Chronic Obstructive Pulmonary DiseaseNCT05771506
Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by Biruni University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Balance Assessment, Pulmonary function test and Respiratory muscle strength test
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Balance Assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance AssessmentOther
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 testOther
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 testOther
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 testOther
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 testOther
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 assessmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| COPD Group | Balance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural stability test: Overall score
Measured: 15-20 minutes
Stability limits test: Overall score
Measured: 15-20 minutes
Sensory integration test of balance: Composite score
Measured: 20-30 minutes
Forced vital capacity (FVC)
Measured: 10-15 minutes
Forced expiratory volume in 1 second (FEV1)
Measured: 10-15 minutes
FEV1/FVC
Measured: 10-15 minutes
Forced expiratory flow 25-75% (FEF25-75)
Measured: 10-15 minutes
Peak expiratory flow (PEF)
Measured: 10-15 minutes
Maximal inspiratory pressure (MIP)
Measured: 15-20 minutes
Maximal expiratory pressure (MEP)
Measured: 15-20 minutes
Quadriceps muscle strength
Measured: 15-20 minutes
6-minute walk test
Measured: 15-20 minutes
MoCA test
Measured: 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Jan 2023
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Atlas University
- Responsible party
- Principal investigator, Hikmet Ucgun, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771506
- Sponsor's protocol ID
- buhucgun01
- Status last verified
- Jul 2023
- First submitted
- 6 Mar 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05771506
- Acronym / sponsor ID
- buhucgun01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Atlas University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Group | – | Other: Balance Assessment, Other: Pulmonary function test, Other: Respiratory muscle strength test, Other: Peripheral muscle strength test, Other: 6-minute walk test, Other: Cognitive assessmentBalance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment |
| Control Group | – | Other: Balance Assessment, Other: Pulmonary function test, Other: Respiratory muscle strength test, Other: Peripheral muscle strength test, Other: 6-minute walk test, Other: Cognitive assessmentBalance assessment, Pulmonary function test, Respiratory muscle strength test, Peripheral muscle strength test, 6-minute walk test, Cognitive assessment |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance AssessmentBalance 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 | COPD Group, Control Group |
| Pulmonary function testPulmonary 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 | COPD Group, Control Group |
| Respiratory muscle strength testRespiratory 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 | COPD Group, Control Group |
| Peripheral muscle strength testPeripheral 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 | COPD Group, Control Group |
| 6-minute walk testFunctional 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 | COPD Group, Control Group |
| Cognitive assessmentCognitive 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 | Other | COPD Group, Control Group |
Primary outcome
Postural stability test: Overall score
Time frame: 15-20 minutes
Stability limits test: Overall score
Time frame: 15-20 minutes
Sensory integration test of balance: Composite score
Time frame: 20-30 minutes
Forced vital capacity (FVC)
Time frame: 10-15 minutes
Forced expiratory volume in 1 second (FEV1)
Time frame: 10-15 minutes
FEV1/FVC
Time frame: 10-15 minutes
Forced expiratory flow 25-75% (FEF25-75)
Time frame: 10-15 minutes
Peak expiratory flow (PEF)
Time frame: 10-15 minutes
Maximal inspiratory pressure (MIP)
Time frame: 15-20 minutes
Maximal expiratory pressure (MEP)
Time frame: 15-20 minutes
Quadriceps muscle strength
Time frame: 15-20 minutes
6-minute walk test
Time frame: 15-20 minutes
MoCA test
Time frame: 10-15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural stability test: Overall score (time frame: 15-20 minutes). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.