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Completed

NCT Number: NCT05771506

Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease

The primary aim of our study is to examine the relationship between balance and respiratory function, respiratory and peripheral muscle strength, functional capacity, and cognitive function in patients with Chronic Obstructive Pulmonary Disease (COPD). The secondary aim of our study is to compare respiratory function, respiratory and peripheral muscle strength, functional capacity, balance, and cognitive functions of COPD patients and healthy individuals. This study will examine and record the participant's sociodemographic information and medical records. Balance, respiratory function, respiratory and peripheral muscle strength, functional capacity, and cognitive function will be assessed. Since the patients are included in this study, no intervention will be made, no additional tests will be performed, or no changes will be made in the routine treatments of the patients during the study.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biruni University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

COPD Group Inclusion Criteria:

  • Being diagnosed with COPD in accordance with the GOLD criteria
  • Being between the ages of 40-65
  • To be able to speak, read, understand, and cooperate in Turkish
  • Being a volunteer to participate in the study

COPD Group Exclusion Criteria:

  • Having a COPD exacerbation in the last 8 weeks and/or having an unstable clinical condition
  • Having a diagnosed vision, hearing, or neurological disease that may affect balance
  • Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic disease or pathological condition that would affect assessments
  • Resting saturation below 90% during exercise tests
  • Being on long-term oxygen therapy

Control Group Inclusion Criteria:

  • Being between the ages of 40-65
  • To be able to speak, read, understand, and cooperate in Turkish
  • Being a volunteer to participate in the study

Control Group Exclusion Criteria:

  • Having a diagnosed vision, hearing, or neurological disease that may affect balance
  • Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic disease or pathological condition that would affect assessments
  • Resting saturation below 90% during exercise tests

Treatment and study plan

Balance assessment

Other

Balance assessment will be done with the "Biodex Balance System®" (Biodex Medical Systems, Shirley, New York, United States). Postural stability test overall score, stability limits test overall score, and sensory integration test of balance composite score will be recorded.

pulmonary function test

Other

Pulmonary function test will be performed with a spirometer ("COSMED Pony FX" (COSMED; Italy) in accordance with ATS/ERS criteria. Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC, peak expiratory volume measured at 25% and 75% of forced expiratory time (FEF 25-75%), and peak expiratory volume (PEF) parameters will be measured. The results will be recorded both as a percentage of measured values and expected values.

Respiratory muscle strength test

Other

Respiratory muscle strength will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values will be recorded. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.

Peripheral muscle strength test

Other

Peripheral muscle strength will be assessed by measuring M. Quadriceps muscle strength with a digital handheld dynamometer (MicroFET® Hoggan Scientific; USA). The test will be done in three measurements for the dominant side lower extremity. The average of the obtained values will be recorded in kilograms.

6-minute walk test

Other

Functional capacity will be assessed with the 6-minute walk test (6MWT). 6MWT will be performed in accordance with the criteria of the American Thoracic Society. The 6MWT distance will be recorded in meters.

Cognitive Assessment

Other

Cognitive function will be assessed with the Montreal Cognitive Assessment (MoCA) test. The MoCA test is a questionnaire developed to evaluate different cognitive functions and mild cognitive impairment. The maximum score that an individual can obtain from the test is 30, and a score of 21 or above is considered as mild cognitive impairment. Test; will be administered by a certified physiotherapist who has received training on practice and scoring directives

Primary outcomes

  1. Postural stability test: Overall score

    Time frame: 15-20 minutes

  2. Stability limits test: Overall score

    Time frame: 15-20 minutes

  3. Sensory integration test of balance: Composite score

    Time frame: 20-30 minutes

  4. Forced vital capacity (FVC)

    Time frame: 10-15 minutes

  5. Forced expiratory volume in 1 second (FEV1)

    Time frame: 10-15 minutes

  6. FEV1/FVC

    Time frame: 10-15 minutes

  7. Forced expiratory flow 25-75% (FEF25-75)

    Time frame: 10-15 minutes

  8. Peak expiratory flow (PEF)

    Time frame: 10-15 minutes

  9. Maximal inspiratory pressure (MIP)

    Time frame: 15-20 minutes

  10. Maximal expiratory pressure (MEP)

    Time frame: 15-20 minutes

  11. Quadriceps muscle strength

    Time frame: 15-20 minutes

  12. 6-minute walk test

    Time frame: 15-20 minutes

  13. MoCA test

    Time frame: 10-15 minutes

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Collaborators

  • Atlas University

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2023
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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