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CompletedNCT06580353Updated Nov 22, 2024

Viscoelastic Properties of Respiratory and Peripheral Muscles of COPD Patients

An observational study in COPD and Muscle Tone Abnormalities, sponsored by Gaziantep Islam Science and Technology University. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Gaziantep Islam Science and Technology University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
60
Ages
40 Years and older
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • COPD
  • Muscle Tone Abnormalities
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 60 is below the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Gaziantep Islam Science and Technology University is the lead sponsor of 42 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Male
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'.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • male gender,
  • body mass index (BMI) between 18.5-29.9 kg/m2,
  • stable COPD patients

Exclusion criteria

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.).
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Respiratory functions (PEF)

    Peak expiratory flow (PEF) were measured was evaluated with spirometry. It will be recorded as liters and expected percentage

    Time frame: 1 Day

  2. 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.

    Time frame: 1 Day

  3. 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.

    Time frame: 1 Day

  4. 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.

    Time frame: 1 Day

  5. 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

    Time frame: 1 Day

  6. 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

    Time frame: 1 Day

  7. Respiratory functions (FEV1/FVC)

    ratio of forced expiratory volume in the first second to vital capacity (FEV1/FVC) was evaluated with spirometry.

    Time frame: 1 Day

07

Study locations

1 site
  • Gaziantep İslamic Science and Technology University
    Gaziantep, Şahinbey 27000, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2024 to primary completion in Apr 2024, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2024
First posted
Aug 30, 2024
StartActual
Jan 1, 2024
Primary completionActual
Apr 1, 2024
CompletionActual
May 1, 2024
Last update
Nov 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06580353
Lead sponsor
Gaziantep Islam Science and Technology University
Responsible party
Çağtay Maden (Assistant professor, Gaziantep Islam Science and Technology University) — Principal investigator
First posted
Aug 30, 2024
Start date
Jan 1, 2024
Primary completion
Apr 1, 2024
Completion
May 1, 2024
Last update
Nov 22, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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