Clinical trial NCT04280211: Does Vestibular System Effected in Chronic Obstructive Pulmonary Disease Patients
Official title: Investigation of Vestibular System Influence in Individuals With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vestibular Disorder
Keywords: vestibular dysfunction
COPD
balance
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group will be selected from Respiratory Disease Hospital - (Süreyyapaşa Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi) The control group will be invited from the community by announcements.

Brief summary: . The main question is whether the vestibular system is affected by COPD. If there is an influence, the second question is what is the relationship between balance and vestibular interaction in COPD patients. A total of 10 COPD patients and 10 healthy adults will include the study. Respiratory functions, vestibular functions and postural stability of participants will be assessed. This research is planned to be carried out as a cross-sectional/descriptive research. It's planned as a pilot study. Comparisons between study and control groups will be made with independent samples t-test for parametric values and Mann Whitney U for non-parametric values.

Detailed description: Chronic Obstructive Pulmonary Disorder (COPD) is a common preventable and treatable disease that is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Hypoxia caused by restrictive airflow is one of the symptoms of COPD. Hypoxia can affect the inner ear and vestibular nuclei. Also, balance impairment can be caused by hypoxia. Previous studies show that balance affected negatively in COPD patients. The aim of this study is to investigate of vestibular system influence in individuals with COPD. A total of 10 COPD patients and 10 healthy adults will include the study. This research is planned to be carried out as a cross-sectional/descriptive research. It's planned as a pilot study. Respiratory functions (respiratory function test), vestibular functions (head shake test, head trust test, unterberger test) and postural stability (sensory organization test) of participants will be assessed.Comparisons between study and control groups will be made with independent samples t-test for parametric values and Mann Whitney U for non-parametric values.

Eligibility criteria: For study group

Inclusion Criteria:

* Volunteering to participate in the study
* Diagnosed with COPD

Exclusion Criteria:

* Communication - Coordination problems of patients
* Using medicine which is increasing the risk of fall
* Any neurologic or musculoskeletal disorders which affect mobility and balance
* Loss of hearing

For control group

Inclusion Criteria:

* Volunteering to participate in the study

Exclusion Criteria:

* Communication - Coordination problems of patients
* Using medicine which is increasing the risk of fall
* Any neurologic, musculoskeletal or respiratory disorders which affect mobility and balance
* Loss of hearing

Primary outcomes:
measure: Vestibular Assessment 1
timeFrame: After the individuals permission, in first 4 minutes
measure: Balance Assessment
timeFrame: After the individuals permission, in first 20 minutes
measure: Respiratory Assessment - Spirometry - Forced expiratory volume in 1 s (FEV1)
timeFrame: After the individuals permission, in first 22 minutes
measure: Respiratory Assessment - Spirometry - Forced vital capacity (FVC)
timeFrame: After the individuals permission, in first 22 minutes
measure: Respiratory Assessment - Spirometry - Vital capacity (VC)
timeFrame: After the individuals permission, in first 22 minutes
measure: Respiratory Assessment - Spirometry - Peak expiratory flow (PEF)
timeFrame: After the individuals permission, in first 22 minutes
measure: Respiratory Assessment - Spirometry - Forced expiratory flow (FEF)
timeFrame: After the individuals permission, in first 22 minutes
measure: Respiratory Assessment - Spirometry - •Inspiratory vital capacity (IVC)
timeFrame: After the individuals permission, in first 22 minutes
measure: Vestibular Assessment 2
timeFrame: After the individuals permission, in first 8 minutes
measure: Vestibular Assessment 3
timeFrame: After the individuals permission, in first 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: