Studies
| Study First Submitted Date | 2020-02-06 |
| Study First Posted Date | 2020-02-21 |
| Last Update Posted Date | 2022-12-02 |
| Start Month Year | February 25, 2024 |
| Primary Completion Month Year | May 15, 2024 |
| Verification Month Year | December 2022 |
| Verification Date | 2022-12-31 |
| Last Update Posted Date | 2022-12-02 |
Detailed Descriptions
| Sequence: | 20800610 |
| 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. |
Conditions
| Sequence: | 52372678 |
| Name | Vestibular Disorder |
| Downcase Name | vestibular disorder |
Id Information
| Sequence: | 40302590 |
| Id Source | org_study_id |
| Id Value | 061 |
Design Groups
| Sequence: | 55817478 | Sequence: | 55817479 |
| Title | COPD Group | Title | Control Group |
| Description | Patients who are over 40 years old, diagnosed with COPD | Description | Healthy adults over 40 years old |
Interventions
| Sequence: | 52683319 | Sequence: | 52683320 | Sequence: | 52683321 |
| Intervention Type | Other | Intervention Type | Other | Intervention Type | Other |
| Name | Respiratory Assessment | Name | Vestibular Assessment | Name | Balance Assessment |
| Description | Spirometric measurement | Description | Assessment of peripheral vestibular dysfunction, angular vestibule ocular reflex, vestibular dysfunction | Description | Postural stability |
Keywords
| Sequence: | 80144614 | Sequence: | 80144615 | Sequence: | 80144616 |
| Name | vestibular dysfunction | Name | COPD | Name | balance |
| Downcase Name | vestibular dysfunction | Downcase Name | copd | Downcase Name | balance |
Design Outcomes
| Sequence: | 178124176 | Sequence: | 178124177 | Sequence: | 178124178 | Sequence: | 178124179 | Sequence: | 178124180 | Sequence: | 178124181 | Sequence: | 178124182 | Sequence: | 178124183 | Sequence: | 178124184 | Sequence: | 178124185 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Vestibular Assessment 1 | Measure | Balance Assessment | Measure | Respiratory Assessment – Spirometry – Forced expiratory volume in 1 s (FEV1) | Measure | Respiratory Assessment – Spirometry – Forced vital capacity (FVC) | Measure | Respiratory Assessment – Spirometry – Vital capacity (VC) | Measure | Respiratory Assessment – Spirometry – Peak expiratory flow (PEF) | Measure | Respiratory Assessment – Spirometry – Forced expiratory flow (FEF) | Measure | Respiratory Assessment – Spirometry – •Inspiratory vital capacity (IVC) | Measure | Vestibular Assessment 2 | Measure | Vestibular Assessment 3 |
| Time Frame | After the individuals permission, in first 4 minutes | Time Frame | After the individuals permission, in first 20 minutes | Time Frame | After the individuals permission, in first 22 minutes | Time Frame | After the individuals permission, in first 22 minutes | Time Frame | After the individuals permission, in first 22 minutes | Time Frame | After the individuals permission, in first 22 minutes | Time Frame | After the individuals permission, in first 22 minutes | Time Frame | After the individuals permission, in first 22 minutes | Time Frame | After the individuals permission, in first 8 minutes | Time Frame | After the individuals permission, in first 10 minutes |
| Description | 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. | Description | 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 | Description | *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. | Description | *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. | Description | *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. | Description | *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. | Description | *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. | Description | *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. | Description | 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. | Description | 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. |
Browse Conditions
| Sequence: | 194253395 | Sequence: | 194253396 | Sequence: | 194253397 | Sequence: | 194253398 | Sequence: | 194253399 | Sequence: | 194253400 | Sequence: | 194253401 | Sequence: | 194253402 | Sequence: | 194253403 | Sequence: | 194253404 | Sequence: | 194253405 |
| Mesh Term | Lung Diseases, Obstructive | Mesh Term | Pulmonary Disease, Chronic Obstructive | Mesh Term | Vestibular Diseases | Mesh Term | Lung Diseases | Mesh Term | Respiratory Tract Diseases | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes | Mesh Term | Labyrinth Diseases | Mesh Term | Ear Diseases | Mesh Term | Otorhinolaryngologic Diseases |
| Downcase Mesh Term | lung diseases, obstructive | Downcase Mesh Term | pulmonary disease, chronic obstructive | Downcase Mesh Term | vestibular diseases | Downcase Mesh Term | lung diseases | Downcase Mesh Term | respiratory tract diseases | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | labyrinth diseases | Downcase Mesh Term | ear diseases | Downcase Mesh Term | otorhinolaryngologic diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48507421 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Nimet Sermenli Aydın |
Central Contacts
| Sequence: | 12059980 | Sequence: | 12059981 |
| Contact Type | primary | Contact Type | backup |
| Name | Nimet Sermenli Aydın, MSc | Name | Halit Selçuk, Msc |
| Phone | +905079955111 | Phone | +905384855543 |
| nimetsermenli@gmail.com | selcukhalit@gmail.com | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 68423631 | Sequence: | 68423632 | Sequence: | 68423633 | Sequence: | 68423634 | Sequence: | 68423635 | Sequence: | 68423636 |
| Design Group Id | 55817478 | Design Group Id | 55817479 | Design Group Id | 55817478 | Design Group Id | 55817479 | Design Group Id | 55817478 | Design Group Id | 55817479 |
| Intervention Id | 52683319 | Intervention Id | 52683319 | Intervention Id | 52683320 | Intervention Id | 52683320 | Intervention Id | 52683321 | Intervention Id | 52683321 |
Eligibilities
| Sequence: | 30881910 |
| Sampling Method | Non-Probability Sample |
| Gender | All |
| Minimum Age | 40 Years |
| Maximum Age | 65 Years |
| Healthy Volunteers | Accepts Healthy Volunteers |
| 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. |
| 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 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254103694 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 40 |
| Maximum Age Num | 65 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 10 |
Designs
| Sequence: | 30627682 |
| Observational Model | Case-Control |
| Time Perspective | Cross-Sectional |
Intervention Other Names
| Sequence: | 26773340 | Sequence: | 26773341 | Sequence: | 26773342 | Sequence: | 26773343 | Sequence: | 26773344 |
| Intervention Id | 52683319 | Intervention Id | 52683320 | Intervention Id | 52683320 | Intervention Id | 52683320 | Intervention Id | 52683321 |
| Name | Respiratory Function Test | Name | Head shake test | Name | Head trust test | Name | Unterberger test | Name | Sensory organization test |
Responsible Parties
| Sequence: | 28994250 |
| Responsible Party Type | Sponsor-Investigator |
| Name | Nimet Sermenli Aydın |
| Title | Reseach Assisstant |
| Affiliation | Trakya University |