Clinical trial NCT06246370: An Investigation of the Cervical Region Biomechanics in Patients With Chronic Obstructive Pulmonary Disease
Official title: Kronik Obstruktif Akciğer Hastalığında Servikal bölge Biyomekaniği, Kas Performansı ve Solunum Kas Kuvvetinin İncelenmesi
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Postural; Defect
Cervical Pain
Cough
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred by the department of chest diseases of Hacettepe university will be taken

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.

Detailed description: The secondary purposes are to investigate the correlation between cervical region biomechanics and posture, functional exercise capacity, depression \&anxiety level,neck disability, cough severity. In accordance with this purposes, 17 patients with COPD who have Global Initiative for Chronic Obstruction Lung Disease (GOLD) stage 1-2-3-4, being clinically stable for 4 weeks and 17 healthy controls will be included ages\>40. Tests and questionnaires will be used in order to determine the severity of COPD and to evaluate posture. Photographical analysis in lateral and posterior views will be used for evaluation of cranioservical region static and dynamic biomechanics. To analyze of chest wall, radiographic evaluation will be performed. Goniometry will be used for evaluation dynamic craniocervical kinematic analysis. Cranioservical region muscle strength and endurance tests will be performed. Respiratory muscle strength tests and cough evaluation test will be performed. Neck disability index, cough evaluation test questionnare, beck depression and anxiety questionnares, Nordic Musculoskeletal questionnare will be used. 6 Minute Pegboard and Ring Test, 6 Minute Walk Test will be performed. According to the results to be obtained, relationship between cranioservical region biomechanics and posture will be investigated based on the severity of disease in patients with COPD. It will guide professional working in the field.

Eligibility criteria: Inclusion Criteria:

* • 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.

Exclusion Criteria:

* • 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)

Primary outcomes:
measure: Evaluation of sagittal cobb angle
timeFrame: day 1
measure: Cranial rotation angle
timeFrame: day 1
measure: evaluation of cervical region biomechanic (dynamic)
timeFrame: day 1
measure: cervical inclination angle
timeFrame: day 1
measure: cervical lateral flexion angle
timeFrame: day 1
measure: Shoulder elevation/depression angle
timeFrame: day 1
measure: chest wall analysis
timeFrame: day 1
measure: rib angle
timeFrame: day 1
measure: diaphragma height
timeFrame: day 1
Secondary outcomes:
measure: postural analysis
timeFrame: day 1
measure: respiratory muscle strength
timeFrame: day 1
measure: cervical region muscle strength and endurance
timeFrame: day 1
measure: airway flow limitation
timeFrame: day 1
measure: management of cough
timeFrame: day 1
measure: Upper Extremity Functional Capacity
timeFrame: day 1
measure: functional exercise capacity
timeFrame: day 1
measure: anxiety level
timeFrame: day 1
measure: general musculoskeletal pain level
timeFrame: day 1
measure: evaluation of cervical radiculopathy
timeFrame: day 1
measure: investigation of neck disability severity
timeFrame: day 1
measure: investigation of the disease severity
timeFrame: day 1
measure: investigation of the Pulmonary Function
timeFrame: day 1
measure: cough sufficiency in patients with COPD
timeFrame: day 1
measure: depression level
timeFrame: day 1
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Health Sciences Faculty
Study officials:
affiliation: Hacettepe University
name: Aynur Demirel
role: PRINCIPAL_INVESTIGATOR
References: