- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06580353
Viscoelastic Properties of Respiratory and Peripheral Muscles of COPD Patients
November 21, 2024 updated by: Çağtay Maden, Gaziantep Islam Science and Technology University
Comparison of Viscoelastic Properties of Respiratory Muscles and Peripheral Muscles in Chronic Obstructive Pulmonary Disease Patients With Healthy Subjects
The aim of this study was to compare the viscoelastic properties of auxiliary respiratory muscles and peripheral muscles of chronic obstructive pulmonary disease patients with healthy subjects.
Myotonometry was used to evaluate the viscoelastic properties of the muscles.
The viscoelastic properties of the sternoclaidus mastoid, pectoralis major, upper trapezius, deltoid, biceps brachii, rectus femoris, gastrocinemius, and tibialis anterior muscles were evaluated.
Study Overview
Status
Completed
Conditions
Detailed Description
muscle viscoelastic properties; muscle tone, stiffness and elasticity.
These features may vary due to muscle overuse, lack of relaxation and recovery.
The aim is to investigate these differences in COPD patients and healthy individuals.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Şahinbey
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Gaziantep, Şahinbey, Turkey, 27000
- Gaziantep Islamic Science and Technology University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients with COPD who visited the chest diseases clinic and had symptoms of cough, sputum, and/or shortness of breath, along with tachypnea and/or tachycardia, that had not worsened in the past 14 days were classified as the 'Stable COPD group'.
Description
Inclusion Criteria:
- male gender,
- body mass index (BMI) between 18.5-29.9 kg/m2,
- stable COPD patients
Exclusion Criteria:
- being in the acute exacerbation period for COPD patients,
- having undergone any neurological, orthopaedic or thoracic surgery,
- presence of malignancy in any organ,
- presence of comorbidities affecting muscle atrophy (myasthenia gravis, muscular dystrophy, etc.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
COPD group
Patients with COPD who presented to the chest diseases polyclinic and whose symptoms of cough, sputum and/or dyspnoea accompanied by tachypnoea and/or tachycardia had not worsened in the last 14 days were defined as 'Stable COPD group' [
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Control group
The control group was defined as those who did not have any systemic disease and who were normal at the end of the polyclinic examination who applied to the chest diseases polyclinic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory functions (PEF)
Time Frame: 1 Day
|
Peak expiratory flow (PEF) were measured was evaluated with spirometry.
It will be recorded as liters and expected percentage
|
1 Day
|
|
The Medical Research Council Scale
Time Frame: 1 Day
|
Patients simply indicate on the scale the level of activity that causes dyspnoea in them according to the activities between 0-4.
|
1 Day
|
|
The COPD Assessment Test
Time Frame: 1 Day
|
This statement describes a scale consisting of eight items, each with response values ranging from 0 to 5. The total score is calculated by summing the responses to all the items, resulting in a range from 0 to 40.
A higher total score indicates a greater negative impact of the disease on the individual's quality of life and daily activities.
|
1 Day
|
|
Viscoelastic properties of muscles
Time Frame: 1 Day
|
The viscoelastic properties of the muscles (muscle tone (Hz), and elasticity (Relative), stiffness (N/m)) were measured using a hand-held myotonometer.
|
1 Day
|
|
Respiratory functions (FEV1)
Time Frame: 1 Day
|
In pulmonary function test was evaluated with spirometry.
forced expiratory volume in the first second (FEV1);will be recorded as liters and expected percentage
|
1 Day
|
|
Respiratory functions (FVC)
Time Frame: 1 Day
|
In pulmonary function test was evaluated with spirometry.
forced expiratory volume in the first second (FEV1);will be recorded as liters and expected percentage
|
1 Day
|
|
Respiratory functions (FEV1/FVC)
Time Frame: 1 Day
|
ratio of forced expiratory volume in the first second to vital capacity (FEV1/FVC) was evaluated with spirometry.
|
1 Day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
April 1, 2024
Study Completion (Actual)
May 1, 2024
Study Registration Dates
First Submitted
August 26, 2024
First Submitted That Met QC Criteria
August 28, 2024
First Posted (Actual)
August 30, 2024
Study Record Updates
Last Update Posted (Estimated)
November 22, 2024
Last Update Submitted That Met QC Criteria
November 21, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/391
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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