InflammationAEXNCT05574413
Impact of Acute Exercise Intensity and Pattern on Cytokine Function
A study testing Moderate intensity continuous exercise, High intensity continuous exercise and High intensity interval exercise in people with Inflammation, run by University of British Columbia at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Moderate intensity continuous exercise, High intensity continuous exercise and High intensity interval exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years of age
- Body mass index between 18.5-30 kg/m^2
- Free of cardiometabolic and autoimmune/inflammatory disease
Who cannot join
- Competitive endurance athlete
- Cigarette smoker
- Currently taking immunomodulatory/anti-inflammatory medications
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Inflammation
- Being tested
- Moderate intensity continuous exercise, High intensity continuous exercise, High intensity interval exercise, Resting (no exercise) control
- Keywords
- Exercise, Cytokines, Leukocytes, Interleukin-10, Interleukin-6
- Medical subject headings
- Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity continuous exerciseOther
Also called MICE
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.
High intensity continuous exerciseOther
Also called HICE
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.
High intensity interval exerciseOther
Also called HIIE
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.
Resting (no exercise) controlOther
Also called CTL
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.
| Study group | Role | What they receive |
|---|---|---|
| Resting (no exercise) control | Placebo comparator | Resting (no exercise) control condition Receives: Other: Resting (no exercise) control |
| Moderate intensity continuous exercise (MICE) | Experimental | Experimental session involving an acute bout of moderate intensity continuous exercise (MICE; continous cycling expending 350 kcal at 70% of lactate threshold) Receives: Other: Moderate intensity continuous exercise |
| High intensity continuous exercise (HICE) | Experimental | 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) Receives: Other: High intensity continuous exercise |
| High intensity interval exercise (HIIT) | Experimental | 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) Receives: Other: High intensity interval exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-10 mediated STAT3 phosphorylation
Ex vivo leukocyte STAT3 phosphorylation in response to IL-10 treatment
Measured: Change from pre-exercise to immediately and 90-min post-exercise
Secondary outcomes (8)
IL-10 mediated TNF-alpha inhibition
Ex vivo inhibition of TNF-alpha production in response to IL-10 treatment
Measured: Change from pre-exercise to immediately and 90-min post-exercise
IL-6 mediated STAT3 phosphorylation
Ex vivo leukocyte STAT3 phosphorylation in response to IL-6 treatment
Measured: Change from pre-exercise to immediately and 90-min post-exercise
IL-6 mediated TNF-alpha inhibition
Ex vivo inhibition of TNF-alpha production in response to IL-6 treatment
Measured: Change from pre-exercise to immediately and 90-min post-exercise
Plasma IL-10
Concentration of IL-10 in plasma samples
Measured: Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Plasma IL-6
Concentration of IL-6 in plasma samples
Measured: Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Plasma TNF-alpha
Concentration of TNF-alpha in plasma samples
Measured: Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Hematology panel
Complete blood count
Measured: Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Extracellular vesicles
Concentration of extracellular vesicles in plasma
Measured: Change from pre-exercise to immediately, 30-, and 90-min post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start15 Sep 2022
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated measures randomized counterbalanced crossover design
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
- Investigators
- Jonathan P Little, PhD, Principal investigator, UBC Okanagan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574413
- Sponsor's protocol ID
- AEX2022
- Acronym
- AEX
- Status last verified
- Dec 2023
- First submitted
- 6 Oct 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Exercise Intensity and Pattern on Cytokine Function
- ClinicalTrials.gov ID
- NCT05574413
- Acronym / sponsor ID
- AEX / AEX2022
- Conditions
- Inflammation
- Keywords
- Exercise, Cytokines, Leukocytes, Interleukin-10, Interleukin-6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Repeated measures randomized counterbalanced crossover design
| Arm | Type | Receives |
|---|---|---|
| Resting (no exercise) control | Placebo comparator | Other: Resting (no exercise) controlResting (no exercise) control condition |
| Moderate intensity continuous exercise (MICE) | Experimental | Other: Moderate intensity continuous exerciseExperimental session involving an acute bout of moderate intensity continuous exercise (MICE; continous cycling expending 350 kcal at 70% of lactate threshold) |
| High intensity continuous exercise (HICE) | Experimental | Other: High intensity continuous exerciseExperimental 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) |
| High intensity interval exercise (HIIT) | Experimental | Other: High intensity interval exerciseExperimental 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) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-35 years of age
- Body mass index between 18.5-30 kg/m^2
- Free of cardiometabolic and autoimmune/inflammatory disease
Key exclusion criteria (4 listed)
- Competitive endurance athlete
- Cigarette smoker
- Currently taking immunomodulatory/anti-inflammatory medications
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity continuous exerciseAlso: MICEParticipants 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 | Moderate intensity continuous exercise (MICE) |
| High intensity continuous exerciseAlso: HICEParticipants 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 | High intensity continuous exercise (HICE) |
| High intensity interval exerciseAlso: HIIEParticipants 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 | High intensity interval exercise (HIIT) |
| Resting (no exercise) controlAlso: CTLParticipants 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 | Resting (no exercise) control |
Primary outcome
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
8 secondary outcomes
IL-10 mediated TNF-alpha inhibition
Time frame: 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
IL-6 mediated TNF-alpha inhibition
Time frame: 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
Plasma IL-6
Time frame: 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
Hematology panel
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan P Little, PhD principal investigator
UBC Okanagan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity continuous exercise, High intensity continuous exercise and High intensity interval exercise in people with Inflammation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-10 mediated STAT3 phosphorylation (time frame: Change from pre-exercise to immediately and 90-min post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.