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NCT06410950Completed

Mechanical Muscle Proprieties in Patient with COPD

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

Source: ClinicalTrials.gov · Last updated 10 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
87 (actual)
First submitted
22 Apr 2024
Start date
13 May 2024
Primary completion date
30 Sept 2024
Lead sponsor
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
Diseases
COPD
NCT number
NCT06410950

What you commit to

  • Study type: Observational
  • Participants enrolled: 87
  • From 13 May 2024 to the primary completion date, 30 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Recent Surgery or Trauma: Significant surgery or trauma within the past three months that might affect muscle function or the ability to perform assessments.
  • Recent Surgery or Trauma: Significant surgery or trauma within the past three months that might affect muscle function or the ability to perform assessments.

Other illness

  • 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).
  • 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.
  • 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).
  • 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).

Other

  • Mild respiratory symptoms: Even mild, persistent respiratory symptoms (chronic cough, sputum production) within the past 4 weeks.

Who the study is looking for

  • 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)

Age in the registry: 45 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes
Coordinator of this site? Confirm its status
TimișoaraRomaniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.