Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease
NCT number | NCT05771506 |
Other study ID # | buhucgun01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2023 |
Est. completion date | May 31, 2023 |
Verified date | July 2023 |
Source | Biruni University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Biruni University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Biruni University | Atlas University |
Turkey,
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 |
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