Clinical trial NCT05771506: Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease
Official title: Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Biruni University
Sponsor class: OTHER
Collaborators: name: Atlas University
First posted: 2023-03-16
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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 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

Primary outcomes:
measure: Postural stability test: Overall score
timeFrame: 15-20 minutes
measure: Stability limits test: Overall score
timeFrame: 15-20 minutes
measure: Sensory integration test of balance: Composite score
timeFrame: 20-30 minutes
measure: Forced vital capacity (FVC)
timeFrame: 10-15 minutes
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: 10-15 minutes
measure: FEV1/FVC
timeFrame: 10-15 minutes
measure: Forced expiratory flow 25-75% (FEF25-75)
timeFrame: 10-15 minutes
measure: Peak expiratory flow (PEF)
timeFrame: 10-15 minutes
measure: Maximal inspiratory pressure (MIP)
timeFrame: 15-20 minutes
measure: Maximal expiratory pressure (MEP)
timeFrame: 15-20 minutes
measure: Quadriceps muscle strength
timeFrame: 15-20 minutes
measure: 6-minute walk test
timeFrame: 15-20 minutes
measure: MoCA test
timeFrame: 10-15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
References: