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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with COPD

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2019
Last Updated
January 12, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04117412
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Same participants will undergo two different exercise protocols after maximal exercise test.
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with COPD
Arm Type
Other
Arm Description
Patients with COPD will undergo two different one bout of exercise training after maximal exercise test.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Same participants will undergo different one bout of exercise protocols
Primary Outcome Measure Information:
Title
Response of total work values to maximal exercise test, high intensity interval and continuous exercise
Description
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.
Title
The inflammatory markers response to maximal exercise test, high intensity interval and continuous exercise
Description
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.
Title
The oxidative response to maximal exercise test, high intensity interval and continuous exercise
Description
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.
Title
The metabolomics response (valine-leucine-isoleucine, alanine) to maximal exercise test, high intensity interval, and continuous exercise.
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Inal-Ince, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aslihan Cakmak, MSc
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emirhan Nemutlu, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samiye Yabanoglu-Ciftci, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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