NCT06580353

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
Last Updated

November 22, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

August 26, 2024

Last Update Submit

November 21, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Respiratory functions (PEF)

    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

    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

    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

    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)

    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)

    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)

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

    1 Day

Study Arms (2)

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.

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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'.

You may qualify if:

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

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep İslamic Science and Technology University

Gaziantep, Şahinbey, 27000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 26, 2024

First Posted

August 30, 2024

Study Start

January 1, 2024

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

November 22, 2024

Record last verified: 2024-01

Locations