Clinical trial NCT04117412: The Oxidative Stress, Inflammatory Markers, and Metabolomics Response to Exercise in Patients With COPD
Official title: The Oxidative Stress, Inflammatory Markers, and Metabolomics Response to Exercise in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Same participants will undergo two different exercise protocols after maximal exercise test.
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response of total work values to maximal exercise test, high intensity interval and continuous exercise
timeFrame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
measure: The inflammatory markers response to maximal exercise test, high intensity interval and continuous exercise
timeFrame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
measure: The oxidative response to maximal exercise test, high intensity interval and continuous exercise
timeFrame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
measure: The metabolomics response (valine-leucine-isoleucine, alanine) to maximal exercise test, high intensity interval, and continuous exercise.
timeFrame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Deniz Inal-Ince, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Aslihan Cakmak, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Emirhan Nemutlu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Samiye Yabanoglu-Ciftci, PhD
role: PRINCIPAL_INVESTIGATOR
References: