Lung Diseases, ObstructiveNCT06306482
Determination of Posture in Patients With Restrictive and Obstructive Lung Disease
An observational study of Lung Diseases, Obstructive and Lung Diseases, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to determine posture and posture related factors in patients with restrictive and obstructive lung disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases, Obstructive, Lung Diseases, Postural; Defect
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 Mar 2024to 7 Mar 2026
- 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: Obstructive and restrictive lung disease and healthy controls will be included in this study according to the inclusion and exclusion criteria.
Who may be able to join
- Chronic Obstructive Pulmonary Disease Group Inclusion Criteria:
- Over 55 years old,
- Stage 1-2-3-4 according to the GOLD,
- Being clinically stable for the last 4 weeks.
- Chronic Obstructive Pulmonary Disease Group Exclusion Criteria:
- Receiving long-term oxygen therapy,
Show all 35Show fewer
- Having central and peripheral vestibular disease,
- Communication problems, known mental and cognitive problems,
- Having undergone any surgical intervention related to the spine within the last six months,
- Being diagnosed with CF as a result of two sweat tests,
- Being over 18 years old.
- Cystic Fibrosis Group Exclusion Criteria:
- Being in acute pulmonary exacerbation period,
- Receiving long-term oxygen therapy,
- Having undergone any surgical intervention related to the spine within the last six months,
- Diagnosed with asthma according to the Global Strategy for the Prevention and Treatment of Asthma (GINA),
- Clinically stable for the last 1 month
- Being over 18 years old.
- Asthma Group Exclusion Criteria:
- Change in medication for the last 1 month.
- Having undergone any surgical intervention related to the spine in the last six months,
- Being over 18 years old,
- Being diagnosed with bronchiectasis other than cystic fibrosis,
- Being clinically stable for the last 1 month.
- Bronchiectasis Group Exclusion Criteria:
- Receiving long-term oxygen therapy,
- Having undergone any surgical intervention related to the spine in the last six months.
- Diffuse Parenchymal Lung Diseases Inclusion Criteria:
- Being diagnosed with diffuse parenchymal lung according to American Thoracic Society/European Respiratory Society (ATS/ERS) criteria,
- Being over 18 years old,
- Having volunteered to participate in the research,
- To be clinically stable and to have comorbid conditions (such as hypertension, diabetes) under control,
- Diffuse Parenchymal Lung Diseases Exclusion Criteria:
- Having undergone any surgical intervention related to the spine within the last six months,
- Having exacerbation in the last 3 months
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aynur Demirel
Ankara, 06100
Hacettepe University
Ankara, 06100
Aynur Demirel, +905545295057 ext. 178, aynur.demirel@hacettepe.edu.tr
hidaye yamikan, +905349898724, hidaye.yamikan@hacettepe.edu.tr
About this study
Official title: Restriktif ve Obstrüktif Akciğer Hastalıklarında Postür ve Postürle İlişkili Faktörlerin Belirlenmesi
The aim of this study is to determine posture and posture related factors in patients with restrictive and obstructive lung disease.
Read the detailed description
It is aimed at investigating posture and posture related factors according to both type of disease and severity of disease in patients with restrictive and obstructive lung disease. The secondary purpose is to develop a model that determines correlations between posture and functional exercise capacity, respiratory and peripheral muscle strength, tightness of muscle, balance, and physical activity for each disease that will be included in this study. In accordance with these purposes, for each group, at least 15 patients with obstructive and restrictive lung disease will be included according to the inclusion and exclusion criteria for each disease, and 15 healthy controls will be included. Tests and questionnaires will be used in order to determine the severity of diseases. Lung function test and respiratory and peripheral muscle strength test will be performed. Time and Go test (TUG) and One minute sit to stand test will be performed. To evaluate the accessory respiratory muscles, a muscle tightness test will be performed for each muscle. Six Minute Walk Test (6 MWT) will be performed with an armband that measures energy expenditure for functional exercise capacity. To evaluate posture, the Corbin Postural Assessment Scale and photographic analysis will be used. Photographical analysis using software in lateral, posterior, and anterior views will be used for the cervical, thoracic, and lumbar regions. For angular and length measurements, anatomical landmarks will be determined and calculated in the regions. According to the results to be obtained, changes in posture according to the regions and posture related factors will be determined for each disease. It will guide professional working in this field.
- Conditions
- Lung Diseases, Obstructive, Lung Diseases, Postural; Defect
- Medical subject headings
- Lung Diseases, Obstructive, Lung Diseases
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 |
|---|---|---|
| Group A | Patients with chronic obstructive lung disease, asthma, cystic fibrosis and bronchiectasis. | |
| Group B | Patients with diffuse parenchymal lung diseases | |
| control group | healthy aged matched individuals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of horizontal alignment of the head anterior view
Angle between left and right tragus and horizontal will be measured via photographic analysis
Measured: 1 day
Evaluation of horizontal alignment of the trunk anterior view
Angle between left and right acromion and horizontal will be measured via photographic analysis Angle between left and right anterior superior iliac spine and horizontal will be measured via photographic analysis.
Angle between left and right acromion and left and right anterior superior iliac spine will be measured via photographic analysis.
Measured: 1 day
Evaluation of horizontal alignment of the head lateral view
Angle between left-right tragus and C7 spinous process and horizontal will be measured via photographic analysis.
Measured: 1 day
Evaluation of vertical alignment of the head lateral view
Angle of acromion and tragus (left-right) and vertical will be measured via photographic analysis.
Measured: 1 day
Evaluation of horizontal alignment of the trunk lateral view
Angle between anterior superior iliac spine and posterior superior iliac spina and horizontal will be measured via photographic analysis.
Measured: 1 day
Evaluation of vertical alignment of the trunk lateral view
Angle between acromion and greater trochanter and vertical will be measured via photographic analysis.
Measured: 1 day
Evaluation of horizontal asymmetry trunk in posterior view
Horizontal asymmetry of scapula in relation to T3 spinous process will be measured via photographic analysis.
Measured: 1 day
Evaluation of scapulae
Investigation of posture by photographic analysis upward rotation/ anterior tilt/internal rotation of scapula, scapular elevation, and scapular abduction evaluations will be measured photographic analysis.
Measured: 1 day
Posture
Posture will be examined via the Corbin Postural Assessment Scale. The total points of the Corbin Postural Assessment Scale range from 0 to 28 points. A higher point represents worse posture.
Measured: 1 day
Secondary outcomes (13)
Functional exercise capacity
Functional exercise capacity will be determined via Six Minute Walk Test.
Measured: 1 day
Respiratory Muscle Strength
Respiratory muscle strength will be assessed using a mouth pressure device according to American Thoracic Society/ European Respiratory Society guidelines.
Measured: 1 day
Lung function
Lung function will be assessed via a spirometer according to American Thoracic Society/ European Respiratory Society guidelines.
Measured: 1 day
Dyspnea
Dyspnea will be assessed via The Modified Medical Research Council. The Modified Medical Research Council consists of five grades. A higher grades represents severe dyspnea level.
Measured: 1 day
Peripheral muscle strength
Peripheral muscle strength will be assessed via hand dynamometer.
Measured: 1 day
Lower extremity capacity
One minute sit to stand test will be used for lower extremity capacity.
Measured: 1 day
Energy expenditure
An armband will be used to assess energy expenditure during six minute walk test.
Measured: 1 day
Balance and Fall risk
Time up and go test will be used to assess balance and fall risk
Measured: 1 day
Tightness of muscle
Pectoralis minör, pectoralis majör, adductor and internal rotator muscles, sternocleidomastoideus, and trapezius muscle tightness tests will be performed during musculoskeletal examination using a tape.
Measured: 1 day
Severity of disease for patients with COPD
Global Initiative for Chronic Obstructive Pulmonary Disease, Global Initiative for Chronic Obstructive Pulmonary A,B,E assessment Tool will be used for patients with COPD. According to the Global Initiative for Chronic Obstructive Pulmonary Disease, the severity of airflow limitation (Forced Expiratory Volume in 1 s) was determined as mild (≥ 80%), moderate (50-80%), severe (30-50%), and very severe (<30%). According to Global Initiative for Chronic Obstructive Pulmonary ABE assessment Tool, patients classified group A, B, and E using symptom status and airflow limitation.
Measured: 1 day
Severity of disease for patients with bronchiectasis
Patients with non- cystic fibrosis bronchiectasis will be classified into three groups according to the Forced Expiratory Volume in 1 s, Age, Chronic colonisation, Extension, Dyspnea level. According to this classification system, patients will be classified as 0-2 points mild, 3-4 moderate, 5-7 severe bronchiectasis.
Measured: 1 day
Diffusion capacity for patients with diffuse parenchymal lung diseases
Carbon Monoxide Diffusion Capacity test with single breath method will be used for patients with diffuse parenchymal lung diseases.
Measured: 1 day
Symptoms for patients with COPD
Chronic Obstructive Pulmonary Disease Assessment Test will be used to determined symptoms in patients with COPD. The total score of Chronic Obstructive Pulmonary Disease Assessment Test changes from 0 to 40 points, and 10 points is the accepted cut-off point for COPD.
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 posted12 Mar 2024
- Study start7 Mar 2024 (estimated)
- Primary completion7 Mar 2025 (estimated)
- Study completion7 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, ObstructiveStudies 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
- 90 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
- NCT06306482
- Sponsor's protocol ID
- SBA 23/390
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restriktif ve Obstrüktif Akciğer Hastalıklarında Postür ve Postürle İlişkili Faktörlerin Belirlenmesi
- ClinicalTrials.gov ID
- NCT06306482
- Acronym / sponsor ID
- SBA 23/390
- Conditions
- Lung Diseases, Obstructive, Lung Diseases, Postural; Defect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 7 Mar 2024 (estimated)
- Primary completion
- 7 Mar 2025 (estimated)
- Study completion
- 7 Mar 2026 (estimated)
- First posted
- 12 Mar 2024 (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 aim of this study is to determine posture and posture related factors in patients with restrictive and obstructive lung disease.
Detailed description
It is aimed at investigating posture and posture related factors according to both type of disease and severity of disease in patients with restrictive and obstructive lung disease. The secondary purpose is to develop a model that determines correlations between posture and functional exercise capacity, respiratory and peripheral muscle strength, tightness of muscle, balance, and physical activity for each disease that will be included in this study. In accordance with these purposes, for each group, at least 15 patients with obstructive and restrictive lung disease will be included according to the inclusion and exclusion criteria for each disease, and 15 healthy controls will be included. Tests and questionnaires will be used in order to determine the severity of diseases. Lung function test and respiratory and peripheral muscle strength test will be performed. Time and Go test (TUG) and One minute sit to stand test will be performed. To evaluate the accessory respiratory muscles, a muscle tightness test will be performed for each muscle. Six Minute Walk Test (6 MWT) will be performed with an armband that measures energy expenditure for functional exercise capacity. To evaluate posture, the Corbin Postural Assessment Scale and photographic analysis will be used. Photographical analysis using software in lateral, posterior, and anterior views will be used for the cervical, thoracic, and lumbar regions. For angular and length measurements, anatomical landmarks will be determined and calculated in the regions. According to the results to be obtained, changes in posture according to the regions and posture related factors will be determined for each disease. It will guide professional working in this field.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Patients with chronic obstructive lung disease, asthma, cystic fibrosis and bronchiectasis. |
| Group B | – | –Patients with diffuse parenchymal lung diseases |
| control group | – | –healthy aged matched individuals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obstructive and restrictive lung disease and healthy controls will be included in this study according to the inclusion and exclusion criteria.
Key inclusion criteria (35 listed)
- Over 55 years old,
- Stage 1-2-3-4 according to the GOLD,
- Being clinically stable for the last 4 weeks.
- Receiving long-term oxygen therapy,
- Having central and peripheral vestibular disease,
Key exclusion criteria (0 listed)
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
Evaluation of horizontal alignment of the head anterior view
Time frame: 1 day
Angle between left and right tragus and horizontal will be measured via photographic analysis
Evaluation of horizontal alignment of the trunk anterior view
Time frame: 1 day
Angle between left and right acromion and horizontal will be measured via photographic analysis Angle between left and right anterior superior iliac spine and horizontal will be measured via photographic analysis. Angle between left and right acromion and left and right anterior superior iliac spine will be measured via photographic analysis.
Evaluation of horizontal alignment of the head lateral view
Time frame: 1 day
Angle between left-right tragus and C7 spinous process and horizontal will be measured via photographic analysis.
Evaluation of vertical alignment of the head lateral view
Time frame: 1 day
Angle of acromion and tragus (left-right) and vertical will be measured via photographic analysis.
Evaluation of horizontal alignment of the trunk lateral view
Time frame: 1 day
Angle between anterior superior iliac spine and posterior superior iliac spina and horizontal will be measured via photographic analysis.
Evaluation of vertical alignment of the trunk lateral view
Time frame: 1 day
Angle between acromion and greater trochanter and vertical will be measured via photographic analysis.
Evaluation of horizontal asymmetry trunk in posterior view
Time frame: 1 day
Horizontal asymmetry of scapula in relation to T3 spinous process will be measured via photographic analysis.
Evaluation of scapulae
Time frame: 1 day
Investigation of posture by photographic analysis upward rotation/ anterior tilt/internal rotation of scapula, scapular elevation, and scapular abduction evaluations will be measured photographic analysis.
Posture
Time frame: 1 day
Posture will be examined via the Corbin Postural Assessment Scale. The total points of the Corbin Postural Assessment Scale range from 0 to 28 points. A higher point represents worse posture.
13 secondary outcomes
Functional exercise capacity
Time frame: 1 day
Respiratory Muscle Strength
Time frame: 1 day
Lung function
Time frame: 1 day
Dyspnea
Time frame: 1 day
Peripheral muscle strength
Time frame: 1 day
Lower extremity capacity
Time frame: 1 day
Energy expenditure
Time frame: 1 day
Balance and Fall risk
Time frame: 1 day
Tightness of muscle
Time frame: 1 day
Severity of disease for patients with COPD
Time frame: 1 day
Severity of disease for patients with bronchiectasis
Time frame: 1 day
Diffusion capacity for patients with diffuse parenchymal lung diseases
Time frame: 1 day
Symptoms for patients with COPD
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 12 Mar 2024.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, Obstructive and Lung Diseases, run by Hacettepe University at 2 sites 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 35 inclusion and 0 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (+905545295057, 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?
Evaluation of horizontal alignment of the head anterior view (time frame: 1 day). The study lists 9 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 12 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.