Chronic Obstructive Pulmonary DiseaseNCT04117412
The Oxidative Stress, Inflammatory Markers, and Metabolomics Response to Exercise in Patients With COPD
A study testing Exercise in people with Chronic Obstructive Pulmonary Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The effect of different physical exercise protocols on inflammatory markers, antioxidant balance, and metabolomics has not been fully elucidated. Therefore, the purpose of this study is to investigate the responses of oxidative stress, inflammatory markers, and metabolomics to exercise. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2019to 15 Mar 2021
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of COPD (clinically stable)
- Being 40-80 years of age
- Able and willing to complete the informed consent process.
Who cannot join
- To have severe neuromuscular, musculoskeletal and rheumatic problems
- Unable to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Oxidative Stress, Inflammatory Markers, and Metabolomics Response to Exercise in Patients With Chronic Obstructive Pulmonary Disease
The effect of different physical exercise protocols on inflammatory markers, antioxidant balance, and metabolomics has not been fully elucidated. Therefore, the purpose of this study is to investigate the responses of oxidative stress, inflammatory markers, and metabolomics to exercise.
Read the detailed description
Chronic obstructive pulmonary disease (COPD), one of the major causes of morbidity and mortality, is a preventable and curable disease characterized by irreversible airflow limitation. The progressive lung involvement, systemic inflammation, respiratory and peripheral muscle dysfunction, loss of muscle mass, and the dysfunction of the remaining muscles occur in COPD. Muscle dysfunction, which is defined as loss of strength or loss of endurance characteristics in muscles, is a comorbidity associated with poor outcomes such as frequent hospitalization and decreased survival, as well as adversely affecting exercise capacity and quality of life. Exercise increases mitochondrial activity and requires antioxidant defense to achieve cellular redox regulation. The effect of different physical exercise protocols on inflammatory markers, antioxidant balance, and metabolomics has not been fully elucidated. Oxidative stress, inflammatory markers, and metabolic responses to different acute exercise modalities in COPD patients need to be examined and clarified. Therefore, the purpose of this study is to investigate the responses of oxidative stress, inflammatory markers, and metabolomics to exercise. Detection of biomolecules that change with acute exercise may also contribute to the identification of exercise-related pathways.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Exercise
- 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.
ExerciseOther
Same participants will undergo different one bout of exercise protocols
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD | Other | Patients with COPD will undergo two different one bout of exercise training after maximal exercise test. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of total work values to maximal exercise test, high intensity interval and continuous exercise
Peak work rates will be determined using cycle ergometer. Maximal exercise test will be performed on the first day, high intensity interval and continuous exercise will be performed with one week intervals.
Measured: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
The inflammatory markers response to maximal exercise test, high intensity interval and continuous exercise
Blood samples will be collected before and after exercise and analyzed for the responses of IL-1, IL-6, TNF-α, sTNFr1. Maximal exercise test will be performed on the first day, high intensity interval and continuous exercise will be performed with one week intervals.
Measured: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
The oxidative response to maximal exercise test, high intensity interval and continuous exercise
Blood samples will be collected before and after exercise and analyzed for the responses of glutathione peroxidase, catalase, superoxide dismutase, glutathione, and total antioxidant status. Maximal exercise test will be performed on the first day, high intensity interval and continuous exercise will be performed with one week intervals.
Measured: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
The metabolomics response (valine-leucine-isoleucine, alanine) to maximal exercise test, high intensity interval, and continuous exercise.
Blood samples will be collected before and after exercise and analyzed for identification of metabolomics which change with exercise. Maximal exercise test will be performed on the first day, high intensity interval and continuous exercise will be performed with one week intervals.
Measured: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start15 Mar 2019
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Same participants will undergo two different exercise protocols after maximal exercise test.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Cakmak, Hacettepe University
- Investigators
- Deniz Inal-Ince, PhD, Study director, Hacettepe UniversityAslihan Cakmak, MSc, Principal investigator, Hacettepe UniversityEmirhan Nemutlu, PhD, Principal investigator, Hacettepe UniversitySamiye Yabanoglu-Ciftci, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117412
- Sponsor's protocol ID
- GO 18/1121-05
- Status last verified
- Jan 2023
- First submitted
- 5 Sep 2019
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cakmak A, Nemutlu E, Yabanoglu-Ciftci S, Baysal I, Kocaaga E, Coplu L, Inal-Ince D. Metabolomic, oxidative, and inflammatory responses to acute exercise in chronic obstructive pulmonary disease. Heart Lung. 2023 May-Jun;59:52-60. doi: 10.1016/j.hrtlng.2023.01.011. Epub 2023 Jan 30.
PubMed 36724589
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oxidative Stress, Inflammatory Markers, and Metabolomics Response to Exercise in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04117412
- Acronym / sponsor ID
- GO 18/1121-05
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 7 Oct 2019 (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 effect of different physical exercise protocols on inflammatory markers, antioxidant balance, and metabolomics has not been fully elucidated. Therefore, the purpose of this study is to investigate the responses of oxidative stress, inflammatory markers, and metabolomics to exercise.
Detailed description
Chronic obstructive pulmonary disease (COPD), one of the major causes of morbidity and mortality, is a preventable and curable disease characterized by irreversible airflow limitation. The progressive lung involvement, systemic inflammation, respiratory and peripheral muscle dysfunction, loss of muscle mass, and the dysfunction of the remaining muscles occur in COPD. Muscle dysfunction, which is defined as loss of strength or loss of endurance characteristics in muscles, is a comorbidity associated with poor outcomes such as frequent hospitalization and decreased survival, as well as adversely affecting exercise capacity and quality of life. Exercise increases mitochondrial activity and requires antioxidant defense to achieve cellular redox regulation. The effect of different physical exercise protocols on inflammatory markers, antioxidant balance, and metabolomics has not been fully elucidated. Oxidative stress, inflammatory markers, and metabolic responses to different acute exercise modalities in COPD patients need to be examined and clarified. Therefore, the purpose of this study is to investigate the responses of oxidative stress, inflammatory markers, and metabolomics to exercise. Detection of biomolecules that change with acute exercise may also contribute to the identification of exercise-related pathways.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Same participants will undergo two different exercise protocols after maximal exercise test.
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD | Other | Other: ExercisePatients with COPD will undergo two different one bout of exercise training after maximal exercise test. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COPD (clinically stable)
- Being 40-80 years of age
- Able and willing to complete the informed consent process.
Key exclusion criteria (2 listed)
- To have severe neuromuscular, musculoskeletal and rheumatic problems
- Unable to cooperate
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 |
|---|---|---|
| ExerciseSame participants will undergo different one bout of exercise protocols | Other | Patients with COPD |
Primary outcome
Response of total work values to maximal exercise test, high intensity interval and continuous exercise
Time frame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
Peak work rates will be determined using cycle ergometer. Maximal exercise test will be performed on the first day, high intensity interval and continuous exercise will be performed with one week intervals.
The inflammatory markers response to maximal exercise test, high intensity interval and continuous exercise
Time frame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
Blood samples will be collected before and after exercise and analyzed for the responses of IL-1, IL-6, TNF-α, sTNFr1. Maximal exercise test will be performed on the first day, high intensity interval and continuous exercise will be performed with one week intervals.
The oxidative response to maximal exercise test, high intensity interval and continuous exercise
Time frame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
Blood samples will be collected before and after exercise and analyzed for the responses of glutathione peroxidase, catalase, superoxide dismutase, glutathione, and total antioxidant status. Maximal exercise test will be performed on the first day, high intensity interval and continuous exercise will be performed with one week intervals.
The metabolomics response (valine-leucine-isoleucine, alanine) to maximal exercise test, high intensity interval, and continuous exercise.
Time frame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
Blood samples will be collected before and after exercise and analyzed for identification of metabolomics which change with exercise. Maximal exercise test will be performed on the first day, high intensity interval and continuous exercise will be performed with one week intervals.
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 Jan 2023.
- Derived from this study: PubMed 36724589Cakmak A, Nemutlu E, Yabanoglu-Ciftci S, Baysal I, Kocaaga E, Coplu L, Inal-Ince D. Metabolomic, oxidative, and inflammatory responses to acute exercise in chronic obstructive pulmonary disease. Heart Lung. 2023 May-Jun;59:52-60. doi: 10.1016/j.hrtlng.2023.01.011. Epub 2023 Jan 30.
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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.
Deniz Inal-Ince, PhD study director
Hacettepe University
Aslihan Cakmak, MSc principal investigator
Hacettepe University
Emirhan Nemutlu, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Chronic Obstructive Pulmonary Disease, run by Hacettepe 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 2 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 Jan 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?
Response of total work values to maximal exercise test, high intensity interval and continuous exercise (time frame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117412, which also lists 1 linked publication.
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 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.