COPDNCT06201403
Mechanical Properties of Peripheral and Accessory Respiratory Muscles in Chronic Obstructive Pulmonary Disease Patients
An observational study of COPD, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The biomechanical properties of accessory respiratory muscles and peripheral muscles of COPD and healthy subjects will be measured and compared with the MyotonPro device. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- Determination of biomechanical properties of muscles
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2024to 15 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Adult, Older adult
Study population: COPD and healthy adults
Who may be able to join
- Being diagnosed with group C and D COPD according to GOLD staging
- Having been using the same medications for the last 4 weeks
- No additional comorbid diseases of the orthopedic, neurological or cardiac system
- Being over 18 years of age
- Not having any diagnosed chronic disease
- Not being a smoker
Who cannot join
- Presence of another respiratory system disease other than COPD
- Patients who have had an acute COPD exacerbation in the last 4 weeks
- Patients experiencing COPD exacerbations during the study protocol
- Presence of fatty tissue at the measurement points, which may impair the measurement quality.
- Have already participated in another clinical trial within the last 30 days that may affect the results of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yedikule Chest Disease Hospital
Istanbul, Zeytinburnu, 34200
Esra Pehlivan, +902124090200, fztesrakambur@yahoo.com
About this study
The biomechanical properties of accessory respiratory muscles and peripheral muscles of COPD and healthy subjects will be measured and compared with the MyotonPro device.
- Conditions
- COPD
- Being tested
- Determination of biomechanical properties of muscles
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of biomechanical properties of musclesDiagnostic test
All evaluations will be performed with a MyotonPRO (Myoton AS., Tallinn, Estonia) digital palpation device. The data of the cases to be evaluated and the patterns related to the measurements will be transferred to the device by establishing a computer connection. Measurements will be performed unilaterally. The measurement point of the subjects' unilateral muscles will first be marked with a pencil. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement.
| Study group | Role | What they receive |
|---|---|---|
| COPD Group | Patients diagnosed with COPD at Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital Receives: Diagnostic Test: Determination of biomechanical properties of muscles | |
| Healthy Group | Healthy individuals without any chronic or acute disease Receives: Diagnostic Test: Determination of biomechanical properties of muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
M.Sternocleidomastoideus (SCM) myotonometric measurement
To measure the tension of the SCM, participants will be asked to lie supine on the bed. The evaluator will mark the central point with a pencil on the line connecting the mastoid process and the clavicle bone and then take the measurement. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
Measured: 107 millisecond
M. Trapezius myotonometric measurement
Participants will be instructed to sit comfortably in a chair with back support, lean their hips against the back of the chair, and keep their pelvis stationary with their feet on the floor and their hands in their lap. The shoulders will be in a neutral position, the knee and hip joints will be flexed to 90 degrees, and the trunk will remain upright. The measurement point of the upper trapezius is the midpoint of the connection between C7 and the acromion. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
Measured: 107 millisecond
M. Biceps brachii myotonometric measurement
While the participants are in a supine position, measurements will be taken from the middle between the lateral acromion and the medial border of the cubital fossa. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device vertically. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
Measured: 107 millisecond
M. Pectoralis Major (PM) myotonometric measurement
To measure the muscular characteristics of the PM, participants will be asked to lie in a supine position with their hips neutrally positioned and their knees fully extended. The measurement point of PM is the intersection of the vertical line from the midpoint of the clavicle and the horizontal line from the axilla. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
Measured: 107 millisecond
M. Rectus abdominis (RA) myotonometric measurement
Participants will lie in a supine position, with bilateral legs hip-knee flexed, feet supported on the bed. The muscle tone of the RA muscle portion will be measured from a point approximately 3 cm next to the belly button. The probe will be placed perpendicular to the surface and pressure will be applied until the probe turns green. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
Measured: 107 millisecond
M.Rectus femoris myotonometric measurement
While the participants are in the supine position, measurements will be taken from the midpoint between the SIPS and the top of the patella. The physiotherapist will hold the device upright and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
Measured: 107 millisecond
M.Vastus lateralis myotonometric measurement
While the participants are in the supine position, measurement will be taken from the midpoint of the line from the upper pole of the patella to the greater trochanter. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device vertically. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
Measured: 107 millisecond
M. Tibialis anterior myotonometric measurement
While the participants are in the supine position, measurements will be taken from the head of the fibula to the medial malleolus and 2 cm laterally from one-third of the tibia. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device upright. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
Measured: 107 millisecond
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start20 Jan 2024
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201403
- Sponsor's protocol ID
- COPD&Myoton
- Status last verified
- Apr 2025
- First submitted
- 30 Dec 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Properties of Peripheral and Accessory Respiratory Muscles in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT06201403
- Acronym / sponsor ID
- COPD&Myoton
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 11 Jan 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 biomechanical properties of accessory respiratory muscles and peripheral muscles of COPD and healthy subjects will be measured and compared with the MyotonPro device.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Group | – | Diagnostic Test: Determination of biomechanical properties of musclesPatients diagnosed with COPD at Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital |
| Healthy Group | – | Diagnostic Test: Determination of biomechanical properties of musclesHealthy individuals without any chronic or acute disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COPD and healthy adults
Key inclusion criteria (6 listed)
- Being diagnosed with group C and D COPD according to GOLD staging
- Having been using the same medications for the last 4 weeks
- No additional comorbid diseases of the orthopedic, neurological or cardiac system
- Being over 18 years of age
- Not having any diagnosed chronic disease
Key exclusion criteria (5 listed)
- Presence of another respiratory system disease other than COPD
- Patients who have had an acute COPD exacerbation in the last 4 weeks
- Patients experiencing COPD exacerbations during the study protocol
- Presence of fatty tissue at the measurement points, which may impair the measurement quality.
