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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Balance Assessment; Other: Pulmonary function test; Other: Respiratory muscle strength test; Other: Peripheral muscle strength test; Other: 6-minute walk test; Other: Cognitive assessment

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Biruni University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD aged between 40-65 years and healthy adults aged between 40-65 years will be included in the study. Informed consent forms for the study prepared for both the COPD group and the control group will be carefully explained and the participants will be included in the study after they have read, understood, and accepted.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD Group; Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment	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
Control Group; Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postural stability test: Overall score	15-20 minutes
Stability limits test: Overall score	15-20 minutes
Sensory integration test of balance: Composite score	20-30 minutes
Forced vital capacity (FVC)	10-15 minutes
Forced expiratory volume in 1 second (FEV1)	10-15 minutes
FEV1/FVC	10-15 minutes
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 strength	15-20 minutes
6-minute walk test	15-20 minutes
MoCA test	10-15 minutes

Collaborators and Investigators

• Sponsor: Biruni University
• Collaborators: Atlas University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: buhucgun01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No