Mechanical Muscle Proprieties in Patient with COPD

NCT ID: NCT06410950

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2025-01-09

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.

Conditions

Copd; Muscle Weakness; Muscle Weakness Condition

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

MyotonPRO Assessment of Muscle Biomechanical Properties

Intervention Type: DIAGNOSTIC_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.

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.

MyotonPRO Assessment of Muscle Biomechanical Properties

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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.

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

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.

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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara

OTHER_GOV

Sponsor Role: lead

Responsible Party

Crisan Alexandru Florian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandru Crișan, PhD

Role: PRINCIPAL_INVESTIGATOR

Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara

Locations

Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes

Timișoara, Timiș County, Romania

Countries

Romania

Other Identifiers

3654/04

Identifier Type: -

Identifier Source: org_study_id