn about the relationship between frailty and functional capacity and balance in DPLD patients compared to healthy subjects.
Read the detailed description
The aim of the study is to evaluate the relationship between the level of frailty and exercise capacity, respiratory functions, diffusion capacity, balance level, postural changes, activities of daily living, peripheral muscle strength and quality of life parameters in DPLD patients. The second aim is to compare diffuse parenchymal lung patients and the healthy control group in terms of these parameters.
- Medical subject headings
- Lung Diseases, Interstitial, Frailty, 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 |
|---|---|---|
| DPAH group | patients with diffuse parenchymal lung diseases | |
| control group | aged matched healthy patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
frailty level
evaluation of frailty level with Fried Frailty Criteria which are weight loss existence, muscle strength, physical activity (will be measured with International Physical Activity Questionnaire), mobility (will be measured by 4-meter walking test), and depression level. Fried frailty phenotype consists of five criteria: loss, exhaustion, physical inactivity, low hand grip strength, and slow walking speed. Patients who have three or more of these criteria are defined as frail, those who have one or two criteria, are defined as prefrail, and none of the criteria are defined as robust.
Measured: 1 time which will be in one day
Secondary outcomes (11)
comorbidity assesment
via Charlson comorbidity index (values between 0-33)
Measured: 1 time which will be in one day
exercise capacity
by 1 minute sit to stand test
Measured: 1 time which will be in one day
balance measurement
by timed up and go test
Measured: day 1
posture analysis
corbin postural assesment scale from lateral and posterior view will be applied. The Corbin Posture Scale is a postural assessment scale that evaluates the inclination of the head in different directions, the shape of the dorsal region, the presence of scapulaand shoulder protraction, the signs of scoliosis, kyphosis, lordosis, whether there is a difference in the height of the two shoulders and hips, the sagging status in the abdominal region, the presence of gibbosity, genu recurvatum, and the level of anterior balance by assigning a score between 0-3.
Measured: day 1
posture related conditions measurement
observational analysis by scapular dyskinesia test
Measured: day 1
posture related (scapular motion)conditions existence measurement
by lateral scapular slide test which evaluates distance between medial border of spine scapulae and T3 spinous process- T7 spinous process and inferior angle of scapulae
Measured: day 1
quality of life evaluation
Quality of life will be assessed by Saint George respiratory questionnaire. A total score is calculated from 0 (no health impairment) to 100 (maximum health impairment).
Measured: day 1
evaluation of participation to daily life activities
Participation to daily life activities will be evaluated by London Chest Activities of Daily Living Questionnare. Contains 15 items grouped into four domains: self-care, household activities (domestic), physical, and leisure activities. Responses for each item range from 0-5, with 0 indicating "wouldn't do anyway", 1-4 representing degree of breathlessness and 5 representing the greatest difficulty with performing ADL (someone else completes). Responses to items 1-15 are added; the total score can range from 0 to 75 points, with higher scores indicating greater functional limitation
Measured: day 1
pulmonary function measurement
evaluation of pulmonary function with lung function test which will be detected via FVC, FEV1, FEV1/FVC, PEF, FEF25-75% At least three technically acceptable measurements were obtained between the two best-measured FEV1 values, with no more than a 5% difference, and the best FEV1 value was selected for analysis.
Measured: day 1
investigation of diffusion capacity of the lung
by diffusion capacity of carbon monoxide of lung with single breath method
Measured: day 1
peripheral muscle strength
by hand held dynamometry device
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start25 Dec 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion22 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Parenchymal Lung DiseaseStudies 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Demirel, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171425
- Sponsor's protocol ID
- GO 23/18
- Status last verified
- Dec 2023
- First submitted
- 30 Oct 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffüz Parankimal Akciğer Hastalarında Kırılganlık Düzeyi, Egzersiz Kapasitesi ve Denge Değerlendirilmesi
- ClinicalTrials.gov ID
- NCT06171425
- Acronym / sponsor ID
- GO 23/18
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Dec 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 22 Feb 2024 (estimated)
- First posted
- 14 Dec 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.
There are very few studies in the literature examining the frailty levels of diffuse parenchymal lung disease (DPLD) patients and its effect on their functional status despite the high prevalance of frailty in patients with DPLD This observational study aims to learn about the relationship between frailty and functional capacity and balance in DPLD patients compared to healthy subjects.
Detailed description
The aim of the study is to evaluate the relationship between the level of frailty and exercise capacity, respiratory functions, diffusion capacity, balance level, postural changes, activities of daily living, peripheral muscle strength and quality of life parameters in DPLD patients. The second aim is to compare diffuse parenchymal lung patients and the healthy control group in terms of these parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPAH group | – | –patients with diffuse parenchymal lung diseases |
| control group | – | –aged matched healthy patients |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred by the department of chest diseases of Hacettepe university will be taken
Key inclusion criteria (6 listed)
- Being diagnosed with Diffuse parenchymal lung according to the American Thoracic Society/European Respiratory Society (ATS/ERS) criteria,
- Being between the ages of 30-65,
- Being literate,
- Being willing to participate in the research,
- Being clinically stable and having any accompanying comorbid conditions (such as hypertension, diabetes) under control,
Key exclusion criteria (8 listed)
- Having recently experienced syncope,
- Having a history of unstable cardiovascular disease,
- Having been hospitalized due to exacerbation in the last 3 months,
- Having received pulmonary rehabilitation in the last 12 months,
- Having a neurological disease,
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
frailty level
Time frame: 1 time which will be in one day
evaluation of frailty level with Fried Frailty Criteria which are weight loss existence, muscle strength, physical activity (will be measured with International Physical Activity Questionnaire), mobility (will be measured by 4-meter walking test), and depression level. Fried frailty phenotype consists of five criteria: loss, exhaustion, physical inactivity, low hand grip strength, and slow walking speed. Patients who have three or more of these criteria are defined as frail, those who have one or two criteria, are defined as prefrail, and none of the criteria are defined as robust.
11 secondary outcomes
comorbidity assesment
Time frame: 1 time which will be in one day
exercise capacity
Time frame: 1 time which will be in one day
balance measurement
Time frame: day 1
posture analysis
Time frame: day 1
posture related conditions measurement
Time frame: day 1
posture related (scapular motion)conditions existence measurement
Time frame: day 1
quality of life evaluation
Time frame: day 1
evaluation of participation to daily life activities
Time frame: day 1
pulmonary function measurement
Time frame: day 1
investigation of diffusion capacity of the lung
Time frame: day 1
peripheral muscle strength
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
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 Diffuse Parenchymal Lung Disease and Frailty, 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 6 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: status not confirmed, as of the sponsor's last update on 19 Dec 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, Assoc. Prof. (+9053123051576 ext. 178, aynur.demirel@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frailty level (time frame: 1 time which will be in one 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 19 Dec 2023.