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CompletedNCT04117412Updated Jan 13, 2023

The Oxidative Stress, Inflammatory Markers, and Metabolomics Response to Exercise in Patients With COPD

An interventional study of Exercise in Chronic Obstructive Pulmonary Disease, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-13.

Sponsored by Hacettepe University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2019, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 16 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of COPD (clinically stable)
  • Being 40-80 years of age
  • Able and willing to complete the informed consent process.

Exclusion criteria

Exclusion Criteria:

  • To have severe neuromuscular, musculoskeletal and rheumatic problems
  • Unable to cooperate
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Other
    Patients with COPD

    Patients with COPD will undergo two different one bout of exercise training after maximal exercise test.

    Other: Exercise

Interventions

  • OtherExercise

    Same participants will undergo different one bout of exercise protocols

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.

  2. 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.

    Time frame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.

  3. 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.

    Time frame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.

  4. 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.

    Time frame: Change from baseline to after maximal exercise test, high intensity interval, and continuous exercise, up to 3 weeks.

07

Study locations

1 site
  • Hacettepe University
    Ankara, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04117412
Lead sponsor
Hacettepe University
Responsible party
Aslihan Cakmak (Research Assistant, Hacettepe University) — Principal investigator
First posted
Oct 7, 2019
Start date
Mar 15, 2019
Primary completion
Mar 15, 2021
Completion
Mar 15, 2021
Last update
Jan 13, 2023

Study contacts

Deniz Inal-Ince, PhD
study director · Hacettepe University
Aslihan Cakmak, MSc
principal investigator · Hacettepe University
Emirhan Nemutlu, PhD
principal investigator · Hacettepe University
Samiye Yabanoglu-Ciftci, PhD
principal investigator · Hacettepe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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