Chronic Obstructive Pulmonary DiseaseNCT06246370
An Investigation of the Cervical Region Biomechanics in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Postural; Defect, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate cervical region biomechanics, muscle performance and respiratory muscle strength in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy subjects. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Postural; Defect, Cervical Pain
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2024to 6 Sep 2025
- 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 40 years and older
- 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 stage 1-2-3-4 according to the Classification of Airflow Limitation in COPD (GOLD) system,
- Being >40 years old,
- Being cognitively competent to understand and answer evaluation questions.
- Being clinically stable for the last 4 weeks,
- Being under control of accompanying comorbid conditions (such as hypertension, diabetes),
- Volunteering to participate in the research.
Who cannot join
- • Having been hospitalized due to exacerbation in the last 3 months,
- Having a musculoskeletal, neurological, rheumatological or oncological disease that affects the craniocervical \& cervicothoracic joints and/or may prevent evaluation,
- Having undergone any surgical intervention on the craniocervicofacial region and spine in the last six months,
- Having lung malignancy, neoplasm, adenocarcinoma,
- Being a lung cancer patient or having received cancer treatment (head and neck lung radiotherapy), having undergone pneumonectemia, lobectomy or resection surgery,
- Being treated for anxiety and depression,
Show all 10Show fewer
- Having scoliosis,
- Having a congenital anomaly of the craniocervicofacial region.
- Having 3 out of 4 findings according to the diagnostic criteria for cervical radiculopathy,
- Having thoracic outlet syndrome (TOS)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Health Sciences Faculty
Ankara, 06100
Aynur demirel, PhD, +903052525 ext. 168, aynur.demirel@hacettepe.edu.tr
irem seleoglu
About this study
Official title: Kronik Obstruktif Akciğer Hastalığında Servikal bölge Biyomekaniği, Kas Performansı ve Solunum Kas Kuvvetinin İncelenmesi
The aim of this study is to investigate cervical region biomechanics, muscle performance and respiratory muscle strength in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy subjects.
Read the detailed description
The secondary purposes are to investigate the correlation between cervical region biomechanics and posture, functional exercise capacity, depression \&anxiety level,neck disability, cough severity. In accordance with this purposes, 17 patients with COPD who have Global Initiative for Chronic Obstruction Lung Disease (GOLD) stage 1-2-3-4, being clinically stable for 4 weeks and 17 healthy controls will be included ages>40. Tests and questionnaires will be used in order to determine the severity of COPD and to evaluate posture. Photographical analysis in lateral and posterior views will be used for evaluation of cranioservical region static and dynamic biomechanics. To analyze of chest wall, radiographic evaluation will be performed. Goniometry will be used for evaluation dynamic craniocervical kinematic analysis. Cranioservical region muscle strength and endurance tests will be performed. Respiratory muscle strength tests and cough evaluation test will be performed. Neck disability index, cough evaluation test questionnare, beck depression and anxiety questionnares, Nordic Musculoskeletal questionnare will be used. 6 Minute Pegboard and Ring Test, 6 Minute Walk Test will be performed. According to the results to be obtained, relationship between cranioservical region biomechanics and posture will be investigated based on the severity of disease in patients with COPD. It will guide professional working in the field.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Neck Pain, Cough
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 |
|---|---|---|
| COPD group | patients with COPD aged 40 years and above. | |
| control group | aged matced healty patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sagittal cobb angle
Cobb anle will measure from X-ray imagination between T2- T12 level.
Measured: day 1
Cranial rotation angle
Tragus- eye horizontal angle will measure from lateral cervical photographs.
Measured: day 1
evaluation of cervical region biomechanic (dynamic)
Investigation of the cervical region range of motions of cervical flexion, cervical extension, cervical lateral flexion, and cervical rotation range of motion.
Measured: day 1
cervical inclination angle
tragus eye and C7 level horizontal angle will measure from lateral cervical photographs.
Measured: day 1
cervical lateral flexion angle
the angle between pogonion-tragus and C7 level will measure from lateral cervical photographs.
Measured: day 1
Shoulder elevation/depression angle
the angle between acromion- C7 level and horizontal line will measure from lateral cervical photographs.
Measured: day 1
chest wall analysis
the distance between 3rd, 7th and 9th ribs and horizontal line will measure from X-Ray
Measured: day 1
rib angle
Sternum and 4th,5th, 6th rib will mark and the angle between these and maximum anteroposteror dimention of the thorax will measure from X-Ray.
Measured: day 1
diaphragma height
the distance between T1- and L2 level will measure from X-Ray.
Measured: day 1
Secondary outcomes (15)
postural analysis
investigation of posture by photographic analysis in patients with COPD upward rotation/ anterior tilt/internal rotation of scapula, scapular elevation, and scapular abduction evaluations will measure from photographic analysis.
Measured: day 1
respiratory muscle strength
respiratory muscle strength by mouth pressure device, mean inspiratory pressure and mean expiratory pressure will be tested.
Measured: day 1
cervical region muscle strength and endurance
investigation of cervical region muscle strength and endurance with stabilizer biofeedback pressure method
Measured: day 1
airway flow limitation
severity of disease by Global İnitiative for Chronic Obstructive Pulmonary Disease scale, GOLD 1: FEV1 (predicted%) ≥%80 GOLD 2: %50 ≤ FEV1 (predicted% ) < %79 GOLD 3: %30 ≤ FEV1 (predicted%) < %49 GOLD 4 : FEV1 (predicted%) < %30
Measured: day 1
management of cough
cough severity will be tested by the Cough evaluation Test.(1-5 scaling of items, 5-25 score range) The minimal important difference was 2.
Measured: day 1
Upper Extremity Functional Capacity
evaluation of upper extremity functional capacity with 6-minute pegboard ring test
Measured: day 1
functional exercise capacity
functional exercise capacity by 6 minute walking test.
Measured: day 1
anxiety level
investigation of anxiety level with the Beck Anxiety Questionnaire (A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe)
Measured: day 1
general musculoskeletal pain level
general musculoskeletal pain level is evaluated by Nordic Musculoskeletal Questionnare, cut off point is 'one yes answer'
Measured: day 1
evaluation of cervical radiculopathy
- Spurling test
- cervical distraction test
- cervical rotation test (if + spurling and cervical distraction test side is same with this test and is lower than 60 degree)
- upper extremity stretching test
If there are 3 positive answer to 4 tests, cervical radiculopathy existence will be detected.
Measured: day 1
investigation of neck disability severity
evaluation of neck disability level by neck disability index,10-point change should be used as the minimum clinically important difference for patients with upper extremity referred sypmtoms
Measured: day 1
investigation of the disease severity
evaluation of the disease severity with chronic obstructive pulmonary disease severity with Chronic Respiratory Questionnaire MCID( minimal clinically important difference) = a change of 0.5 per item A change in the score of 0.5 on the 7 point scale reflects a clinically significant small change
A change of 1.0 reflects a moderate change
A difference of 1.5 represents a large change
Measured: day 1
investigation of the Pulmonary Function
evaluation of pulmonary functions with Lung function test FEV %,FEV1 %, FVC %, FEV1/FVC % , FEF 25-75%, PEF %
Measured: day 1
cough sufficiency in patients with COPD
evaluation of cough sufficiency with peak expiratory flow meter device, A peak expiratory flow of < 80% predicted was the best cut-off to detect airflow limitation.
Measured: day 1
depression level
investigation of depression level with Beck Depression Inventory (cut off point is 17 point) Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.
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 posted7 Feb 2024
- Study start20 Feb 2024 (estimated)
- Primary completion6 Sep 2024 (estimated)
- Study completion6 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary 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
- 34 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
- NCT06246370
- Sponsor's protocol ID
- GO 23/616
- Status last verified
- Jan 2024
- First submitted
- 11 Oct 2023
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kronik Obstruktif Akciğer Hastalığında Servikal bölge Biyomekaniği, Kas Performansı ve Solunum Kas Kuvvetinin İncelenmesi
- ClinicalTrials.gov ID
- NCT06246370
- Acronym / sponsor ID
- GO 23/616
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (estimated)
- Primary completion
- 6 Sep 2024 (estimated)
- Study completion
- 6 Sep 2025 (estimated)
- First posted
- 7 Feb 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 investigate cervical region biomechanics, muscle performance and respiratory muscle strength in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy subjects.
Detailed description
The secondary purposes are to investigate the correlation between cervical region biomechanics and posture, functional exercise capacity, depression \&anxiety level,neck disability, cough severity. In accordance with this purposes, 17 patients with COPD who have Global Initiative for Chronic Obstruction Lung Disease (GOLD) stage 1-2-3-4, being clinically stable for 4 weeks and 17 healthy controls will be included ages>40. Tests and questionnaires will be used in order to determine the severity of COPD and to evaluate posture. Photographical analysis in lateral and posterior views will be used for evaluation of cranioservical region static and dynamic biomechanics. To analyze of chest wall, radiographic evaluation will be performed. Goniometry will be used for evaluation dynamic craniocervical kinematic analysis. Cranioservical region muscle strength and endurance tests will be performed. Respiratory muscle strength tests and cough evaluation test will be performed. Neck disability index, cough evaluation test questionnare, beck depression and anxiety questionnares, Nordic Musculoskeletal questionnare will be used. 6 Minute Pegboard and Ring Test, 6 Minute Walk Test will be performed. According to the results to be obtained, relationship between cranioservical region biomechanics and posture will be investigated based on the severity of disease in patients with COPD. It will guide professional working in the field.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD group | – | –patients with COPD aged 40 years and above. |
| control group | – | –aged matced healty patients |
Who may qualify
- Ages
- 40 years and older
- 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 stage 1-2-3-4 according to the Classification of Airflow Limitation in COPD (GOLD) system,
Key exclusion criteria (10 listed)
- • Having been hospitalized due to exacerbation in the last 3 months,
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 sagittal cobb angle
Time frame: day 1
Cobb anle will measure from X-ray imagination between T2- T12 level.
Cranial rotation angle
Time frame: day 1
Tragus- eye horizontal angle will measure from lateral cervical photographs.
evaluation of cervical region biomechanic (dynamic)
Time frame: day 1
Investigation of the cervical region range of motions of cervical flexion, cervical extension, cervical lateral flexion, and cervical rotation range of motion.
cervical inclination angle
Time frame: day 1
tragus eye and C7 level horizontal angle will measure from lateral cervical photographs.
cervical lateral flexion angle
Time frame: day 1
the angle between pogonion-tragus and C7 level will measure from lateral cervical photographs.
Shoulder elevation/depression angle
Time frame: day 1
the angle between acromion- C7 level and horizontal line will measure from lateral cervical photographs.
chest wall analysis
Time frame: day 1
the distance between 3rd, 7th and 9th ribs and horizontal line will measure from X-Ray
rib angle
Time frame: day 1
Sternum and 4th,5th, 6th rib will mark and the angle between these and maximum anteroposteror dimention of the thorax will measure from X-Ray.
diaphragma height
Time frame: day 1
the distance between T1- and L2 level will measure from X-Ray.
15 secondary outcomes
postural analysis
Time frame: day 1
respiratory muscle strength
Time frame: day 1
cervical region muscle strength and endurance
Time frame: day 1
airway flow limitation
Time frame: day 1
management of cough
Time frame: day 1
Upper Extremity Functional Capacity
Time frame: day 1
functional exercise capacity
Time frame: day 1
anxiety level
Time frame: day 1
general musculoskeletal pain level
Time frame: day 1
evaluation of cervical radiculopathy
Time frame: day 1
investigation of neck disability severity
Time frame: day 1
investigation of the disease severity
Time frame: day 1
investigation of the Pulmonary Function
Time frame: day 1
cough sufficiency in patients with COPD
Time frame: day 1
depression level
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 7 Feb 2024.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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 Chronic Obstructive Pulmonary Disease 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 6 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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 (+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?
Evaluation of sagittal cobb angle (time frame: day 1). 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 7 Feb 2024.