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Innate Immune Response to (An)Aerobic Exercise in Rowing Athletes (INCREASE)

Primary Purpose

Upper Respiratory Tract Infections, URTI

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Aerobic exercise
Anaerobic exercise
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Respiratory Tract Infections focused on measuring neutrophil, exercise, URTI, Innate, Immune

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Elite rower: rowing for 12 months or longer, >6 times a week.
  • Aged 18-25 years
  • Pretested(by exercise test*) maximum heart rate
  • Visiting Rowing club Triton, Orca or Viking
  • Performed a sports medical examination test (required for competing on a national level by the Royal Dutch Rowing Asscociation) *The exercise test is a multi step power test which builds up to maximum effort.

Exclusion Criteria:

  • Asthmatic
  • Current respiratory infection, sinusitis, otitis or any other sign of acute/ chronic inflammatory disease
  • Physically injured

Sites / Locations

  • Rowing Centre "De Driewerf"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

16 rowers

Arm Description

Adult rowers, aged between 18 and 25, training >6 times a week are subjected to both an aerobic and a an anaerobic exercise challenge. Between the two challenges there must a pause of at least a week.

Outcomes

Primary Outcome Measures

Change in neutrophil surface marker expression profiles over time
FACS analysis of peripheral blood neutrophils. The changes in surface markers over time will be analysed by principal component analysis.

Secondary Outcome Measures

Functional differences of neutrophil phenotypes before versus neutrophils that appear after exercise
Neutrophils: Oxidative burst, killing capacity of St. Aureus, chemotaxis
Changes in absolute cell count
Measuring the change in absolute cell count (granulocytes, lymphocytes, monocytes) over time. Timepoint 'pre' is considered to be the basal level and 0, 2 and 4h as points of change. Repeated measures ANOVA will be used to detect the change.

Full Information

First Posted
June 27, 2013
Last Updated
June 30, 2014
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT01893762
Brief Title
Innate Immune Response to (An)Aerobic Exercise in Rowing Athletes
Acronym
INCREASE
Official Title
Innate Immune Response to Anaerobe and Aerobe Exercise in Rowing Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Exercise induces innate immune response activation in athletes. The response starts during exercise and lasts for approximately 24 hours. This innate immune response shows similarities to the innate immune activation observed in, for example, bacterial infection and trauma. Immediately after exercise, athletes develop leukocytosis and cytokine production is altered towards an inflammatory pattern. However, to gain insight in immune response, a detailed cell receptor expression is required. To investigate the physiological innate immune response to exercise, we developed a model in rowers. Aim: To determine the type and degree of cellular inflammatory response in peripheral blood of elite rowing athletes after both anaerobe and aerobe exercise. Study design: Investigator driven, monocenter observational pilot study. Study population: 16 healthy, non-asthmatic, human volunteers, 18-25 year old. All competitive rowing athletes.
Detailed Description
Rationale: Exercise induces innate immune response activation in athletes. The response starts during exercise and lasts for approximately 24 hours. This innate immune response shows similarities to the innate immune activation observed in, for example, bacterial infection and trauma. Immediately after exercise, athletes develop leukocytosis and cytokine production is altered towards an inflammatory pattern. However, to gain insight in immune response, a detailed cell receptor expression is required. To investigate the physiological innate immune response to exercise, we developed a model in rowers. Objective: To determine the type and degree of cellular inflammatory response in peripheral blood of elite rowing athletes after both anaerobe and aerobe exercise. Study design: Investigator driven, monocenter observational pilot study. Study population: 16 healthy, non-asthmatic, human volunteers, 18-25 year old. All competitive rowing athletes. Intervention : All athletes perform two separate tests on a rowing ergometer. One anaerobe (flat out) exercise test (minutes) at day 1 and a aerobe test (1 hour) at day 2. Blood withdrawal of 9mL will be performed at four time points (1 pretest time point and 3 post: at 0h, 2 and 4h). Main study parameters/endpoints: The main endpoint is a rise in neutrophil cell count and the appearance of different subsets of neutrophils objectified by a change in receptor expression. Not only neutrophils are important in this innate cell response, other leukocytes like lymphocytes, monocytes and hematopoietic progenitor cells also play a role. Therefore the detailed analysis of receptor profiles on these cells will be measured by Flowcytometry. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The anaerobe and aerobe exercise tests do not differ significantly from what the athletes are used to do for training purposes. Athletes who experience any pain or discomfort during exercise will be advised to stop. Blood withdrawal on itself may cause a vasovagal response and especially well trained athletes are susceptible to develop this response. A trained physician is present to take care and look after rowers that suffered from vasovagal collapse. All anaerobe exercise brings along a very small risk of acute cardiovascular complications and although all rowers undergo exercise testing by an exercise physiologist before participating in competition, this risk remains. The total amount of time of the study is 2 times 5 hours. This time frame consists of the prior blood withdrawal, the testing itself and subsequently the three time points of blood withdrawal. The amount of blood withdrawal per athlete is 4 x 9mL, with a total of 36 mL per volunteer at one day of testing. The total blood withdrawal is therefore 72 mL base on two testing days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections, URTI
Keywords
neutrophil, exercise, URTI, Innate, Immune

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
16 rowers
Arm Type
Experimental
Arm Description
Adult rowers, aged between 18 and 25, training >6 times a week are subjected to both an aerobic and a an anaerobic exercise challenge. Between the two challenges there must a pause of at least a week.
Intervention Type
Biological
Intervention Name(s)
Aerobic exercise
Intervention Description
Aerobic exercise: 2x30 min on an indoor rowing machine at 75% of Maximum heart rate
Intervention Type
Biological
Intervention Name(s)
Anaerobic exercise
Intervention Description
Anaerobic exercise: 3x1000m maximum effort, on an indoor rowing machine
Primary Outcome Measure Information:
Title
Change in neutrophil surface marker expression profiles over time
Description
FACS analysis of peripheral blood neutrophils. The changes in surface markers over time will be analysed by principal component analysis.
Time Frame
pre, 0h, 2h and 4h
Secondary Outcome Measure Information:
Title
Functional differences of neutrophil phenotypes before versus neutrophils that appear after exercise
Description
Neutrophils: Oxidative burst, killing capacity of St. Aureus, chemotaxis
Time Frame
pre and 2h post
Title
Changes in absolute cell count
Description
Measuring the change in absolute cell count (granulocytes, lymphocytes, monocytes) over time. Timepoint 'pre' is considered to be the basal level and 0, 2 and 4h as points of change. Repeated measures ANOVA will be used to detect the change.
Time Frame
pre, 0, 2h and 4h
Other Pre-specified Outcome Measures:
Title
Differences between anaerobic and aerobic exercise in neutrophil surface marker expression, functionality of neutrophils and absolute cell counts (granulocytes, lymphocytes and monocytes)
Description
Compare the peripheral blood leukocyte characteristics in the context of anaerobic versus aerobic exercise challenge Surface marker expression Functional differences Absolute cell counts
Time Frame
pre, 0h, 2h, 4h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elite rower: rowing for 12 months or longer, >6 times a week. Aged 18-25 years Pretested(by exercise test*) maximum heart rate Visiting Rowing club Triton, Orca or Viking Performed a sports medical examination test (required for competing on a national level by the Royal Dutch Rowing Asscociation) *The exercise test is a multi step power test which builds up to maximum effort. Exclusion Criteria: Asthmatic Current respiratory infection, sinusitis, otitis or any other sign of acute/ chronic inflammatory disease Physically injured
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Hilvering, M.D.
Organizational Affiliation
UMC Utrecht, department of Respiratory Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leo Koenderman, Professor
Organizational Affiliation
UMC Utrecht, department of Respiratory Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daan Switters
Organizational Affiliation
UMC Utrecht
Official's Role
Study Director
Facility Information:
Facility Name
Rowing Centre "De Driewerf"
City
Utrecht
ZIP/Postal Code
3525BB
Country
Netherlands

12. IPD Sharing Statement

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Innate Immune Response to (An)Aerobic Exercise in Rowing Athletes

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