The Oxidative Stress, Inflammatory Markers, and Metabolomics Response to Exercise in Patients With COPD
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease
Started Mar 2019
Typical duration for not_applicable chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2019
CompletedFirst Submitted
Initial submission to the registry
September 5, 2019
CompletedFirst Posted
Study publicly available on registry
October 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2021
CompletedJanuary 13, 2023
January 1, 2023
2 years
September 5, 2019
January 12, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.
Study Arms (1)
Patients with COPD
OTHERPatients with COPD will undergo two different one bout of exercise training after maximal exercise test.
Interventions
Same participants will undergo different one bout of exercise protocols
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD (clinically stable)
- Being 40-80 years of age
- Able and willing to complete the informed consent process.
You may not qualify if:
- To have severe neuromuscular, musculoskeletal and rheumatic problems
- Unable to cooperate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 36724589DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Deniz Inal-Ince, PhD
Hacettepe University
- PRINCIPAL INVESTIGATOR
Aslihan Cakmak, MSc
Hacettepe University
- PRINCIPAL INVESTIGATOR
Emirhan Nemutlu, PhD
Hacettepe University
- PRINCIPAL INVESTIGATOR
Samiye Yabanoglu-Ciftci, PhD
Hacettepe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
September 5, 2019
First Posted
October 7, 2019
Study Start
March 15, 2019
Primary Completion
March 15, 2021
Study Completion
March 15, 2021
Last Updated
January 13, 2023
Record last verified: 2023-01