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临床试验/NCT04280211
NCT04280211尚未招募不适用

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

Nimet Sermenli Aydın0 个研究点目标入组 20 人开始时间: 2024年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
主要终点
Vestibular Assessment 1

研究概览

简要总结

. 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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the study
  • Diagnosed with COPD

排除标准

  • 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

结局指标

主要结局

Vestibular Assessment 1

时间窗: After the individuals permission, in first 4 minutes

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.

Balance Assessment

时间窗: After the individuals permission, in first 20 minutes

Subjects stands on dual force plates and and their anterior posterior sway recorded in different test conditions. 1. Eyes open- stable support 2. Eyes closed- stable support 3. Eyes open- stable support 4. Eyes open-Foam surface 5. Eyes closed-Foam surface 6. Eyes open-Foam surface

Respiratory Assessment - Spirometry - Forced expiratory volume in 1 s (FEV1)

时间窗: After the individuals permission, in first 22 minutes

\*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.

Respiratory Assessment - Spirometry - Forced vital capacity (FVC)

时间窗: After the individuals permission, in first 22 minutes

\*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.

Respiratory Assessment - Spirometry - Vital capacity (VC)

时间窗: After the individuals permission, in first 22 minutes

\*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.

Respiratory Assessment - Spirometry - Peak expiratory flow (PEF)

时间窗: After the individuals permission, in first 22 minutes

\*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.

Respiratory Assessment - Spirometry - Forced expiratory flow (FEF)

时间窗: After the individuals permission, in first 22 minutes

\*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.

Respiratory Assessment - Spirometry - •Inspiratory vital capacity (IVC)

时间窗: After the individuals permission, in first 22 minutes

\*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.

Vestibular Assessment 2

时间窗: After the individuals permission, in first 8 minutes

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.

Vestibular Assessment 3

时间窗: After the individuals permission, in first 10 minutes

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.

次要结局

未报告次要终点

研究者

发起方
Nimet Sermenli Aydın
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nimet Sermenli Aydın

Reseach Assisstant

Trakya University

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