NCT04117412

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

September 5, 2019

Last Update Submit

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

OTHER

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

Other: Exercise

Interventions

Same participants will undergo different one bout of exercise protocols

Patients with COPD

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Deniz Inal-Ince, PhD

    Hacettepe University

    STUDY DIRECTOR
  • Aslihan Cakmak, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Emirhan Nemutlu, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Samiye Yabanoglu-Ciftci, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Same participants will undergo two different exercise protocols after maximal exercise test.
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

Locations