Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771506
• Other study ID #: buhucgun01
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2023
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
Turkey	Biruni University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Biruni University	Atlas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural stability test: Overall score		15-20 minutes
Primary	Stability limits test: Overall score		15-20 minutes
Primary	Sensory integration test of balance: Composite score		20-30 minutes
Primary	Forced vital capacity (FVC)		10-15 minutes
Primary	Forced expiratory volume in 1 second (FEV1)		10-15 minutes
Primary	FEV1/FVC		10-15 minutes
Primary	Forced expiratory flow 25-75% (FEF25-75)		10-15 minutes
Primary	Peak expiratory flow (PEF)		10-15 minutes
Primary	Maximal inspiratory pressure (MIP)		15-20 minutes
Primary	Maximal expiratory pressure (MEP)		15-20 minutes
Primary	Quadriceps muscle strength		15-20 minutes
Primary	6-minute walk test		15-20 minutes
Primary	MoCA test		10-15 minutes