Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease

NCT05771506 | Completed

• 1 other identifier: buhucgun01
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (2)

COPD Group

Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment

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

Control Group

Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment

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

Interventions

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.

COPD Group; Control Group

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.

COPD Group; Control Group

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.

COPD Group; Control Group

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.

COPD Group; Control Group

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.

COPD Group; Control Group

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

COPD Group; Control Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Biruni University: lead
• Atlas University: collaborator

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Respiratory Physiological Phenomena; Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: January 1, 2023
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)