CopdNCT06410950
Mechanical Muscle Proprieties in Patient with COPD
An observational study of Copd and Muscle Weakness, run by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara at 1 site in Romania.
Trial summary
This study aims to determine if patients with Chronic Obstructive Pulmonary Disease (COPD) exhibit altered muscle properties (specifically changes in tone and stiffness) in both their respiratory muscles and skeletal muscles when compared to healthy individuals. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Copd, Muscle Weakness, Muscle Weakness Condition
- What is being tested?
- MyotonPRO Assessment of Muscle Biomechanical Properties
- How many people
- 87 participants
- Where
- 1 siteRomania
- Study dates
- 13 May 2024to 9 Jan 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with COPD and healthy subjects
Who may be able to join
- Diagnosis of COPD: Confirmed diagnosis of COPD based on GOLD spirometry criteria:
- Post-bronchodilator FEV1/FVC ratio < 0.70 Documented history of respiratory symptoms (e.g., dyspnea, cough, sputum production) Stable COPD: No COPD exacerbations requiring hospitalization in the past 6 months.
- Smoking History: Current or former smoker with a documented smoking history of at least 10 pack-years (cumulative cigarette consumption).
- Age: 45-75 years old. Ability to Understand and Follow Instructions: Mentally competent and able to understand the study procedures, risks, and benefits, providing written informed consent.
- No History of Respiratory Disease: free from any current or past respiratory diagnoses, including asthma, chronic bronchitis, or recurrent respiratory infections.
- Normal lung function: spirometry testing will confirm normal lung function with a post-bronchodilator FEV1/FVC ratio > 0.70 and no evidence of airflow obstruction.
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- No significant chronic conditions: free from any major chronic medical conditions that could impact muscle function or confound the results (e.g., uncontrolled diabetes, heart failure, advanced liver disease).
- Age: 45-75 years old Ability to understand and follow instructions: mentally competent and able to understand the study procedures, risks, and benefits, providing written informed consent.
- No recent infections: free from any recent respiratory or other infections within the past 4 weeks.
- Non-smoker or minimal smoking history: non-smokers or have a very minimal smoking history (less than 10 pack-years)
Who cannot join
- Other respiratory disease than COPD. Severe COPD exacerbation: anyone with a COPD exacerbation requiring hospitalization within the last six months.
- Conditions limiting chest wall movement: severe kyphosis, ankylosing spondylitis, or similar conditions that significantly impact the ability to expand the chest wall and perform respiratory muscle assessments.
- Muscular or neuromuscular disorders: primary muscular diseases (e.g., muscular dystrophy) or neuromuscular disorders affecting muscle function (e.g., Parkinson's, multiple sclerosis).
- Recent Surgery or Trauma: Significant surgery or trauma within the past three months that might affect muscle function or the ability to perform assessments.
- Uncontrolled comorbidities: severe, uncontrolled medical conditions that could significantly impact muscle function or confound the study results (e.g., uncontrolled heart failure, advanced renal disease).
- Recent respiratory infection: anyone with a current respiratory tract infection (viral or bacterial) within the past four weeks.
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- Mild respiratory symptoms: Even mild, persistent respiratory symptoms (chronic cough, sputum production) within the past 4 weeks.
- Conditions limiting chest wall movement: severe kyphosis, ankylosing spondylitis, or similar conditions that significantly impact the ability to expand the chest wall and perform respiratory muscle assessments.
- Muscular or neuromuscular disorders: primary muscular diseases (e.g., muscular dystrophy) or neuromuscular disorders affecting muscle function (e.g., Parkinson's, multiple sclerosis).
- Recent Surgery or Trauma: Significant surgery or trauma within the past three months that might affect muscle function or the ability to perform assessments.
- Uncontrolled comorbidities: severe, uncontrolled medical conditions that could significantly impact muscle function or confound the study results (e.g., uncontrolled heart failure, advanced renal disease).
Trial locations and contacts
1 site in 1 country.
Romania1 site
Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes
Timișoara, Timiș County, 300301
About this study
Official title: Exploring Muscle Proprieties in COPD: a Non-invasive Evaluation of Respiratory and Limb Muscle Mechanics Using Myotonometry.
This study aims to determine if patients with Chronic Obstructive Pulmonary Disease (COPD) exhibit altered muscle properties (specifically changes in tone and stiffness) in both their respiratory muscles and skeletal muscles when compared to healthy individuals. The study will utilize the Myotonometer, a non-invasive device, to assess these properties.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) leads to progressive airflow limitation and respiratory muscle dysfunction, contributing to exercise intolerance and reduced quality of life. While existing methods evaluate overall lung function, the assessment of specific respiratory muscle properties remains challenging. Myotonometry offers a non-invasive technique to quantify muscle tone and stiffness, potentially providing insights into respiratory and skeletal muscle mechanics in COPD. This study aims to explore differences in the mechanical properties of both superficial respiratory and skeletal muscles in patients with COPD compared to healthy controls using myotonometry. Investigators hypothesize that COPD patients will exhibit altered mechanical properties (e.g., increased stiffness and tone) in both superficial respiratory and skeletal muscles compared to healthy controls.
- Conditions
- Copd, Muscle Weakness, Muscle Weakness Condition
- Being tested
- MyotonPRO Assessment of Muscle Biomechanical Properties
- Keywords
- COPD, Muscle tone, Muscle stiffness, Muscle mechanical proprieties
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyotonPRO Assessment of Muscle Biomechanical PropertiesDiagnostic test
Muscle assessments will be conducted using the MyotonPRO (Myoton AS., Tallinn, Estonia) digital palpation device. Measurement patterns and subject data will be uploaded to the device via computer. Each evaluation will be performed bilaterally.
Subjects' muscle measurement points will be marked prior to assessment. The physiotherapist will position the device perpendicular to the muscle body and apply downward pressure (18N). Pressure should be maintained until the device's probe light changes from red to green. Five measurement pulses will then be applied. Each pulse lasts 15 ms with an 8 ms interval between pulses.
The SENIAM sensor location guide will be used to determine the approximate motor point for MyotonPRO measurements.
| Study group | Role | What they receive |
|---|---|---|
| COPD subjects | Individuals diagnosed with COPD based on GOLD spirometry criteria (post-bronchodilator FEV1/FVC ratio < 0.70).
Stable COPD with no exacerbations requiring hospitalization in the past six months.
Age range: 45-75 years old. Receives: Diagnostic Test: MyotonPRO Assessment of Muscle Biomechanical Properties | |
| Healthy subjects | Individuals with no history of chronic respiratory disease or recent infections.
Normal lung function on spirometry (post-bronchodilator FEV1/FVC ratio > 0.70). Age range: 40-75 years old. Receives: Diagnostic Test: MyotonPRO Assessment of Muscle Biomechanical Properties |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semispinalis capitis state of tension
To assess the tension of the semispinalis capitis (SC), participants will lie in a supine position on the treatment table. The physiotherapist will identify the measurement point using a pencil. This point will be located approximately two finger widths lateral to the spinous process of the C7 vertebra and slightly inferior to the occiput (base of the skull). The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Measured: Baseline
Semispinalis capitis biomechanical properties
To assess the biomechanical properties of the semispinalis capitis (SC), participants will lie in a supine position on the treatment table. The physiotherapist will identify the measurement point using a pencil. This point will be located approximately two finger widths lateral to the spinous process of the C7 vertebra and slightly inferior to the occiput (base of the skull). The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
Biomechanical properties: S-Dynamic Stiffness [N/m].
Measured: Baseline
Semispinalis capitis viscoelastic properties
To assess the viscoelastic properties of the semispinalis capitis (SC), participants will lie in a supine position on the treatment table. The physiotherapist will identify the measurement point using a pencil. This point will be located approximately two finger widths lateral to the spinous process of the C7 vertebra and slightly inferior to the occiput (base of the skull). The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Measured: Baseline
Sternocleidomastoideus (SCM) state of tension
To assess the tension of the sternocleidomastoideus (SCM), participants will lie supine on the treatment table. The evaluator will locate the midpoint on a line between the mastoid process (behind the ear) and the clavicle (collarbone), marking this point with a pencil. The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Measured: Baseline
Sternocleidomastoideus (SCM) biomechanical properties
To assess the biomechanical properties of the sternocleidomastoideus (SCM), participants will lie supine on the treatment table. The evaluator will locate the midpoint on a line between the mastoid process (behind the ear) and the clavicle (collarbone), marking this point with a pencil. The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
Biomechanical properties: S-Dynamic Stiffness [N/m].
Measured: Baseline
Sternocleidomastoideus (SCM) viscoelastic properties
To assess the viscoelastic properties of the sternocleidomastoideus (SCM), participants will lie supine on the treatment table. The evaluator will locate the midpoint on a line between the mastoid process (behind the ear) and the clavicle (collarbone), marking this point with a pencil. The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Measured: Baseline
Trapezius state of tension
To assess the tension of the trapezius, participants will sit upright in a chair with good back support. Their hips should touch the back of the chair, feet flat on the floor, and hands resting comfortably in their lap. Shoulders will be relaxed, and knees and hips bent at a 90-degree angle. The upper trapezius measurement point is midway between the C7 vertebra (prominent at the base of the neck) and the acromion (the bony tip of the shoulder). The following will be assessed:
Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Measured: Baseline
Trapezius biomechanical properties
To assess the biomechanical properties of the trapezius, participants will sit upright in a chair with good back support. Their hips should touch the back of the chair, feet flat on the floor, and hands resting comfortably in their lap. Shoulders will be relaxed, and knees and hips bent at a 90-degree angle. The upper trapezius measurement point is midway between the C7 vertebra (prominent at the base of the neck) and the acromion (the bony tip of the shoulder). The following will be assessed:
Biomechanical properties: S-Dynamic Stiffness [N/m].
Measured: Baseline
Trapezius viscoelastic properties
To assess the viscoelastic properties of the trapezius, participants will sit upright in a chair with good back support. Their hips should touch the back of the chair, feet flat on the floor, and hands resting comfortably in their lap. Shoulders will be relaxed, and knees and hips bent at a 90-degree angle. The upper trapezius measurement point is midway between the C7 vertebra (prominent at the base of the neck) and the acromion (the bony tip of the shoulder). The following will be assessed:
Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Measured: Baseline
Deltoid state of tension
To assess deltoid tension, participants will lie in the supine position. The physiotherapist will locate the measurement point using a pencil. This point will be roughly halfway down the muscle, centered between the lateral aspect of the acromion process (bony point of the shoulder) and the insertion point on the deltoid tuberosity (bumpy area near the midpoint of the upper arm bone). The following will be assessed:
Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Measured: Baseline
Deltoid biomechanical properties
To assess the biomechanical properties of the deltoid muscle, participants will lie in the supine position. The physiotherapist will locate the measurement point using a pencil. This point will be roughly halfway down the muscle, centered between the lateral aspect of the acromion process (bony point of the shoulder) and the insertion point on the deltoid tuberosity (bumpy area near the midpoint of the upper arm bone). The following will be assessed:
Biomechanical properties: S-Dynamic Stiffness [N/m].
Measured: Baseline
Deltoid viscoelastic properties
To assess deltoid viscoelastic properties, participants will lie in the supine position. The physiotherapist will locate the measurement point using a pencil. This point will be roughly halfway down the muscle, centered between the lateral aspect of the acromion process (bony point of the shoulder) and the insertion point on the deltoid tuberosity (bumpy area near the midpoint of the upper arm bone). The following will be assessed:
Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Measured: Baseline
Biceps brahii state of tension
To assess biceps brachii tension, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The following will be assessed:
Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Measured: Baseline
Biceps brahii biomechanical properties
To assess the biomechanical properties of biceps brachii, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The following will be assessed:
Biomechanical properties: S-Dynamic Stiffness [N/m].
Measured: Baseline
Biceps brahii viscoelastic properties
To assess the biceps brachii viscoelastic properties, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The following will be assessed:
Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Measured: Baseline
Brachioradialis state of tension
To assess brachioradialis tension, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The device will be held vertically and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Measured: Baseline
Brachioradialis biomechanical properties
To assess the biomechanical properties of brachioradialis, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The device will be held vertically and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
Biomechanical properties: S-Dynamic Stiffness [N/m].
Measured: Baseline
Brachioradialis viscoelastic properties
To assess brachioradialis viscoelastic properties, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The device will be held vertically and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Measured: Baseline
Rectus femoris state of tension
To assess rectus femoris tension, participants will lie supine on a treatment table. The physiotherapist will locate the measurement point along the front of the thigh, approximately halfway between the anterior superior iliac spine (hip bone) and the top of the patella (kneecap). A pencil will be used to mark this point. The device will be held vertically, and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Measured: Baseline
Rectus femoris biomechanical properties
To assess the biomechanical properties of the rectus femoris, participants will lie supine on a treatment table. The physiotherapist will locate the measurement point along the front of the thigh, approximately halfway between the anterior superior iliac spine (hip bone) and the top of the patella (kneecap). A pencil will be used to mark this point. The device will be held vertically, and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
Biomechanical properties: S-Dynamic Stiffness [N/m].
Measured: Baseline
Rectus femoris viscoelastic properties
To assess rectus femoris viscoelastic properties, participants will lie supine on a treatment table. The physiotherapist will locate the measurement point along the front of the thigh, approximately halfway between the anterior superior iliac spine (hip bone) and the top of the patella (kneecap). A pencil will be used to mark this point. The device will be held vertically, and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed:
TViscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Measured: Baseline
Vastus medialis state of tension
To assess vastus medialis tension, participants will lie in a supine position on the treatment table with their legs extended. The physiotherapist will locate the measurement point on the inner thigh, approximately one hand-width above the superior-medial border of the patella (kneecap). This point should align with the visible bulge of the vastus medialis muscle. A pencil will be used to mark this point. The following will be assessed:
Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Measured: Baseline
Vastus medialis biomechanical properties
To assess vastus medialis biomechanical properties, participants will lie in a supine position on the treatment table with their legs extended. The physiotherapist will locate the measurement point on the inner thigh, approximately one hand-width above the superior-medial border of the patella (kneecap). This point should align with the visible bulge of the vastus medialis muscle.A pencil will be used to mark this point. The following will be assessed:
Biomechanical properties: S-Dynamic Stiffness [N/m].
Measured: Baseline
Vastus medialis viscoelastic properties
To assess vastus medialis viscoelastic properties, participants will lie in a supine position on the treatment table with their legs extended. The physiotherapist will locate the measurement point on the inner thigh, approximately one hand-width above the superior-medial border of the patella (kneecap). This point should align with the visible bulge of the vastus medialis muscle.A pencil will be used to mark this point. The following will be assessed:
Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Measured: Baseline
Vastus lateralis state of tension
To assess vastus lateralis tension, participants will lie in a supine position on the treatment table with their leg extended. The physiotherapist will locate the measurement point on the outer thigh, approximately one hand-width above the superior-lateral border of the patella (kneecap). This point should align with the pronounced bulge of the vastus lateralis muscle. The following will be assessed:
Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Measured: Baseline
Vastus lateralis biomechanical properties
To assess vastus lateralis biomechanical properties, participants will lie in a supine position on the treatment table with their leg extended. The physiotherapist will locate the measurement point on the outer thigh, approximately one hand-width above the superior-lateral border of the patella (kneecap). This point should align with the pronounced bulge of the vastus lateralis muscle. The following will be assessed:
Biomechanical properties: S-Dynamic Stiffness [N/m].
Measured: Baseline
Vastus lateralis viscoelastic properties
To assess vastus lateralis viscoelastic properties, participants will lie in a supine position on the treatment table with their leg extended. The physiotherapist will locate the measurement point on the outer thigh, approximately one hand-width above the superior-lateral border of the patella (kneecap). This point should align with the pronounced bulge of the vastus lateralis muscle. The following will be assessed:
Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Measured: Baseline
Tibialis anterior state of tension
To assess tibialis anterior tension, participants will sit comfortably in a chair with their feet flat on the floor. The physiotherapist will locate the measurement point on the front of the lower leg, approximately one-third of the distance between the knee and the ankle. This point typically aligns with the most prominent bulge of the tibialis anterior muscle. The following will be assessed:
Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Measured: Baseline
Tibialis anterior biomechanical properties
To assess tibialis anterior biomechanical properties, participants will sit comfortably in a chair with their feet flat on the floor. The physiotherapist will locate the measurement point on the front of the lower leg, approximately one-third of the distance between the knee and the ankle. This point typically aligns with the most prominent bulge of the tibialis anterior muscle. The following will be assessed:
Biomechanical properties: S-Dynamic Stiffness [N/m].
Measured: Baseline
Tibialis anterior viscoelastic properties
To assess tibialis anterior viscoelastic properties, participants will sit comfortably in a chair with their feet flat on the floor. The physiotherapist will locate the measurement point on the front of the lower leg, approximately one-third of the distance between the knee and the ankle. This point typically aligns with the most prominent bulge of the tibialis anterior muscle. The following will be assessed:
Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start13 May 2024
- Primary completion30 Sep 2024
- Study completion9 Jan 2025
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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Crisan Alexandru Florian, Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
- Investigators
- Alexandru Crișan, PhD, Principal investigator, Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410950
- Sponsor's protocol ID
- 3654/04
- Status last verified
- Sep 2024
- First submitted
- 22 Apr 2024
- Last updated
- 10 Jan 2025
- 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 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Muscle Proprieties in COPD: a Non-invasive Evaluation of Respiratory and Limb Muscle Mechanics Using Myotonometry.
- ClinicalTrials.gov ID
- NCT06410950
- Acronym / sponsor ID
- 3654/04
- Conditions
- Copd, Muscle Weakness, Muscle Weakness Condition
- Keywords
- COPD, Muscle tone, Muscle stiffness, Muscle mechanical proprieties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș TimișoaraOther government
- Study start
- 13 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 13 May 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.
This study aims to determine if patients with Chronic Obstructive Pulmonary Disease (COPD) exhibit altered muscle properties (specifically changes in tone and stiffness) in both their respiratory muscles and skeletal muscles when compared to healthy individuals. The study will utilize the Myotonometer, a non-invasive device, to assess these properties.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) leads to progressive airflow limitation and respiratory muscle dysfunction, contributing to exercise intolerance and reduced quality of life. While existing methods evaluate overall lung function, the assessment of specific respiratory muscle properties remains challenging. Myotonometry offers a non-invasive technique to quantify muscle tone and stiffness, potentially providing insights into respiratory and skeletal muscle mechanics in COPD. This study aims to explore differences in the mechanical properties of both superficial respiratory and skeletal muscles in patients with COPD compared to healthy controls using myotonometry. Investigators hypothesize that COPD patients will exhibit altered mechanical properties (e.g., increased stiffness and tone) in both superficial respiratory and skeletal muscles compared to healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD subjects | – | Diagnostic Test: MyotonPRO Assessment of Muscle Biomechanical PropertiesIndividuals diagnosed with COPD based on GOLD spirometry criteria (post-bronchodilator FEV1/FVC ratio < 0.70). Stable COPD with no exacerbations requiring hospitalization in the past six months. Age range: 45-75 years old. |
| Healthy subjects | – | Diagnostic Test: MyotonPRO Assessment of Muscle Biomechanical PropertiesIndividuals with no history of chronic respiratory disease or recent infections. Normal lung function on spirometry (post-bronchodilator FEV1/FVC ratio > 0.70). Age range: 40-75 years old. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with COPD and healthy subjects
Key inclusion criteria (10 listed)
- Post-bronchodilator FEV1/FVC ratio < 0.70 Documented history of respiratory symptoms (e.g., dyspnea, cough, sputum production) Stable COPD: No COPD exacerbations requiring hospitalization in the past 6 months.
- Smoking History: Current or former smoker with a documented smoking history of at least 10 pack-years (cumulative cigarette consumption).
- Age: 45-75 years old. Ability to Understand and Follow Instructions: Mentally competent and able to understand the study procedures, risks, and benefits, providing written informed consent.
- No History of Respiratory Disease: free from any current or past respiratory diagnoses, including asthma, chronic bronchitis, or recurrent respiratory infections.
- Normal lung function: spirometry testing will confirm normal lung function with a post-bronchodilator FEV1/FVC ratio > 0.70 and no evidence of airflow obstruction.
Key exclusion criteria (11 listed)
- Other respiratory disease than COPD. Severe COPD exacerbation: anyone with a COPD exacerbation requiring hospitalization within the last six months.
- Conditions limiting chest wall movement: severe kyphosis, ankylosing spondylitis, or similar conditions that significantly impact the ability to expand the chest wall and perform respiratory muscle assessments.
- Muscular or neuromuscular disorders: primary muscular diseases (e.g., muscular dystrophy) or neuromuscular disorders affecting muscle function (e.g., Parkinson's, multiple sclerosis).
- Recent Surgery or Trauma: Significant surgery or trauma within the past three months that might affect muscle function or the ability to perform assessments.
- Uncontrolled comorbidities: severe, uncontrolled medical conditions that could significantly impact muscle function or confound the study results (e.g., uncontrolled heart failure, advanced renal disease).
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 |
|---|---|---|
| MyotonPRO Assessment of Muscle Biomechanical PropertiesMuscle assessments will be conducted using the MyotonPRO (Myoton AS., Tallinn, Estonia) digital palpation device. Measurement patterns and subject data will be uploaded to the device via computer. Each evaluation will be performed bilaterally. Subjects' muscle measurement points will be marked prior to assessment. The physiotherapist will position the device perpendicular to the muscle body and apply downward pressure (18N). Pressure should be maintained until the device's probe light changes from red to green. Five measurement pulses will then be applied. Each pulse lasts 15 ms with an 8 ms interval between pulses. The SENIAM sensor location guide will be used to determine the approximate motor point for MyotonPRO measurements. | Diagnostic test | COPD subjects, Healthy subjects |
Primary outcome
Semispinalis capitis state of tension
Time frame: Baseline
To assess the tension of the semispinalis capitis (SC), participants will lie in a supine position on the treatment table. The physiotherapist will identify the measurement point using a pencil. This point will be located approximately two finger widths lateral to the spinous process of the C7 vertebra and slightly inferior to the occiput (base of the skull). The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Semispinalis capitis biomechanical properties
Time frame: Baseline
To assess the biomechanical properties of the semispinalis capitis (SC), participants will lie in a supine position on the treatment table. The physiotherapist will identify the measurement point using a pencil. This point will be located approximately two finger widths lateral to the spinous process of the C7 vertebra and slightly inferior to the occiput (base of the skull). The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: Biomechanical properties: S-Dynamic Stiffness [N/m].
Semispinalis capitis viscoelastic properties
Time frame: Baseline
To assess the viscoelastic properties of the semispinalis capitis (SC), participants will lie in a supine position on the treatment table. The physiotherapist will identify the measurement point using a pencil. This point will be located approximately two finger widths lateral to the spinous process of the C7 vertebra and slightly inferior to the occiput (base of the skull). The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Sternocleidomastoideus (SCM) state of tension
Time frame: Baseline
To assess the tension of the sternocleidomastoideus (SCM), participants will lie supine on the treatment table. The evaluator will locate the midpoint on a line between the mastoid process (behind the ear) and the clavicle (collarbone), marking this point with a pencil. The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Sternocleidomastoideus (SCM) biomechanical properties
Time frame: Baseline
To assess the biomechanical properties of the sternocleidomastoideus (SCM), participants will lie supine on the treatment table. The evaluator will locate the midpoint on a line between the mastoid process (behind the ear) and the clavicle (collarbone), marking this point with a pencil. The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: Biomechanical properties: S-Dynamic Stiffness [N/m].
Sternocleidomastoideus (SCM) viscoelastic properties
Time frame: Baseline
To assess the viscoelastic properties of the sternocleidomastoideus (SCM), participants will lie supine on the treatment table. The evaluator will locate the midpoint on a line between the mastoid process (behind the ear) and the clavicle (collarbone), marking this point with a pencil. The device will be held vertically and a consistent downward pressure of 18 Newtons (N) will be applied to the muscle belly. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Trapezius state of tension
Time frame: Baseline
To assess the tension of the trapezius, participants will sit upright in a chair with good back support. Their hips should touch the back of the chair, feet flat on the floor, and hands resting comfortably in their lap. Shoulders will be relaxed, and knees and hips bent at a 90-degree angle. The upper trapezius measurement point is midway between the C7 vertebra (prominent at the base of the neck) and the acromion (the bony tip of the shoulder). The following will be assessed: Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Trapezius biomechanical properties
Time frame: Baseline
To assess the biomechanical properties of the trapezius, participants will sit upright in a chair with good back support. Their hips should touch the back of the chair, feet flat on the floor, and hands resting comfortably in their lap. Shoulders will be relaxed, and knees and hips bent at a 90-degree angle. The upper trapezius measurement point is midway between the C7 vertebra (prominent at the base of the neck) and the acromion (the bony tip of the shoulder). The following will be assessed: Biomechanical properties: S-Dynamic Stiffness [N/m].
Trapezius viscoelastic properties
Time frame: Baseline
To assess the viscoelastic properties of the trapezius, participants will sit upright in a chair with good back support. Their hips should touch the back of the chair, feet flat on the floor, and hands resting comfortably in their lap. Shoulders will be relaxed, and knees and hips bent at a 90-degree angle. The upper trapezius measurement point is midway between the C7 vertebra (prominent at the base of the neck) and the acromion (the bony tip of the shoulder). The following will be assessed: Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Deltoid state of tension
Time frame: Baseline
To assess deltoid tension, participants will lie in the supine position. The physiotherapist will locate the measurement point using a pencil. This point will be roughly halfway down the muscle, centered between the lateral aspect of the acromion process (bony point of the shoulder) and the insertion point on the deltoid tuberosity (bumpy area near the midpoint of the upper arm bone). The following will be assessed: Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Deltoid biomechanical properties
Time frame: Baseline
To assess the biomechanical properties of the deltoid muscle, participants will lie in the supine position. The physiotherapist will locate the measurement point using a pencil. This point will be roughly halfway down the muscle, centered between the lateral aspect of the acromion process (bony point of the shoulder) and the insertion point on the deltoid tuberosity (bumpy area near the midpoint of the upper arm bone). The following will be assessed: Biomechanical properties: S-Dynamic Stiffness [N/m].
Deltoid viscoelastic properties
Time frame: Baseline
To assess deltoid viscoelastic properties, participants will lie in the supine position. The physiotherapist will locate the measurement point using a pencil. This point will be roughly halfway down the muscle, centered between the lateral aspect of the acromion process (bony point of the shoulder) and the insertion point on the deltoid tuberosity (bumpy area near the midpoint of the upper arm bone). The following will be assessed: Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Biceps brahii state of tension
Time frame: Baseline
To assess biceps brachii tension, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The following will be assessed: Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Biceps brahii biomechanical properties
Time frame: Baseline
To assess the biomechanical properties of biceps brachii, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The following will be assessed: Biomechanical properties: S-Dynamic Stiffness [N/m].
Biceps brahii viscoelastic properties
Time frame: Baseline
To assess the biceps brachii viscoelastic properties, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The following will be assessed: Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Brachioradialis state of tension
Time frame: Baseline
To assess brachioradialis tension, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The device will be held vertically and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Brachioradialis biomechanical properties
Time frame: Baseline
To assess the biomechanical properties of brachioradialis, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The device will be held vertically and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: Biomechanical properties: S-Dynamic Stiffness [N/m].
Brachioradialis viscoelastic properties
Time frame: Baseline
To assess brachioradialis viscoelastic properties, participants will lie supine on the treatment table with their arms at their sides and palms facing upwards. The physiotherapist will locate the measurement point on the front of the upper arm, approximately midway between the shoulder and elbow crease. Using a pencil, they will mark this point. The device will be held vertically and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Rectus femoris state of tension
Time frame: Baseline
To assess rectus femoris tension, participants will lie supine on a treatment table. The physiotherapist will locate the measurement point along the front of the thigh, approximately halfway between the anterior superior iliac spine (hip bone) and the top of the patella (kneecap). A pencil will be used to mark this point. The device will be held vertically, and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Rectus femoris biomechanical properties
Time frame: Baseline
To assess the biomechanical properties of the rectus femoris, participants will lie supine on a treatment table. The physiotherapist will locate the measurement point along the front of the thigh, approximately halfway between the anterior superior iliac spine (hip bone) and the top of the patella (kneecap). A pencil will be used to mark this point. The device will be held vertically, and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: Biomechanical properties: S-Dynamic Stiffness [N/m].
