Mechanical Properties of Peripheral and Accessory Respiratory Muscles in Chronic Obstructive Pulmonary Disease Patients

NCT06201403 | Recruiting

• 1 other identifier: COPD&Myoton
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The biomechanical properties of accessory respiratory muscles and peripheral muscles of COPD and healthy subjects will be measured and compared with the MyotonPro device.

Conditions

COPD

Outcome Measures

Primary Outcomes (8)

• M.Sternocleidomastoideus (SCM) myotonometric measurement

  To measure the tension of the SCM, participants will be asked to lie supine on the bed. The evaluator will mark the central point with a pencil on the line connecting the mastoid process and the clavicle bone and then take the measurement. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

  107 millisecond

• M. Trapezius myotonometric measurement

  Participants will be instructed to sit comfortably in a chair with back support, lean their hips against the back of the chair, and keep their pelvis stationary with their feet on the floor and their hands in their lap. The shoulders will be in a neutral position, the knee and hip joints will be flexed to 90 degrees, and the trunk will remain upright. The measurement point of the upper trapezius is the midpoint of the connection between C7 and the acromion. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

  107 millisecond

• M. Biceps brachii myotonometric measurement

  While the participants are in a supine position, measurements will be taken from the middle between the lateral acromion and the medial border of the cubital fossa. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device vertically. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

  107 millisecond

• M. Pectoralis Major (PM) myotonometric measurement

  To measure the muscular characteristics of the PM, participants will be asked to lie in a supine position with their hips neutrally positioned and their knees fully extended. The measurement point of PM is the intersection of the vertical line from the midpoint of the clavicle and the horizontal line from the axilla. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

  107 millisecond

• M. Rectus abdominis (RA) myotonometric measurement

  Participants will lie in a supine position, with bilateral legs hip-knee flexed, feet supported on the bed. The muscle tone of the RA muscle portion will be measured from a point approximately 3 cm next to the belly button. The probe will be placed perpendicular to the surface and pressure will be applied until the probe turns green. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

  107 millisecond

• M.Rectus femoris myotonometric measurement

  While the participants are in the supine position, measurements will be taken from the midpoint between the SIPS and the top of the patella. The physiotherapist will hold the device upright and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

  107 millisecond

• M.Vastus lateralis myotonometric measurement

  While the participants are in the supine position, measurement will be taken from the midpoint of the line from the upper pole of the patella to the greater trochanter. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device vertically. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

  107 millisecond

• M. Tibialis anterior myotonometric measurement

  While the participants are in the supine position, measurements will be taken from the head of the fibula to the medial malleolus and 2 cm laterally from one-third of the tibia. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device upright. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

  107 millisecond

Study Arms (2)

COPD Group

Patients diagnosed with COPD at Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Diagnostic Test: Determination of biomechanical properties of muscles

Healthy Group

Healthy individuals without any chronic or acute disease

Diagnostic Test: Determination of biomechanical properties of muscles

Interventions

Determination of biomechanical properties of muscles DIAGNOSTIC_TEST

All evaluations will be performed with a MyotonPRO (Myoton AS., Tallinn, Estonia) digital palpation device. The data of the cases to be evaluated and the patterns related to the measurements will be transferred to the device by establishing a computer connection. Measurements will be performed unilaterally. The measurement point of the subjects' unilateral muscles will first be marked with a pencil. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement.

COPD Group; Healthy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COPD and healthy adults

You may qualify if:

• Being diagnosed with group C and D COPD according to GOLD staging
• Having been using the same medications for the last 4 weeks
• No additional comorbid diseases of the orthopedic, neurological or cardiac system

You may not qualify if:

• Presence of another respiratory system disease other than COPD
• Patients who have had an acute COPD exacerbation in the last 4 weeks
• Patients experiencing COPD exacerbations during the study protocol
• Presence of fatty tissue at the measurement points, which may impair the measurement quality.
• Have already participated in another clinical trial within the last 30 days that may affect the results of the study.
• Being over 18 years of age
• Not having any diagnosed chronic disease
• Not being a smoker

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ESRA PEHLİVAN

CONTACT

09050585279; fztesrakambur@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: January 20, 2024
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

TU (1)