Does Vestibular System Effected in Chronic Obstructive Pulmonary Disease Patients

Investigation of Vestibular System Influence in Individuals With Chronic Obstructive Pulmonary Disease

. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vestibular Disorder
• Intervention / Treatment: Other: Respiratory Assessment; Other: Vestibular Assessment; Other: Balance Assessment

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Nimet Sermenli Aydın, MSc; Phone Number: +905079955111; Email: nimetsermenli@gmail.com
• Study Contact Backup: Name: Halit Selçuk, Msc; Phone Number: +905384855543; Email: selcukhalit@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD Group; Patients who are over 40 years old, diagnosed with COPD	Other: Respiratory Assessment; Spirometric measurement; Other Names: Respiratory Function Test; Other: Vestibular Assessment; Assessment of peripheral vestibular dysfunction, angular vestibule ocular reflex, vestibular dysfunction; Other Names: Head shake test; Head trust test; Unterberger test; Other: Balance Assessment; Postural stability; Other Names: Sensory organization test
Control Group; Healthy adults over 40 years old	Other: Respiratory Assessment; Spirometric measurement; Other Names: Respiratory Function Test; Other: Vestibular Assessment; Assessment of peripheral vestibular dysfunction, angular vestibule ocular reflex, vestibular dysfunction; Other Names: Head shake test; Head trust test; Unterberger test; Other: Balance Assessment; Postural stability; Other Names: Sensory organization test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vestibular Assessment 1	Head Shake Test:The head shake test is performed by shaking the head of the patient. The head is rotated at a comfortable range at a frequency of about 2 to 3 Hertz for 10- to 15 seconds. After shaking, the head remains in the center and the eyes of the patient are observed for nystagmus. The head shake test is used to look for signs of dynamic imbalance of vestibular function by evaluating the post-shaking nystagmus.	After the individuals permission, in first 4 minutes
Balance Assessment	Subjects stands on dual force plates and and their anterior posterior sway recorded in different test conditions.; Eyes open- stable support; Eyes closed- stable support; Eyes open- stable support; Eyes open-Foam surface; Eyes closed-Foam surface; Eyes open-Foam surface	After the individuals permission, in first 20 minutes
Respiratory Assessment - Spirometry - Forced expiratory volume in 1 s (FEV1)	*We will supply the information of test results from patients' folders.* Forced expiratory volume in 1 s (FEV1) Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.	After the individuals permission, in first 22 minutes
Respiratory Assessment - Spirometry - Forced vital capacity (FVC)	*We will supply the information of test results from patients' folders.* FVC, the maximum amount of air that can be exhaled when blowing out as fast as possible Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.	After the individuals permission, in first 22 minutes
Respiratory Assessment - Spirometry - Vital capacity (VC)	*We will supply the information of test results from patients' folders.* Vital capacity (VC), the maximum amount of air that can be exhaled when blowing out as fast as possible Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.	After the individuals permission, in first 22 minutes
Respiratory Assessment - Spirometry - Peak expiratory flow (PEF)	*We will supply the information of test results from patients' folders.* Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.	After the individuals permission, in first 22 minutes
Respiratory Assessment - Spirometry - Forced expiratory flow (FEF)	*We will supply the information of test results from patients' folders.* Forced expiratory flow, also known as mid-expiratory flow; the rates at 25%, 50% and 75% FVC are given Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.	After the individuals permission, in first 22 minutes
Respiratory Assessment - Spirometry - •Inspiratory vital capacity (IVC)	*We will supply the information of test results from patients' folders.* Inspiratory vital capacity (IVC), the maximum amount of air that can be inhaled after a full expiration Spirometry is the term given to the basic lung function -volume, time and flow- tests that measure the air that is expired and inspired. Spirometry is objective and noninvasive. Before performing the forced expiration, tidal (normal) breaths can be taken first, then a deep breath taken in while still using the mouthpiece, followed by a further quick, full inspiration.	After the individuals permission, in first 22 minutes
Vestibular Assessment 2	Head Trust Test: A brief, high-acceleration head thrust can test vestibular function of all semicircular canals. Depending on the semicircular canal tested, the head is rotated in a different direction. A corrective catch-up saccade is made in case of vestibular hypofunction.	After the individuals permission, in first 8 minutes
Vestibular Assessment 3	Unterberger test: Subjects will close their eyes and begin stepping in place for 60 seconds with shoulder at 90 degrees flexion, arms extended forward. The distance will be measured from the start point to end point.	After the individuals permission, in first 10 minutes

Collaborators and Investigators

• Sponsor: Nimet Sermenli Aydın

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 25, 2024
• Primary Completion (ANTICIPATED): May 15, 2024
• Study Completion (ANTICIPATED): June 15, 2024

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (ACTUAL): February 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: COPD; balance; vestibular dysfunction
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Vestibular Diseases
• Other Study ID Numbers: 061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No