Rectus femoris viscoelastic properties
Time frame: Baseline
To assess rectus femoris viscoelastic properties, participants will lie supine on a treatment table. The physiotherapist will locate the measurement point along the front of the thigh, approximately halfway between the anterior superior iliac spine (hip bone) and the top of the patella (kneecap). A pencil will be used to mark this point. The device will be held vertically, and a steady downward pressure of 18 Newtons (N) will be applied directly over the marked point. Once the indicator light on the probe transitions from red to green, pressure will be maintained while the MyotonPRO delivers five stimulation pulses. The following will be assessed: TViscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Vastus medialis state of tension
Time frame: Baseline
To assess vastus medialis tension, participants will lie in a supine position on the treatment table with their legs extended. The physiotherapist will locate the measurement point on the inner thigh, approximately one hand-width above the superior-medial border of the patella (kneecap). This point should align with the visible bulge of the vastus medialis muscle. A pencil will be used to mark this point. The following will be assessed: Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Vastus medialis biomechanical properties
Time frame: Baseline
To assess vastus medialis biomechanical properties, participants will lie in a supine position on the treatment table with their legs extended. The physiotherapist will locate the measurement point on the inner thigh, approximately one hand-width above the superior-medial border of the patella (kneecap). This point should align with the visible bulge of the vastus medialis muscle.A pencil will be used to mark this point. The following will be assessed: Biomechanical properties: S-Dynamic Stiffness [N/m].
Vastus medialis viscoelastic properties
Time frame: Baseline
To assess vastus medialis viscoelastic properties, participants will lie in a supine position on the treatment table with their legs extended. The physiotherapist will locate the measurement point on the inner thigh, approximately one hand-width above the superior-medial border of the patella (kneecap). This point should align with the visible bulge of the vastus medialis muscle.A pencil will be used to mark this point. The following will be assessed: Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Vastus lateralis state of tension
Time frame: Baseline
To assess vastus lateralis tension, participants will lie in a supine position on the treatment table with their leg extended. The physiotherapist will locate the measurement point on the outer thigh, approximately one hand-width above the superior-lateral border of the patella (kneecap). This point should align with the pronounced bulge of the vastus lateralis muscle. The following will be assessed: Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Vastus lateralis biomechanical properties
Time frame: Baseline
To assess vastus lateralis biomechanical properties, participants will lie in a supine position on the treatment table with their leg extended. The physiotherapist will locate the measurement point on the outer thigh, approximately one hand-width above the superior-lateral border of the patella (kneecap). This point should align with the pronounced bulge of the vastus lateralis muscle. The following will be assessed: Biomechanical properties: S-Dynamic Stiffness [N/m].
Vastus lateralis viscoelastic properties
Time frame: Baseline
To assess vastus lateralis viscoelastic properties, participants will lie in a supine position on the treatment table with their leg extended. The physiotherapist will locate the measurement point on the outer thigh, approximately one hand-width above the superior-lateral border of the patella (kneecap). This point should align with the pronounced bulge of the vastus lateralis muscle. The following will be assessed: Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
Tibialis anterior state of tension
Time frame: Baseline
To assess tibialis anterior tension, participants will sit comfortably in a chair with their feet flat on the floor. The physiotherapist will locate the measurement point on the front of the lower leg, approximately one-third of the distance between the knee and the ankle. This point typically aligns with the most prominent bulge of the tibialis anterior muscle. The following will be assessed: Tone or state of tension: F - Natural Oscillation Frequency [Hz].
Tibialis anterior biomechanical properties
Time frame: Baseline
To assess tibialis anterior biomechanical properties, participants will sit comfortably in a chair with their feet flat on the floor. The physiotherapist will locate the measurement point on the front of the lower leg, approximately one-third of the distance between the knee and the ankle. This point typically aligns with the most prominent bulge of the tibialis anterior muscle. The following will be assessed: Biomechanical properties: S-Dynamic Stiffness [N/m].
Tibialis anterior viscoelastic properties
Time frame: Baseline
To assess tibialis anterior viscoelastic properties, participants will sit comfortably in a chair with their feet flat on the floor. The physiotherapist will locate the measurement point on the front of the lower leg, approximately one-third of the distance between the knee and the ankle. This point typically aligns with the most prominent bulge of the tibialis anterior muscle. The following will be assessed: Viscoelastic properties: R-Mechanical Stress Relaxation Time [ms].
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 10 Jan 2025.
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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.
Alexandru Crișan, PhD principal investigator
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
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 and Muscle Weakness, run by Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara at 1 site in Romania.
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 10 inclusion and 11 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 10 Jan 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 Romania. 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?
Semispinalis capitis state of tension (time frame: Baseline). The study lists 30 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 10 Jan 2025.