NCT05574413

Brief 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 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.

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

Timeline
Completed

Started Sep 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

October 6, 2022

Last Update Submit

December 4, 2023

Conditions

Keywords

ExerciseCytokinesLeukocytesInterleukin-10Interleukin-6

Outcome Measures

Primary Outcomes (1)

  • IL-10 mediated STAT3 phosphorylation

    Ex vivo leukocyte STAT3 phosphorylation in response to IL-10 treatment

    Change from pre-exercise to immediately and 90-min post-exercise

Secondary Outcomes (8)

  • IL-10 mediated TNF-alpha inhibition

    Change from pre-exercise to immediately and 90-min post-exercise

  • IL-6 mediated STAT3 phosphorylation

    Change from pre-exercise to immediately and 90-min post-exercise

  • IL-6 mediated TNF-alpha inhibition

    Change from pre-exercise to immediately and 90-min post-exercise

  • Plasma IL-10

    Change from pre-exercise to immediately, 30-, and 90-min post-exercise

  • Plasma IL-6

    Change from pre-exercise to immediately, 30-, and 90-min post-exercise

  • +3 more secondary outcomes

Study Arms (4)

Resting (no exercise) control

PLACEBO COMPARATOR

Resting (no exercise) control condition

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)

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)

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)

Other: High intensity interval exercise

Interventions

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.

Also known as: MICE
Moderate intensity continuous exercise (MICE)

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.

Also known as: HICE
High intensity continuous exercise (HICE)

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.

Also known as: HIIE
High intensity interval exercise (HIIT)

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.

Also known as: CTL
Resting (no exercise) control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UBC Okanagan

Kelowna, British Columbia, V1V1V7, Canada

Location

MeSH Terms

Conditions

InflammationMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jonathan P Little, PhD

    UBC Okanagan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Repeated measures randomized counterbalanced crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 10, 2022

Study Start

September 15, 2022

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations