- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04117412
The Oxidative Stress, Inflammatory Markers, and Metabolomics Response to Exercise in Patients With COPD
January 12, 2023 updated by: Aslihan CAKMAK, Hacettepe University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of COPD (clinically stable)
- Being 40-80 years of age
- Able and willing to complete the informed consent process.
Exclusion Criteria:
- To have severe neuromuscular, musculoskeletal and rheumatic problems
- Unable to cooperate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients with COPD
Patients with COPD will undergo two different one bout of exercise training after maximal exercise test.
|
Same participants will undergo different one bout of exercise protocols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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
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.
|
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.
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.
|
Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aslihan Cakmak, MSc, Hacettepe University
- Study Director: Deniz Inal-Ince, PhD, Hacettepe University
- Principal Investigator: Emirhan Nemutlu, PhD, Hacettepe University
- Principal Investigator: Samiye Yabanoglu-Ciftci, PhD, Hacettepe University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2019
Primary Completion (Actual)
March 15, 2021
Study Completion (Actual)
March 15, 2021
Study Registration Dates
First Submitted
September 5, 2019
First Submitted That Met QC Criteria
October 3, 2019
First Posted (Actual)
October 7, 2019
Study Record Updates
Last Update Posted (Estimate)
January 13, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 18/1121-05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan
-
Wayne State UniversityUnknown