Impact of Acute Exercise Intensity and Pattern on Cytokine Function (AEX)

December 4, 2023 updated by: Jonathan Little, University of British Columbia
The immune system helps prevent illness, fights off infections, and repairs damaged tissues following an injury. However, when immune cells remain active for prolonged periods of time - a state known as "chronic inflammation" - they can contribute to the development and progression of chronic diseases like heart disease and diabetes. Exercise can reduce the risk of developing many of these diseases and at least part of the health benefits of exercise are due to the ability of exercise to reduce "chronic inflammation". The inflammation-lowering effects of exercise are typically captured by measuring hormone-like molecules released from immune cells called "cytokines" in the blood. In addition to changes in circulating cytokine levels, exercise may also alter how immune cells respond to these cytokines. How exercise intensity (i.e., how hard you are working during exercise) and pattern (i.e., exercising as a long continuous bout or in short intervals) impact the ability of immune cells to respond to cytokines is not well understood. A better understanding of how exercise intensity and pattern of exercise for reducing chronic inflammation may help determine the best types of exercises for improving health and preventing chronic diseases.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V1V7
        • UBC Okanagan

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-35 years of age
  • Body mass index between 18.5-30 kg/m^2
  • Free of cardiometabolic and autoimmune/inflammatory disease

Exclusion Criteria:

  • Competitive endurance athlete
  • Cigarette smoker
  • Currently taking immunomodulatory/anti-inflammatory medications
  • Currently pregnant

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Resting (no exercise) control
Resting (no exercise) control condition
Other: Resting (no exercise) control
Participants will remain in a rested state (i.e., no exercise) for the entire session. Blood samples will be obtained at the same time-points as the exercise sessions.
Other Names:
  • CTL
Experimental: Moderate intensity continuous exercise (MICE)
Experimental session involving an acute bout of moderate intensity continuous exercise (MICE; continous cycling expending 350 kcal at 70% of lactate threshold)
Other: Moderate intensity continuous exercise
Participants will perform an acute bout of continuous cycling at 70% of the power output at lactate threshold until an energy expenditure of 350 kcal is achieved. Blood samples will be obtained immediately before and immediately, 30, and 90 minutes after exercise.
Other Names:
  • MICE
Experimental: High intensity continuous exercise (HICE)
Experimental session involving an acute bout of high intensity continuous exercise (HICE; continuous cycling expending 350 kcal at 10% of the difference between lactate threshold and VO2peak)
Other: High intensity continuous exercise
Participants will perform an acute bout of continuous cycling at 10% of the difference between lactate threshold and VO2peak until an energy expenditure of 350 kcal is achieved. Blood samples will be obtained immediately before and immediately, 30, and 90 minutes after exercise.
Other Names:
  • HICE
Experimental: High intensity interval exercise (HIIT)
Experimental session involving an acute bout of high intensity interval exercise (HIIT; cycling intervals expending 350 kcal at 10% of the difference between lactate threshold and VO2peak)
Other: High intensity interval exercise
Participants will perform an acute bout of interval cycling at at 10% of the difference between lactate threshold and VO2peak until an energy expenditure of 350 kcal is achieved. Blood samples will be obtained immediately before and immediately, 30, and 90 minutes after exercise.
Other Names:
  • HIIE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IL-10 mediated STAT3 phosphorylation
Time Frame: Change from pre-exercise to immediately and 90-min post-exercise
Ex vivo leukocyte STAT3 phosphorylation in response to IL-10 treatment
Change from pre-exercise to immediately and 90-min post-exercise

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
IL-10 mediated TNF-alpha inhibition
Time Frame: Change from pre-exercise to immediately and 90-min post-exercise
Ex vivo inhibition of TNF-alpha production in response to IL-10 treatment
Change from pre-exercise to immediately and 90-min post-exercise
IL-6 mediated STAT3 phosphorylation
Time Frame: Change from pre-exercise to immediately and 90-min post-exercise
Ex vivo leukocyte STAT3 phosphorylation in response to IL-6 treatment
Change from pre-exercise to immediately and 90-min post-exercise
IL-6 mediated TNF-alpha inhibition
Time Frame: Change from pre-exercise to immediately and 90-min post-exercise
Ex vivo inhibition of TNF-alpha production in response to IL-6 treatment
Change from pre-exercise to immediately and 90-min post-exercise
Plasma IL-10
Time Frame: Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Concentration of IL-10 in plasma samples
Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Plasma IL-6
Time Frame: Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Concentration of IL-6 in plasma samples
Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Plasma TNF-alpha
Time Frame: Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Concentration of TNF-alpha in plasma samples
Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Hematology panel
Time Frame: Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Complete blood count
Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Extracellular vesicles
Time Frame: Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Concentration of extracellular vesicles in plasma
Change from pre-exercise to immediately, 30-, and 90-min post-exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan P Little, PhD, UBC Okanagan

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AEX2022

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings