Mechanical Muscle Proprieties in Patient With COPD

Copd Clinical Trial

Official title:

Exploring Muscle Proprieties in COPD: a Non-invasive Evaluation of Respiratory and Limb Muscle Mechanics Using Myotonometry.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410950
• Other study ID #: 3654/04
• Status: Recruiting
• Start date: May 13, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: Spitalul Clinic de Boli Infec?ioase ?i Pneumoftiziologie Dr. Victor Babe? Timi?oara
• Contact: Alexandru Cri?an, PhD
• Phone: 0765525688
• Email: crisan[@]umft.ro
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The study will utilize the Myotonometer, a non-invasive device, to assess these properties.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion criteria for the COPD group:

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.

Exclusion criteria for the COPD group:

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).

Inclusion criteria for the healthy control group:

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.

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)

Exclusion criteria for the healthy control group:

Recent respiratory infection: anyone with a current respiratory tract infection (viral or bacterial) within the past four weeks.

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).

Related Conditions & MeSH terms

• Asthenia
• Copd
• Muscle Weakness
• Muscle Weakness Condition
• Paresis

Intervention

Diagnostic Test:
• MyotonPRO Assessment of Muscle Biomechanical Properties
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.

Locations

Country	Name	City	State
Romania	Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes	Timisoara	Timis

Sponsors (1)

Lead Sponsor	Collaborator
Spitalul Clinic de Boli Infec?ioase ?i Pneumoftiziologie Dr. Victor Babe? Timi?oara

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline
Primary	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].	Baseline