Skip to content

Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease

Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05771506
Enrollment
46
Registered
2023-03-16
Start date
2023-01-01
Completion date
2023-05-31
Last updated
2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Brief 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.

Interventions

OTHERBalance 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.

OTHERPulmonary 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.

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.

OTHERPeripheral 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.

OTHER6-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.

OTHERCognitive 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

Sponsors

Atlas University
CollaboratorOTHER
Biruni University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Forced expiratory flow 25-75% (FEF25-75)10-15 minutes
Peak expiratory flow (PEF)10-15 minutes
Maximal inspiratory pressure (MIP)15-20 minutes
Maximal expiratory pressure (MEP)15-20 minutes
Quadriceps muscle strength15-20 minutes
6-minute walk test15-20 minutes
MoCA test10-15 minutes
Sensory integration test of balance: Composite score20-30 minutes
Forced vital capacity (FVC)10-15 minutes
Forced expiratory volume in 1 second (FEV1)10-15 minutes
FEV1/FVC10-15 minutes
Postural stability test: Overall score15-20 minutes
Stability limits test: Overall score15-20 minutes

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026