Mechanical Muscle Proprieties in Patient with COPD

Completed

• Conditions: Muscle Weakness Condition; Copd; Muscle Weakness
• Interventions: Diagnostic Test: MyotonPRO Assessment of Muscle Biomechanical Properties

• Registration Number: NCT06410950
• Lead Sponsor: Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara

Brief 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.

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 Timeline

• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-05-07
• Study Start: 2024-05-13
• Study First Posted: 2024-05-13
• Status Verified: 2024-09
• Primary Completion: 2024-09-30
• Study Completion: 2025-01-09
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD subjects	MyotonPRO Assessment of Muscle Biomechanical Properties	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.
Healthy subjects	MyotonPRO Assessment of Muscle Biomechanical Properties	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.

Primary Outcome Measures

Name	Time	Method
Semispinalis capitis viscoelastic properties	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 \[ms\].
Trapezius biomechanical properties	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	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 \[ms\].
Semispinalis capitis biomechanical properties	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 \[N/m\].
Sternocleidomastoideus (SCM) state of tension	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 \[Hz\].
Trapezius state of tension	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 \[Hz\].
Deltoid state of tension	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 viscoelastic properties	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	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 viscoelastic properties	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	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 \[Hz\].
Vastus medialis state of tension	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 \[Hz\].
Semispinalis capitis state of tension	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 \[Hz\].
Sternocleidomastoideus (SCM) biomechanical properties	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 \[N/m\].
Deltoid biomechanical properties	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 \[N/m\].
Rectus femoris state of tension	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 \[Hz\].
Sternocleidomastoideus (SCM) viscoelastic properties	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 \[ms\].
Vastus medialis viscoelastic properties	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 \[ms\].
Biceps brahii biomechanical properties	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 \[N/m\].
Brachioradialis biomechanical properties	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	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 biomechanical properties	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	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 lateralis state of tension	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 \[Hz\].
Tibialis anterior state of tension	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	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 \[N/m\].
Vastus medialis biomechanical properties	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 lateralis biomechanical properties	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	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 viscoelastic properties	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 \[ms\].

Trial Locations

Locations (1)

Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes; 🇷🇴 Timisoara, Timis, Romania