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

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.

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

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.

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