COPDNCT06580353
Viscoelastic Properties of Respiratory and Peripheral Muscles of COPD Patients
An observational study of COPD and Muscle Tone Abnormalities, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- COPD, Muscle Tone Abnormalities
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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'.
Who may be able to join
- male gender,
- body mass index (BMI) between 18.5-29.9 kg/m2,
- stable COPD patients
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep İslamic Science and Technology University
Gaziantep, Şahinbey, 27000
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD, Muscle Tone Abnormalities
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Respiratory functions (PEF)
Peak expiratory flow (PEF) were measured was evaluated with spirometry. It will be recorded as liters and expected percentage
Measured: 1 Day
The Medical Research Council Scale
Patients simply indicate on the scale the level of activity that causes dyspnoea in them according to the activities between 0-4.
Measured: 1 Day
The COPD Assessment Test
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.
Measured: 1 Day
Viscoelastic properties of muscles
The viscoelastic properties of the muscles (muscle tone (Hz), and elasticity (Relative), stiffness (N/m)) were measured using a hand-held myotonometer.
Measured: 1 Day
Respiratory functions (FEV1)
In pulmonary function test was evaluated with spirometry. forced expiratory volume in the first second (FEV1);will be recorded as liters and expected percentage
Measured: 1 Day
Respiratory functions (FVC)
In pulmonary function test was evaluated with spirometry. forced expiratory volume in the first second (FEV1);will be recorded as liters and expected percentage
Measured: 1 Day
Respiratory functions (FEV1/FVC)
ratio of forced expiratory volume in the first second to vital capacity (FEV1/FVC) was evaluated with spirometry.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Jan 2024
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağtay Maden, Gaziantep Islam Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580353
- Sponsor's protocol ID
- 2023/391
- Status last verified
- Jan 2024
- First submitted
- 26 Aug 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Viscoelastic Properties of Respiratory Muscles and Peripheral Muscles in Chronic Obstructive Pulmonary Disease Patients With Healthy Subjects
- ClinicalTrials.gov ID
- NCT06580353
- Acronym / sponsor ID
- 2023/391
- Conditions
- COPD, Muscle Tone Abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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'.
Key inclusion criteria (3 listed)
- male gender,
- body mass index (BMI) between 18.5-29.9 kg/m2,
- stable COPD patients
Key exclusion criteria (4 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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.
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Muscle Tone Abnormalities, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory functions (PEF) (time frame: 1 Day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.