An Investigation of the Cervical Region Biomechanics in Patients With Chronic Obstructive Pulmonary Disease

NCT06246370 | Unknown

• 1 other identifier: GO 23/616
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate cervical region biomechanics, muscle performance and respiratory muscle strength in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy subjects.

Conditions

Chronic Obstructive Pulmonary Disease; Postural; Defect; Cervical Pain; Cough

Outcome Measures

Primary Outcomes (9)

• Evaluation of sagittal cobb angle

  Cobb anle will measure from X-ray imagination between T2- T12 level.

  day 1

• Cranial rotation angle

  Tragus- eye horizontal angle will measure from lateral cervical photographs.

  day 1

• evaluation of cervical region biomechanic (dynamic)

  Investigation of the cervical region range of motions of cervical flexion, cervical extension, cervical lateral flexion, and cervical rotation range of motion.

  day 1

• cervical inclination angle

  tragus eye and C7 level horizontal angle will measure from lateral cervical photographs.

  day 1

• cervical lateral flexion angle

  the angle between pogonion-tragus and C7 level will measure from lateral cervical photographs.

  day 1

• Shoulder elevation/depression angle

  the angle between acromion- C7 level and horizontal line will measure from lateral cervical photographs.

  day 1

• chest wall analysis

  the distance between 3rd, 7th and 9th ribs and horizontal line will measure from X-Ray

  day 1

• rib angle

  Sternum and 4th,5th, 6th rib will mark and the angle between these and maximum anteroposteror dimention of the thorax will measure from X-Ray.

  day 1

• diaphragma height

  the distance between T1- and L2 level will measure from X-Ray.

  day 1

Secondary Outcomes (15)

• postural analysis

  day 1

• respiratory muscle strength

  day 1

• cervical region muscle strength and endurance

  day 1

• airway flow limitation

  day 1

• management of cough

  day 1

Study Arms (2)

COPD group

patients with COPD aged 40 years and above.

control group

aged matced healty patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred by the department of chest diseases of Hacettepe university will be taken

You may qualify if:

• Being diagnosed with stage 1-2-3-4 according to the Classification of Airflow Limitation in COPD (GOLD) system,
• Being \>40 years old,
• Being cognitively competent to understand and answer evaluation questions.
• Being clinically stable for the last 4 weeks,
• Being under control of accompanying comorbid conditions (such as hypertension, diabetes),
• Volunteering to participate in the research.

You may not qualify if:

• Having been hospitalized due to exacerbation in the last 3 months,
• Having a musculoskeletal, neurological, rheumatological or oncological disease that affects the craniocervical \& cervicothoracic joints and/or may prevent evaluation,
• Having undergone any surgical intervention on the craniocervicofacial region and spine in the last six months,
• Having lung malignancy, neoplasm, adenocarcinoma,
• Being a lung cancer patient or having received cancer treatment (head and neck lung radiotherapy), having undergone pneumonectemia, lobectomy or resection surgery,
• Being treated for anxiety and depression,
• Having scoliosis,
• Having a congenital anomaly of the craniocervicofacial region.
• Having 3 out of 4 findings according to the diagnostic criteria for cervical radiculopathy,
• Having thoracic outlet syndrome (TOS)

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Health Sciences Faculty

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Neck Pain; Cough

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory

Study Officials

• Aynur Demirel

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AYNUR DEMIREL, PhD

CONTACT

+9053123051576; aynur.demirel@hacettepe.edu.tr

Aynur Demirel

CONTACT

+9053123051576; aynur.demirel@hacettepe.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD, Assoc. Prof.

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: February 7, 2024
• Study Start: February 20, 2024
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-01

Locations

TU (1)