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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
    • Şahinbey
      • Gaziantep, Şahinbey, Turkey, 27000
        • Gaziantep Islamic Science and Technology University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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' [
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gaziantep Islam Science and Technology University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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