Does Vestibular System Effected in Chronic Obstructive Pulmonary Disease Patients

Sponsor
Nimet Sermenli Aydın (Other)
Overall Status
Unknown status
CT.gov ID
NCT04280211
Collaborator
(none)
20
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Investigation of Vestibular System Influence in Individuals With Chronic Obstructive Pulmonary Disease
Anticipated Study Start Date :
Feb 25, 2020
Anticipated Primary Completion Date :
May 15, 2020
Anticipated Study Completion Date :
Jun 15, 2020

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Vestibular Assessment 1 [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.

    2. Balance Assessment [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. Eyes open- stable support Eyes closed- stable support Eyes open- stable support Eyes open-Foam surface Eyes closed-Foam surface Eyes open-Foam surface

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

    4. Respiratory Assessment - Spirometry - Forced vital capacity (FVC) [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.

    5. Respiratory Assessment - Spirometry - Vital capacity (VC) [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.

    6. Respiratory Assessment - Spirometry - Peak expiratory flow (PEF) [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.

    7. Respiratory Assessment - Spirometry - Forced expiratory flow (FEF) [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.

    8. Respiratory Assessment - Spirometry - •Inspiratory vital capacity (IVC) [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.

    9. Vestibular Assessment 2 [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.

    10. Vestibular Assessment 3 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nimet Sermenli Aydın

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nimet Sermenli Aydın, Reseach Assisstant, Trakya University
    ClinicalTrials.gov Identifier:
    NCT04280211
    Other Study ID Numbers:
    • 061
    First Posted:
    Feb 21, 2020
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nimet Sermenli Aydın, Reseach Assisstant, Trakya University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2020