- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05574413
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
Completed
Conditions
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Resting (no exercise) control
Resting (no exercise) control condition
|
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:
|
|
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)
|
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:
|
|
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)
|
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:
|
|
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)
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
September 15, 2022
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
October 6, 2022
First Submitted That Met QC Criteria
October 6, 2022
First Posted (Actual)
October 10, 2022
Study Record Updates
Last Update Posted (Actual)
December 6, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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