Does Vestibular System Effected in Chronic Obstructive Pulmonary Disease Patients
Investigation of Vestibular System Influence in Individuals With Chronic Obstructive Pulmonary Disease
1 other identifier
observational
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedStudy Start
First participant enrolled
February 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2024
CompletedDecember 2, 2022
December 1, 2022
3 months
February 6, 2020
December 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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. 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
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
Study Arms (2)
COPD Group
Patients who are over 40 years old, diagnosed with COPD
Control Group
Healthy adults over 40 years old
Interventions
Spirometric measurement
Assessment of peripheral vestibular dysfunction, angular vestibule ocular reflex, vestibular dysfunction
Postural stability
Eligibility Criteria
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.
You may qualify if:
- Volunteering to participate in the study
- Diagnosed with COPD
You may not qualify if:
- 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
- Volunteering to participate in the study
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Reseach Assisstant
Study Record Dates
First Submitted
February 6, 2020
First Posted
February 21, 2020
Study Start
February 25, 2024
Primary Completion
May 15, 2024
Study Completion
June 15, 2024
Last Updated
December 2, 2022
Record last verified: 2022-12