Chronic Obstructive Pulmonary DiseaseNCT06041126
The Effect of Clinical Parameters on Muscle Oxygenation in Patients With COPD
An observational study of Chronic Obstructive Pulmonary Disease and Muscle Oxygenation, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the peripheral muscle oxygenation of patients with Chronic Obstructive Pulmonary Disease at rest, during submaximal exercise and recovery, and to examine the effects of disease severity and respiratory functions on peripheral muscle oxygenations. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Muscle Oxygenation, Disease Severity
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Apr 2023to 1 Mar 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stable COPD Patients
Who may be able to join
- Being diagnosed with COPD (according to GOLD Staging: GOLD 1, GOLD 2, GOLD 3, GOLD 4)
- Being between the ages of 40-80
- Body Mass Index <35
- Not having an acute exacerbation in the last 3 months
Who cannot join
- Patients who do not want to participate in the study
- Arthritis causing weakness in the lower extremity, neurological disease, deep vein thrombosis, peripheral arterial disease, muscle weakness, fracture etc. patients with the condition
- Common diseases such as malignancy, pulmonary embolism, vasculitis, collagen tissue diseases, interstitial fibrosis, severe pneumonia patients with parenchymal destruction
- Patients with severe dyspnea and hemodynamic instability who cannot perform the 6 Minute Walk Test
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Balıkesir
About this study
Official title: The Effect of Disease Severity and Respiratory Functions on Muscle Oxygenation in Stable COPD Patients
The aim of this study is to examine the peripheral muscle oxygenation of patients with Chronic Obstructive Pulmonary Disease at rest, during submaximal exercise and recovery, and to examine the effects of disease severity and respiratory functions on peripheral muscle oxygenations. In this study, the effect of disease severity and respiratory problems on peripheral muscle metabolism of patients with COPD will be explained.
- Conditions
- Chronic Obstructive Pulmonary Disease, Muscle Oxygenation, Disease Severity, Respiratory Function
- Keywords
- Chronic Obstructive Pulmonary Disease, Muscle Oxygenation, Disease Severity, Respiratory Function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group one | Patients with COPD according to the combined COPD assessment Global Intervention (GOLD) guidelines, participants who are in groups A and B (mild-moderate) will be included in group 1. | |
| Group two | COPD patients according to the combined COPD assessment, according to the "Global Intervention (GOLD) guidelines", participants who are in groups C and D (severe-very severe) will be included in group 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle oxygenation
The muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21
Measured: one day
Secondary outcomes (7)
Modified Medical Research Council Dyspnea Scale
Medical Research Council (MRC) Dyspnea Scale will be used to assess the severity of dyspnea. The severity of dyspnea during activities of daily living is graded from 0 to 4 on the Medical Research Council (MRC) Dyspnea Scale.
Measured: one day
COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) is a new scoring system for COPD patients, which provides a simple method for assessing the impact of COPD on the patient's health. Range of CAT scores from 0-40.
Measured: one day
Charlson Comorbidity Index
The Charlson Comorbidity Index was first developed in 1987 by Mary Charlson and colleagues as a weighted index to predict risk of death within 1 year of hospitalization for patients with specific comorbid conditions. Nineteen conditions were included in the index. The total score in the CCI is derived by summing the assigned weights of all comorbid conditions presented by the client. Higher scores indicate a more severe condition and consequently, a worse prognosis.
Measured: one day
Quadriceps muscle strength measurement
Quadriceps muscle strength measurement of the patients will be evaluated with a manual muscle strength measuring device (Lafayette Instrument, USA) and recorded in kg/force. In muscle strength measurements, maximal voluntary isometric contraction (make test), which is reported to be more reliable in the literature and is frequently used, will be used. It will be repeated three times in both lower extremities with an interval of 30 seconds and the highest measurement will be recorded. For quadriceps muscle strength measurement, the patients will be seated on the treatment table with their legs hanging down and the thigh will be fixed by placing a rolled towel under the knee joint of the side to be evaluated. In this position, the patient will be asked to extend until the knee is locked, and the resistance will be given just above the ankle joint.
Measured: one day
Six-minute walking test
It is a submaximal exercise capacity measurement test. The patient is asked to walk as briskly as possible on a flat surface of 30 meters for 6 minutes. In our study, the test will be carried out in a 30-meter corridor in accordance with the guidelines.
Measured: one day
Pulmonary Function Test
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria.
Measured: one day
Maximum Inspiratory Pressure / Maximum Expiratory Pressure Measurement
Respiratory muscle strength of individuals will be measured using an electronic and portable oral pressure measurement device, according to ATS / ERS criteria, with COSMED brand Pony FX model portable spirometer (COSMED, Italy). It is one of the most commonly used and noninvasive methods for the evaluation of respiratory muscle strength. With this method, maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are measured. MIP and MEP are intraoral pressures measured during maximal breathing against a valve that closes the airway during maximal inspiration and expiration.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start24 Apr 2023
- Primary completion23 Jun 2024
- Study completion1 Mar 2025
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulhan Yilmaz Gokmen, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041126
- Sponsor's protocol ID
- 2023-72
- Status last verified
- Mar 2025
- First submitted
- 27 Apr 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Disease Severity and Respiratory Functions on Muscle Oxygenation in Stable COPD Patients
- ClinicalTrials.gov ID
- NCT06041126
- Acronym / sponsor ID
- 2023-72
- Conditions
- Chronic Obstructive Pulmonary Disease, Muscle Oxygenation, Disease Severity, Respiratory Function
- Keywords
- Chronic Obstructive Pulmonary Disease, Muscle Oxygenation, Disease Severity, Respiratory Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 23 Jun 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 18 Sep 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 aim of this study is to examine the peripheral muscle oxygenation of patients with Chronic Obstructive Pulmonary Disease at rest, during submaximal exercise and recovery, and to examine the effects of disease severity and respiratory functions on peripheral muscle oxygenations. In this study, the effect of disease severity and respiratory problems on peripheral muscle metabolism of patients with COPD will be explained.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group one | – | –Patients with COPD according to the combined COPD assessment Global Intervention (GOLD) guidelines, participants who are in groups A and B (mild-moderate) will be included in group 1. |
| Group two | – | –COPD patients according to the combined COPD assessment, according to the "Global Intervention (GOLD) guidelines", participants who are in groups C and D (severe-very severe) will be included in group 2. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stable COPD Patients
Key inclusion criteria (4 listed)
- Being diagnosed with COPD (according to GOLD Staging: GOLD 1, GOLD 2, GOLD 3, GOLD 4)
- Being between the ages of 40-80
- Body Mass Index <35
- Not having an acute exacerbation in the last 3 months
Key exclusion criteria (4 listed)
- Patients who do not want to participate in the study
- Arthritis causing weakness in the lower extremity, neurological disease, deep vein thrombosis, peripheral arterial disease, muscle weakness, fracture etc. patients with the condition
- Common diseases such as malignancy, pulmonary embolism, vasculitis, collagen tissue diseases, interstitial fibrosis, severe pneumonia patients with parenchymal destruction
- Patients with severe dyspnea and hemodynamic instability who cannot perform the 6 Minute Walk Test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle oxygenation
Time frame: one day
The muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21
7 secondary outcomes
Modified Medical Research Council Dyspnea Scale
Time frame: one day
COPD Assessment Test (CAT)
Time frame: one day
Charlson Comorbidity Index
Time frame: one day
Quadriceps muscle strength measurement
Time frame: one day
Six-minute walking test
Time frame: one day
Pulmonary Function Test
Time frame: one day
Maximum Inspiratory Pressure / Maximum Expiratory Pressure Measurement
Time frame: one day
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 13 Mar 2025.
- 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 and Muscle Oxygenation, run by Bandırma Onyedi Eylül 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?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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 13 Mar 2025. 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?
Muscle oxygenation (time frame: one day). 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 13 Mar 2025.