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

June 30, 2014 updated by: B. Hilvering, UMC Utrecht

Innate Immune Response to Anaerobe and Aerobe Exercise in Rowing Athletes

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.

Study Overview

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.

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

      • Utrecht, Netherlands, 3525BB
        • Rowing Centre "De Driewerf"

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 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 16 rowers
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.
Aerobic exercise: 2x30 min on an indoor rowing machine at 75% of Maximum heart rate
Anaerobic exercise: 3x1000m maximum effort, on an indoor rowing machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in neutrophil surface marker expression profiles over time
Time Frame: pre, 0h, 2h and 4h
FACS analysis of peripheral blood neutrophils. The changes in surface markers over time will be analysed by principal component analysis.
pre, 0h, 2h and 4h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional differences of neutrophil phenotypes before versus neutrophils that appear after exercise
Time Frame: pre and 2h post
Neutrophils: Oxidative burst, killing capacity of St. Aureus, chemotaxis
pre and 2h post
Changes in absolute cell count
Time Frame: pre, 0, 2h and 4h
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.
pre, 0, 2h and 4h

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences between anaerobic and aerobic exercise in neutrophil surface marker expression, functionality of neutrophils and absolute cell counts (granulocytes, lymphocytes and monocytes)
Time Frame: pre, 0h, 2h, 4h

Compare the peripheral blood leukocyte characteristics in the context of anaerobic versus aerobic exercise challenge

  • Surface marker expression
  • Functional differences
  • Absolute cell counts
pre, 0h, 2h, 4h

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Bart Hilvering, M.D., UMC Utrecht, department of Respiratory Medicine
  • Principal Investigator: Leo Koenderman, Professor, UMC Utrecht, department of Respiratory Medicine
  • Study Director: Daan Switters, UMC Utrecht

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

May 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (Estimate)

July 9, 2013

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • INCREASE-2013

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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