- Have already participated in another clinical trial within the last 30 days that may affect the results of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of biomechanical properties of musclesAll evaluations will be performed with a MyotonPRO (Myoton AS., Tallinn, Estonia) digital palpation device. The data of the cases to be evaluated and the patterns related to the measurements will be transferred to the device by establishing a computer connection. Measurements will be performed unilaterally. The measurement point of the subjects' unilateral muscles will first be marked with a pencil. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement. | Diagnostic test | COPD Group, Healthy Group |
Primary outcome
M.Sternocleidomastoideus (SCM) myotonometric measurement
Time frame: 107 millisecond
To measure the tension of the SCM, participants will be asked to lie supine on the bed. The evaluator will mark the central point with a pencil on the line connecting the mastoid process and the clavicle bone and then take the measurement. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
M. Trapezius myotonometric measurement
Time frame: 107 millisecond
Participants will be instructed to sit comfortably in a chair with back support, lean their hips against the back of the chair, and keep their pelvis stationary with their feet on the floor and their hands in their lap. The shoulders will be in a neutral position, the knee and hip joints will be flexed to 90 degrees, and the trunk will remain upright. The measurement point of the upper trapezius is the midpoint of the connection between C7 and the acromion. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
M. Biceps brachii myotonometric measurement
Time frame: 107 millisecond
While the participants are in a supine position, measurements will be taken from the middle between the lateral acromion and the medial border of the cubital fossa. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device vertically. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
M. Pectoralis Major (PM) myotonometric measurement
Time frame: 107 millisecond
To measure the muscular characteristics of the PM, participants will be asked to lie in a supine position with their hips neutrally positioned and their knees fully extended. The measurement point of PM is the intersection of the vertical line from the midpoint of the clavicle and the horizontal line from the axilla. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
M. Rectus abdominis (RA) myotonometric measurement
Time frame: 107 millisecond
Participants will lie in a supine position, with bilateral legs hip-knee flexed, feet supported on the bed. The muscle tone of the RA muscle portion will be measured from a point approximately 3 cm next to the belly button. The probe will be placed perpendicular to the surface and pressure will be applied until the probe turns green. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
M.Rectus femoris myotonometric measurement
Time frame: 107 millisecond
While the participants are in the supine position, measurements will be taken from the midpoint between the SIPS and the top of the patella. The physiotherapist will hold the device upright and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
M.Vastus lateralis myotonometric measurement
Time frame: 107 millisecond
While the participants are in the supine position, measurement will be taken from the midpoint of the line from the upper pole of the patella to the greater trochanter. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device vertically. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
M. Tibialis anterior myotonometric measurement
Time frame: 107 millisecond
While the participants are in the supine position, measurements will be taken from the head of the fibula to the medial malleolus and 2 cm laterally from one-third of the tibia. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device upright. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 COPD, run by Istanbul Medipol University Hospital 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 5 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: looking for participants now, as of the sponsor's last update on 1 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ESRA PEHLİVAN (09050585279, fztesrakambur@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M.Sternocleidomastoideus (SCM) myotonometric measurement (time frame: 107 millisecond). The study lists 8 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 1 May 2025.