Clinical trial NCT06410950: Mechanical Muscle Proprieties in Patient with COPD
Official title: Exploring Muscle Proprieties in COPD: a Non-invasive Evaluation of Respiratory and Limb Muscle Mechanics Using Myotonometry.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Copd
Muscle Weakness
Muscle Weakness Condition
Keywords: COPD
Muscle tone
Muscle stiffness
Muscle mechanical proprieties
Lead sponsor: Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
Sponsor class: OTHER_GOV
First posted: 2024-05-13
Enrollment: 87
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with COPD and healthy subjects

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Semispinalis capitis state of tension
timeFrame: Baseline
measure: Semispinalis capitis biomechanical properties
timeFrame: Baseline
measure: Semispinalis capitis viscoelastic properties
timeFrame: Baseline
measure: Sternocleidomastoideus (SCM) state of tension
timeFrame: Baseline
measure: Sternocleidomastoideus (SCM) biomechanical properties
timeFrame: Baseline
measure: Sternocleidomastoideus (SCM) viscoelastic properties
timeFrame: Baseline
measure: Trapezius state of tension
timeFrame: Baseline
measure: Trapezius biomechanical properties
timeFrame: Baseline
measure: Trapezius viscoelastic properties
timeFrame: Baseline
measure: Deltoid state of tension
timeFrame: Baseline
measure: Deltoid biomechanical properties
timeFrame: Baseline
measure: Deltoid viscoelastic properties
timeFrame: Baseline
measure: Biceps brahii state of tension
timeFrame: Baseline
measure: Biceps brahii biomechanical properties
timeFrame: Baseline
measure: Biceps brahii viscoelastic properties
timeFrame: Baseline
measure: Brachioradialis state of tension
timeFrame: Baseline
measure: Brachioradialis biomechanical properties
timeFrame: Baseline
measure: Brachioradialis viscoelastic properties
timeFrame: Baseline
measure: Rectus femoris state of tension
timeFrame: Baseline
measure: Rectus femoris biomechanical properties
timeFrame: Baseline
measure: Rectus femoris viscoelastic properties
timeFrame: Baseline
measure: Vastus medialis state of tension
timeFrame: Baseline
measure: Vastus medialis biomechanical properties
timeFrame: Baseline
measure: Vastus medialis viscoelastic properties
timeFrame: Baseline
measure: Vastus lateralis state of tension
timeFrame: Baseline
measure: Vastus lateralis biomechanical properties
timeFrame: Baseline
measure: Vastus lateralis viscoelastic properties
timeFrame: Baseline
measure: Tibialis anterior state of tension
timeFrame: Baseline
measure: Tibialis anterior biomechanical properties
timeFrame: Baseline
measure: Tibialis anterior viscoelastic properties
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes
state: Timis
Study officials:
affiliation: Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
name: Alexandru Crișan, PhD
role: PRINCIPAL_INVESTIGATOR
References: