NCT05771506

Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Biruni University · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
OTHER	Balance Assessment	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.
OTHER	Pulmonary function test	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.
OTHER	Respiratory muscle strength test	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.
OTHER	Peripheral muscle strength test	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.
OTHER	6-minute walk test	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.
OTHER	Cognitive assessment	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

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2023-03-16
• Last updated: 2023-07-06

Locations

1 site across 1 country: Turkey (Türkiye)