Chronic Obstructive Pulmonary DiseaseNCT05808621
Muscle Oxygenation in Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease and Chronic Obstructive Pulmonary Disease Exacerbation, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to examine the Peripheral Muscle Oxygenations at rest and in motion on the 2nd day of hospitalized patients and before discharge in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease and to compare the results in the hospital periods by repeating the tests in the stable periods… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Exacerbation, Muscle Oxygenation
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2023to 10 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
- No healthy volunteers
- Adult, Older adult
Study population: COPD hospitalized with Severe Acute Exacerbation
Who may be able to join
- Being a COPD patient hospitalized with Severe Acute Exacerbation
- be between 40-80 years old
- Having a Body Mass Index below 35
Who cannot join
- Patients who do not want to participate in the study
- Patients requiring intensive care follow-up during their hospitalization Arthritis, neurological disease, deep vein thrombosis, peripheral arterial disease, muscle weakness, broken etc. patients with the condition
- Extensive parenchyma such as malignancy, pulmonary embolism, vasculitis, collagen tissue diseases, interstitial fibrosis, severe pneumonia patients with damage
- Patients with severe dyspnea and hemodynamic instability who cannot perform the sit-up 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: Investigation of Peripheral Muscle Oxygenation at Rest and Movement in Hospitalized Patients in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Comparison With Stable Period
The aim of our study is to examine the Peripheral Muscle Oxygenations at rest and in motion on the 2nd day of hospitalized patients and before discharge in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease and to compare the results in the hospital periods by repeating the tests in the stable periods of the patients 1 month after discharge.
- Conditions
- Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Exacerbation, Muscle Oxygenation
- Keywords
- Chronic Obstructive Pulmonary Disease, Muscle Oxygenation, Chronic Obstructive Pulmonary Disease Exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 mm) device that measures regional blood flow and oxygenation by placing it on the skin non-invasively with near infrared spectroscopy (NIRS). The device, which has data collection and telemetric features, also allows O 2 measurement in non-laboratory environments and field-based research.
Measured: 4 weeks
Secondary outcomes (4)
1 minute sit and stand test
The test aims to assess your exercise capacity and leg muscle strength. The movement required is to get up from this chair with the legs straight and sit back continuing the repetitions as fast as possible within one minute.
The 1-minute STS test was performed with a chair of standard height of 46 cm without armrests. The patient was ensured to be seated upright on the chair positioned against a wall. The patient sat with the knees and hips flexed to 90°, feet placed flat on the floor hip-width apart, and the hands placed on the hips. Every get up from one's chair was validated to check if a complete sit-to-stand-to-sit sequence was achieved.
Measured: 4 weeks
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: 4 weeks
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: 4 weeks
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: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start8 Mar 2023
- Primary completion23 Jun 2024
- Study completion10 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
- NCT05808621
- Sponsor's protocol ID
- 2023-19
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 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
- Investigation of Peripheral Muscle Oxygenation at Rest and Movement in Hospitalized Patients in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Comparison With Stable Period
- ClinicalTrials.gov ID
- NCT05808621
- Acronym / sponsor ID
- 2023-19
- Conditions
- Chronic Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Disease Exacerbation, Muscle Oxygenation
- Keywords
- Chronic Obstructive Pulmonary Disease, Muscle Oxygenation, Chronic Obstructive Pulmonary Disease Exacerbation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 23 Jun 2024 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 11 Apr 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 our study is to examine the Peripheral Muscle Oxygenations at rest and in motion on the 2nd day of hospitalized patients and before discharge in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease and to compare the results in the hospital periods by repeating the tests in the stable periods of the patients 1 month after discharge.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD hospitalized with Severe Acute Exacerbation
Key inclusion criteria (3 listed)
- Being a COPD patient hospitalized with Severe Acute Exacerbation
- be between 40-80 years old
- Having a Body Mass Index below 35
Key exclusion criteria (4 listed)
- Patients who do not want to participate in the study
- Patients requiring intensive care follow-up during their hospitalization Arthritis, neurological disease, deep vein thrombosis, peripheral arterial disease, muscle weakness, broken etc. patients with the condition
- Extensive parenchyma such as malignancy, pulmonary embolism, vasculitis, collagen tissue diseases, interstitial fibrosis, severe pneumonia patients with damage
- Patients with severe dyspnea and hemodynamic instability who cannot perform the sit-up 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: 4 weeks
The muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21 mm) device that measures regional blood flow and oxygenation by placing it on the skin non-invasively with near infrared spectroscopy (NIRS). The device, which has data collection and telemetric features, also allows O 2 measurement in non-laboratory environments and field-based research.
4 secondary outcomes
1 minute sit and stand test
Time frame: 4 weeks
Modified Medical Research Council Dyspnea Scale:
Time frame: 4 weeks
COPD Assessment Test (CAT)
Time frame: 4 weeks
Charlson Comorbidity Index
Time frame: 4 weeks
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 Chronic Obstructive Pulmonary Disease Exacerbation, 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 3 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: 4 weeks). 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.